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Articles par catégorie

• Category: Non classé
  • UK – NICE recommends Janssen’s treatment for active psoriatic arthritis
  • Europe – Commission seeks 5-year extension MDR/IVDR delegated acts powers
  • USA – US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions
  • UK – Evusheld approved to prevent COVID-19 in people whose immune response is poor
  • USA – FDA offers guidance on patient-focused product development
  • Europe – MEPs call for a more effective EU strategy to beat cancer
  • USA – CES 2022: focus sur quatre entreprises en santé lauréates des « Innovation Awards »
  • UK – NICE pens two-year collaboration with the Academic Health Science Network
  • France – Health Data Hub: le ministère de la santé et la Cada refusent la publication des codes sources
  • France – Vaccins COVID-19 : l’ANSM publie les synthèses du comité d’experts sur les effets thrombotiques
  • Europe – Les E-Apps en santé : quand s’agit-il de DM ou de DIV ?
  • Europe – Data protection in the blood sector: challenges for European blood establishments
  • International – Who will get COVID-19 vaccine first in the world
  • Europe – Base de données EUDAMED pour les dispositifs médicaux : lancement du module destiné à l’enregistrement des opérateurs
  • France – La Dépakine, produite par Sanofi, multiplie par cinq le risque de troubles du développement
  • France – Grippe: 60% des pharmaciens en rupture de stock de vaccins
  • France – Le LET engage une démarche « article 51 » pour élargir les modalités de remboursement de la téléconsultation
  • Europe – MD et EPI : comment les mettre légalement sur le marché dans le cadre du COVID-19
  • Africa – Journée mondiale de l’Afrique: 10 initiatives africaines face au coronavirus
  • International – « Le pire est à venir » selon le directeur général de l’OMS
  • Europe – Oxygène à 98 pour cent : pour mieux répondre aux besoins, la Ph. Eur. lance une consultation publique sur une nouvelle qualité d’oxygène
  • France – COVID-19 : les mesures actuelles sont-elles suffisantes ?
  • Europe – Brexit: Council adopts decision to conclude the withdrawal agreement
  • France – Prix du médicament : le PLFSS 2020 innove
  • France – Un médicament anti-calvitie pointé du doigt pour des risques de troubles sexuels
  • France – Comment apparier des données cliniques avec les données du SNDS ?
  • France – ANSM – Nominations : Décision n° 2018-216 du 28/09/2018
  • Bonjour tout le monde !
• Category: Médicaments
  • USA – Califf: FDA committed to boosting complex generic drug development
  • USA – Prenatal cannabis exposure associated with mental disorders in children that persist into early adolescence
  • UK – MSD’s pembrolizumab therapy gets NICE approval
  • International – Genetically modified herpes combats advanced cancers
  • Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants
  • Europe – Biosimilar medicines can be interchanged
  • Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection
  • Europe – EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
  • USA – FDA issues final rule on ‘right to try’ reporting requirements
  • USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
  • India – Indian Pharmacopoeia joins global discussion group pilot
  • USA – FDA issues guidance documents on labeling drug identity, constituents
  • USA – FDA finalizes guidance on submitting RWD/RWE in application cover letters
  • Europe – Annex 1 implementation strategies: Experts say manufacturers must grapple with PUPSIT
  • Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
  • UK – MHRA launches new conflicts of interest code of practice for independent advisors
  • USA – Groups weigh in on FDA’s licensing rules for 3PLs and distributors
  • USA – Industry experts tout potential for master protocols in pediatric clinical trials
  • USA – FDA issues emergency guidance to spur development of monkeypox tests
  • USA – FDA drafts guidance on pediatric clinical pharmacology studies
  • Europe – COVID-19 vaccines safety update
  • UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment
  • Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for control of bacterial endotoxins in its water monographs
  • Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products
  • Europe – New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European Pharmacopoeia
  • Europe – 11th edition of the European Pharmacopoeia now available in print
  • Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
  • UK – Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE
  • USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
  • Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
  • USA – House report finds Trump officials sought to influence FDA during COVID pandemic
  • USA – FDA allows sponsors to spread out costs in revised IND charging guidance
  • USA – FDA approves durvalumab for locally advanced or metastatic biliary tract cancer
  • Europe – New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone
  • Europe – Review of pholcodine medicines started
  • Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing potential
  • Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
  • USA – FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines
  • Europe – EU issues long-awaited GMP Annex 1 revision
  • Europe – Patient registries: EMA officials highlight opportunities in orphan drug development
  • Europe – EMA accepts application for leukaemia drug from Otsuka and Astex
  • USA – European, US guidance differs on API nitrosamines
  • Asia – 3D-printed drug advancing to clinical trials in SE Asia
  • USA – Patients with incurable cancer should be included in trials for new therapies
  • USA – FDA issues final guidance on ANDA CRL, Orange Book
  • USA – FDA final guidance targets neonatal pharmacology studies
  • Europe – EMA reviewing data on sabizabulin for COVID-19
  • USA – FDA guidance focuses on Real-Time Oncology Review program
  • USA – FDA describes plans to expand remote regulatory assessments
  • Europe – EMA recommends restricting use of cancer medicine Rubraca
  • Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
  • USA – FDA offers new guidance on therapeutic equivalence evaluations
  • USA – FDA guidance targets dose banding information in drug labels
  • Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
  • Europe – Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
  • Europe – ICH Guideline M12 on drug interaction studies
  • UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark MHRA reclassification
  • USA – Industry asks FDA to expand scope of product quality assessment guidance
  • France – HAS : Agrément des Bases de données sur les Médicaments
  • UK – NICE recommends Rhythm Pharmaceuticals’ Imcivree for severe obesity and hyperphagia
  • USA – Legislation could catalyze EU pharma industry innovation
  • Europe – EC authorisation granted to kidney disease treatment Kinpeygo
  • Europe – EMA validates application for Byondis’ trastuzumab duocarmazine
  • UK – Bristol Myers Squibb’s Opdivo recommended by NICE for malignant pleural mesothelioma patients
  • UK – NICE recommends Novartis’ Piqray in combination with Faslodex for advanced breast cancer patients
  • Europe – EMA re-elected as chair of ICMRA from October 2022
  • USA – Guidance : Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products
  • USA – HHS issues guidance on legally prescribed drugs for abortion
  • Europe – EMA launches pilot project on analysis of raw data from clinical trials
  • Europe – ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
  • Europe – Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
  • Europe – Further measures to identify and address medicine shortages during public health emergencies adopted
  • Uk – NICE recommend’s use of Leo Pharma’s Adtralza
  • Italy – The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
  • Europe – Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
  • USA – FDA offers guidance on fit-for-purpose clinical outcome assessments
  • France – Rapport d’activité 2021 de la HAS
  • Europe – Global regulators agree on key principles on adapting vaccines to tackle virus variants
  • UK – NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia
  • Europe – EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate
  • UK – NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis
  • France – Topiramate : risque de troubles neurodéveloppementaux chez les enfants exposés in utero et rappel des règles d’utilisation chez les femmes
  • Europe – Possible use of the vaccine Jynneos against infection by monkeypox virus
  • Europe – Monkeypox: EMA starts review for Imvanex
  • USA – FDA releases 5-year action plan to combat neurodegenerative diseases
  • France – Accès précoce et compassionnel: les deux nouveaux référentiels de la Cnil attendus en septembre
  • USA – FDA explains when it will rescind breakthrough designations
  • Europe – First gene therapy to treat severe haemophilia A
  • Europe – EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
  • Europe – EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
  • UK – NICE opts to reject Acorda’s MS drug Fampyra
  • USA – Draft guidance outlines FDA’s testing requirements for tissue containment systems
  • USA – Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver
  • USA – FDA to form task force, public-private partnership on rare neurodegenerative diseases
  • France – Covid-19 : l’Agence européenne des médicaments autorise la mise sur le marché du vaccin de Valneva
  • France – Médicament: ouverture d’une plateforme de dépôt de dossiers auprès du CEPS
  • France – HAS : Monkeypox : la stratégie vaccinale réactive précisée pour les primo-vaccinés et les enfants
  • Europe – Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
  • Europe – EMA Management Board: highlights of June 2022 meeting
  • USA – FDA authorizes Pfizer, Moderna vaccines for youngest children
  • Europe – Start of rolling review for adapted Spikevax COVID-19 vaccine
  • UK – NICE recommends Eli Lilly’s breast cancer therapy
  • UK – Genedrive genetic variant test for infants evaluated by NICE
  • UK – MHRA joins international partnerships to set global standards for medicines and medical devices regulation
  • Europe – Start of rolling review for adapted Comirnaty COVID-19 vaccine
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022
  • Europe – EMA recommends withdrawal of marketing authorisation for amfepramone medicines
  • France – Intérêt du logiciel doté d’IA « PharmaClass » pour aider le pharmacien clinicien à sécuriser la prise en charge médicamenteuse
  • Europe – EMA : Complex clinical trials – Questions and answers
  • Europe – EMA publishes annual report 2021
  • UK – NICE recommends Vazkepa for patients at risk of stroke and heart attacks in England and Wales
  • USA – Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests
  • Europe – EMA adopts first list of critical medicines for COVID-19
  • USA – Cavazzoni: Pandemic-era tools, learnings are here to stay
  • India – Indian pharma to focus on quality to remain a world leader
  • Europe – EU regulators offer new guidance on complex clinical trials
  • USA – FDA withdraws cancer drug approval after finding possible higher death rates
  • UK – NICE recommends UCB’s Fintepla for Dravet syndrome
  • UK – NICE approves Merck’s Keytruda for adult patients with rare triple negative breast cancer
  • USA – FDA officials reflect on quality maturity model, quality metrics
  • UK – NICE recommends Roche’s faricimab (Vabysmo) as a treatment option for two leading forms of sight loss
  • Europe – Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
  • Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
  • UK – NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC
  • USA – Medtech groups want more time to implement FDA’s QMSR rule
  • USA – FDA issues Q&A on importation of prescription drugs from Canada
  • France – Lyon: ouverture d’un centre spécialisé dans la prise en charge des addictions aux médicaments
  • USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
  • Europe – EMA medical terms simplifier
  • International – Pfizer/BioNTech vaccine effective against Omicron in children five and under
  • Europe – Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements.
  • Europe – Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
  • Europe – EMA guidance supports development of new antibiotics
  • USA – Les Etats-Unis se dirigent vers la vaccination des cas contacts contre la variole du singe
  • UK – G7 health ministers unite to protect world from another pandemic
  • USA – FDA asks manufacturers to develop risk management plans to avert shortages
  • Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
  • Europe – Synchron Research Service: suspension of medicines over flawed studies
  • Europe – First therapy to treat rare genetic nervous system disorder AADC deficiency
  • Europe – First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes)
  • Europe – EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine
  • UK – NICE recommends app-based treatment for insomnia over sleeping pills
  • Canada – Update : Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format
  • USA – FDA updates guidance on evaluating out-of-specification results for drugs
  • UK – MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment
  • UK – COVID-19 vaccine study focuses on young and immunosuppressed
  • France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs
  • UK – NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer
  • USA – FDA works to advance real-world data collection in pregnancy and lactation
  • Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe
  • UK – NICE draft final guidance for Gedeon Richter UK’s new uterine fibroids treatment
  • USA – FDA guidance explains benefit-risk approach for quality assessments
  • USA – FDA launches program to speed up rare disease drug development
  • Europe – COVID-19 vaccines safety update
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
  • Europe – Rules of procedure of the Emergency Task Force (ETF)
  • Europe – EMA updates annexes on procedures for running GCP inspections
  • USA – FDA offers insight into product quality assessment principles
  • USA – FDA sheds light on conducting human radiolabeled mass balance studies
  • Europe – EMA starts review of cancer medicine Rubraca
  • International – Pherecydes Pharma : autorisation d’un 1er traitement compassionnel avec ses phages à l’international
  • USA – FDA officials: ‘New normal’ may include annual COVID vaccination
  • Europe – Nouvelles règles européennes sur le devoir de vigilance
  • USA – FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease
  • France – Covid-19 : la HAS élargit l’autorisation d’accès précoce accordée à Evusheld®
  • Uk – NICE recommend exercise over painkillers for arthritis pain
  • UK – Scientists to trial world-first long-acting injection for high blood pressure
  • USA – FDA finalizes electronic postmarketing safety reporting guidance
  • France – Covid-19 : la HAS se prononce en faveur du remboursement du Paxlovid®
  • USA – FDA finalizes guidance for drugs and biologics containing nanomaterials
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
  • Europe – Facilitating global access to diabetes treatments for non-EU patients
  • Europe – Euro Roundup
  • USA – Extrapolation of drug indications from study populations by FDA is ‘common’
  • UK – NICE releases revised guidelines on antidepressants
  • UK – Guidance : Pregabalin and risks in pregnancy
  • USA – Industry guidance aims to help manufacturers adhere to bar coding requirements
  • USA – Celiac disease: FDA offers guidance on drug development
  • USA – FDA offers guidance on waiver requests for pH adjusters
  • USA – FDA finalizes guidance on drug bioavailability studies
  • UK – MHRA approves the Moderna COVID-19 vaccine ‘Spikevax’ for use in 6 to 11-year olds
  • UK – NICE recommends Merck’s Tepmetko for lung cancer treatment
  • UK – Valneva COVID-19 vaccine approved by MHRA
  • USA – FDA recommends sponsors plan to include race, ethnicity in clinical trial design
  • Europe – Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trials
  • USA – FDA offers guidance on waiver requests for pH adjusters
  • Europe – COVID-19 vaccines safety update
  • Europe – EMA and the EUnetHTA 21 consortium set priorities for their collaboration
  • USA – FDA proposes rating system for pharmaceutical QMM
  • USA – FDA finalizes guidance for hepatitis B drug development
  • Canada – Special Access Program for drugs: Guidance document for industry and practitioners
  • UK – NICE overturns previous decision, recommends Merck and Pfizer’s Bavencio
  • USA – The FDA Sets Up QR Codes for Pharmaceutical Product Electronic Certificates
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
  • UK – NICE recommends Koselugo for the treatment of neurofibromatosis type 1
  • Europe – ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
  • International – ICH guideline E11A on pediatric extrapolation
  • USA – FDA delays Merck’s pneumococcal vaccine Vaxneuvance
  • USA – Alzheimer’s disease: FDA guidance had ‘strong influence’ on endpoint selection
  • UK – Guidance for people whose immune system means they are at higher risk
  • USA – USP: Supply chain experts tackle supply chain resiliency
  • Europe – MedTech Europe updates ethical code
  • France – Dominique Le Guludec nomme Fabienne Bartoli comme directrice générale
  • UK – The IMC unites health industry professionals to combat antibiotic resistant infections
  • UK – Amgen and UCB’s Evenity recommended by NICE for severe osteoporosis
  • Europe – EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • Europe – Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
  • USA – FDA authorizes second round of mRNA boosters for older and immunocompromised people
  • Europe – EU recommendations for 2022-2023 seasonal flu vaccine composition
  • Europe – EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
  • USA – Inspections emerge as flashpoint in BsUFA II assessment meeting
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
  • Europe – New gene therapy to treat adult patients with multiple myeloma
  • Europe – EMA recommends authorisation of COVID-19 medicine Evusheld
  • USA – FDA shifts classification of some ophthalmic products to comply with Genus decision
  • Europe – Exigences de qualité pour les nanomédicaments : quel rôle pour la Pharmacopée Européenne ?
  • Europe – PROCOVA™ Handbook for the Target Trial Statistician
  • USA – USP supply chain map provides ‘early warning’ of possible drug shortages
  • UK – NICE recommends Biomarin’s Vimizim for patients with rare life-limiting metabolic disorder
  • USA – Moderna applies to FDA for authorisation for second COVID-19 booster shot for all adults
  • USA – FDA approves drug for treatment of seizures associated with rare disease in patients two years of age and older
  • Europe – Guidance on parallel EMA/EUnetHTA 21 Joint Scientific Consultation
  • Europe – Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections
  • Europe – EMA Management Board: highlights of March 2022 meeting
  • Europe – COVID-19 vaccines safety update
  • USA – FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections
  • UK – NICE to improve diagnosis for foetal alcohol spectrum disorder
  • USA – First generic of popular inhaler approved
  • Europe – Drug industry says EMA’s PRIME scheme useful but could be improved
  • Europe – Guideline on good pharmacovigilance practices (GVP)
  • USA – NIH launches clinical trial of three mRNA HIV vaccines
  • USA – FDA offers guidance on drug verification requests
  • International – Pfizer highlights need for fourth dose of COVID-19 vaccine to FDA
  • USA – Quality metrics: FDA wants feedback on pared-down program
  • Europe – COVID-19: Council agrees to extend the Regulation establishing the EU Digital COVID Certificate
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
  • Europe – Council gives green light to start negotiations on international pandemic treaty
  • International – ORGANOIDES : Néovacs investit dans NETRI et enrichit son portefeuille de participations dans des biotech françaises prometteuses
  • Europe – L’évaluation des technologies de santé au niveau européen : le Règlement tant attendu a été adopté et publié
  • USA – This Week at FDA: HHS delays SUNSET rule, FDA begins release of Comirnaty review docs, and more
  • USA – FDA calls on firms to be ‘recall ready’ in final guidance
  • USA – FDA finalizes guidance on pre-launch drug import policy
  • Europe – PRIME enables earlier availability of life-changing medicines
  • Europe – PRIME : Analysis of the first 5 years’ experience
  • UK – First RSV vaccine trial for infants offers significant results
  • UK – Previously untreatable lung cancer patients offered new therapy
  • Canada – Updated guidance: Applications for COVID-19 drug clinical trials under the Regulations
  • USA – Comments on RWD registry guidance focus on harmonization, need for details
  • Europe – Update of application forms for Certificate of Suitability applications
  • USA – FDA finalizes three guidances on cancer trials in line with Biden’s ‘Moonshot’
  • Europe – Regulation on EMA’s extended mandate becomes applicable
  • USA – USP seeks input on mRNA analytical testing guide
  • Europe – European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance
  • UK – Seagen’s Tukysa granted NICE recommendation for breast cancer patients
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
  • Europe – Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
  • Europe – New medicine for rare type of eye cancer
  • Europe – EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
  • Europe – EMA recommends approval of Spikevax for children aged 6 to 11
  • UK – NICE recommends GSK’s Zejula for patients with ovarian cancer
  • UK – London High Court rules in favour of NHS in Servier drug dispute
  • Europe – EudraVigilance – EVWEB User Manual Version 1.6
  • Europe – Inspections à distance de l’EDQM : de phase pilote à dispositif permanent du programme d’inspection
  • Europe – European medicines regulatory network adopts EU common standard for electronic product information
  • Europe – EMA : Human medicines: highlights of 2021
  • France – Covid-19 : la HAS rend trois nouveaux avis pour actualiser la stratégie de lutte contre le virus
  • France – Médicament: la Cnil lance une consultation sur deux référentiels relatifs aux accès précoce et compassionnel
  • France – Production et culture du cannabis à usage médical en France : l’ANSM engage les travaux pour définir les spécifications des médicaments à base de cannabis
  • USA – FDA’s KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q Revision
  • USA – FDA releases 43 new and revised product-specific guidances
  • USA – Industry wants FDA to align visible particle classifications and inspections with USP
  • USA – Generic drug approvals continued to fall in 2021
  • Europe – IRIS guide to registration and RPIs
  • Europe – Ph. Eur. Commission adopts harmonised general chapter 2.2.46. Chromatographic separation techniques Back
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 February 2022
  • Europe – EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
  • Europe – PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
  • USA – FDA urges sponsors to find alternatives to nonhuman primates for toxicity studies
  • USA – FDA would rather not have to review ‘sanitation tunnels’ for COVID
  • USA – Opioid alternatives: FDA offers insights on developing non-addictive drugs for acute pain
  • USA – FDA offers insights on blood pressure studies, immunogenicity labeling
  • Europe – Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU
  • USA – FDA issues clinical pharmacology draft guidance for antibody-drug conjugates
  • Europe – EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
  • Europe – EMA offers more clarity on controlling multiple nitrosamines
  • USA – CDER unveils 30 new planned guidance documents in 2022 agenda
  • UK – Not so NICE: cancer patients miss out on innovative new treatments
  • Europe – Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg)
  • International – Omicron hospitalization risk higher among unvaccinated
  • USA – FDA rescinds approval of 29 new drug applications
  • USA – Dosing begins in mRNA HIV vaccine trial
  • UK – NHS to roll out life-saving gene therapy for rare disease affecting babies
  • USA – FDA finalizes population pharmacokinetics guidance
  • USA – FDA issues long-awaited licensing rules for drug distributors and 3PLs
  • UK – Risk-Adapted Approach to clinical trials and Risk Assessments
  • UK – NICE recommends AZ’s Forxiga for kidney disease
  • UK – Novavax COVID-19 vaccine Nuvaxovid approved by MHRA
  • USA – FDA drafts guidance on formal meetings with OTC sponsors
  • USA – PIC/S revises GMP guide to reflect new EU clinical trials regulation
  • USA – New FDA guidances aim to improve ANDA review process
  • USA – FDA finalizes guidance on premarket review of combination products
  • Europe – A stronger role for EMA
  • USA – FDA officials look outward to improve the expedited drug approval process
  • USA – Moderna begins phase 2 trial of Omicron-specific booster
  • Europe – New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022
  • Europe – COMP meeting report on the review of applications for orphan designation: January 2022
  • Europe – EU publishes final arrangements for new IVDR transition in official journal
  • Europe – COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
  • Australia – Artificial Intelligence Can Save Pharmacovigilance in Australia
  • USA – Indian drugmaker gets warning letter from FDA
  • USA – New FDA guidances aim to improve ANDA review process
  • Europe – L’EMA accorde une autorisation de mise sur le marché au Paxlovid et Xenothera (Xav-19) n’a pas été autorisé par l’ANSM.
  • France – Vaccins COVID-19 et troubles menstruels : pas de lien direct selon l’ANSM
  • France – Covid-19 : comment les antiviraux luttent contre l’infection au SARS-CoV-2
  • France – CBD : le Conseil d’Etat redonne de l’air à la filière
  • Europe – Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched
  • USA – Pancreatic cancer T-cell therapy gains orphan drug tag
  • UK – New proposals for the future of UK clinical trial legislation
  • Switzerland – COVID-19 patch vaccine trial launched
  • USA – FDA could authorize COVID-19 vaccine for youths under 5 next month
  • USA – FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
  • USA – FDA outlines rules for ‘portions’ of official samples in draft Q&A guidance
  • Europe – European Parliament endorses legislation bolstering EU’s ability to tackle shortages
  • France – Covid-19 : accès précoce accordé au Paxlovid® en traitement curatif
  • Europe – International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
  • Europe – Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders
  • UK – NICE moves: increased accessibility and flexibility for health tech
  • UK – Clinical trials for medicines: authorisation assessment performance
  • Europe – COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
  • Europe – Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs
  • France – Médicaments : pourquoi Big Pharma veut sortir des produits grand public
  • Europe – Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
  • USA – This Week at FDA: User fee update, Califf nomination…
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 13 January 2022
  • Europe – Global regulators discuss path towards regulatory alignment on response to Omicron variant
  • Europe – European Paediatric Formulary: two draft texts released for public consultation
  • USA – Industry seeks delay for reporting manufacturing volume data
  • Europe – Commission Implementing Regluation (EU) 2022/20
  • USA – Pfizer already making Omicron-specific COVID-19 vaccine
  • China – Experts suggest new method for assessing imported generic drugs in China
  • Europe – European Commission approves cystic fibrosis treatment for six to 11-year-olds
  • Europe – Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
  • USA – Manufacturers object to provisions in FDA’s microbiological quality guidance
  • Europe – EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
  • UK – The NICE recommends Rinvoq for psoriatic arthritis patients
  • Europe – Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29) in Pharmeuropa 34.1
  • USA – FDA’s drug volume reporting requirements face pushback
  • USA – FDA approved more first-in-class drugs, gave more accelerated approvals in 2021
  • France – Covid-19 : accès précoce accordé au Xevudy® en traitement curatif
  • UK – NICE recommends MSD’s Keytruda in combination with chemotherapy for routine treatment of lung cancer
  • Canada – Special Access Program for drugs: Guidance document for industry and practitioners
  • USA – Digital health tech in clinical investigations: FDA issues draft guidance
  • USA – FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies
  • Europe – Pharmeuropa 34.1 just released
  • France – Dépakine : Sanofi jugé responsable d’un manque de vigilance et d’information sur les risques
  • UK – MHRA grants approval for Pfizer’s oral COVID-19 antiviral pill
  • Europe – Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines
  • UK – The past, the present, and the future of clinical trials transparency in the UK
  • France – Arrêté du 25 octobre 2021 fixant le règlement intérieur type des CPP
  • USA – Pfizer COVID-19 pill garners FDA authorization
  • USA – NIH celebrates FDA approval of long-acting injectable drug for HIV prevention
  • Europe – BSP study outcomes published in Pharmeuropa Bio & Scientific Notes
  • Europe – Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
  • Europe – All you ever wanted to know about Ph. Eur. procedure 4 but never dared ask!
  • Europe – Liposomal amphotericin B product-specific bioequivalence guidance
  • Europe – Ursodeoxycholic acid product-specific bioequivalence guidance
  • Europe – Draft olaparib 100 mg & 150 mg film-coated tablets product-specific bioequivalence guidance
  • Europe – EMA recommends Nuvaxovid for authorisation in the EU
  • Europe – EMA and ECDC recommendations on heterologous vaccination courses against COVID-19: ‘mix-and-match’ approach can be used for both initial courses and boosters
  • Europe – EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
  • UK – NICE recommends monotherapy for adjuvant treatment of stage 3 melanoma
  • Europe – New treatment for sickle cell disease
  • USA – FDA addresses establishment of inspection programs for injectables
  • Europe – Heterologous primary and booster COVID-19 vaccination
  • Europe – Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg)
  • Europe – EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
  • France – Un référentiel unique d’interopérabilité du médicament disponible au quatrième trimestre 2022 (ANS)
  • Europe – COVID-19: EMA recommends authorisation of antibody medicine Xevudy
  • Europe – EMA recommends approval for use of Kineret in adults with COVID-19
  • UK – NICE recommend venetoclax and azacytidine for patients with aggressive blood cancer
  • UK – Study finds Omicron multiplies 70 times faster than Delta, UK COVID-19 cases exceed 75,000
  • France – Covid-19 : deux nouveaux traitements évalués par la HAS
  • USA – Unannounced FDA inspections in India, China to begin soon
  • Europe – EMA launches the Regulatory Science Research Needs initiative
  • UK – Needle free COVID-19 vaccine trialled in UK
  • Europe – COVID-19 Vaccine Janssen: EMA recommendation on booster dose
  • Europe – European Pharmacopoeia Supplement 10.8 now available
  • France – Variant Omicron: le Conseil scientifique recommande d’augmenter la dose de rappel de Moderna
  • France – Les antibiotiques sont-ils un traitement efficace contre la COVID-19 et provoquent-ils des effets indésirables ?
  • USA – FDA releases draft guidances on developing rhinosinusitis drugs, colonoscopy bowel preps
  • USA – Viagra associated with reduced risk of Alzheimer’s disease
  • Europe – EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
  • USA – FDA issues final guidance on pediatric anti-infective development
  • UK – Five-drug combination for ultra-high-risk bone marrow cancer identified
  • Switzerrland – Covid-19 : la Suisse travaille sur quatre médicaments
  • Europe – EMA : COVID-19 vaccine safety update Janssen
  • USA – Pharma, device groups oppose FDA’s planned drug to device transition
  • France – Décision n° 2021.0312/DC/SEM du 9 décembre 2021 du collège de la Haute Autorité de santé portant autorisation d’accès précoce de la spécialité EVUSHELD (tixagévimab/cilgavimab)
  • USA – FDA approves first pre-exposure prophylactic against COVID-19
  • Europe – EMA : COVID-19 vaccine safety update Spikevax
  • Europe – EMA : COVID-19 vaccine safety update Comirnaty
  • Europe – EMA : COVID-19 vaccine safety update Vaxzevria
  • USA – FDA guidance targets CMC changes in biologic products
  • Europe – International regulators stress continued need for COVID-19 therapeutics
  • UK – NICE publish final guidance recommending Aspaveli in adults with ultra-rare blood disorder
  • USA – FDA issues draft guidance on study designs using real-world data
  • UK – Omicron rise prompts tougher measures in England
  • USA – Consensus lacking on ‘value’ for new anticancer drugs
  • Europe – Formulaire pédiatrique européen : deux projets de textes publiés pour enquête publique
  • France – Vente en ligne de médicament: la France fait appliquer ses règles aux sociétés européennes
  • USA – FDA rolls out more guidance on ‘N of 1’ gene therapies
  • Europe – EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns
  • Europe – EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
  • Europe – EMA recommends approval for use of RoActemra in adults with severe COVID-19
  • USA – FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021
  • USA – FDA announces FY 2022 GDUFA science and research priorities
  • UK – MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and death by 79%
  • Europe – EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
  • Europe – New reports address generics pricing, innovation in the EU
  • Europe – EU official says ICH Q6B is outdated and needs revision
  • USA – US regulators set to approve oral antiviral against COVID-19
  • International – COVID-19 vaccines against Omicron may be fast-tracked
  • USA – FDA offers draft guidance for registries as RWD
  • UK – COVID-19 vaccines safe for pregnant women
  • USA – First trial of a vaccine against Alzheimer’s launches
  • Europe – Évolution des délais de traitement des demandes de CEP par l’EDQM
  • Europe – Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
  • Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
  • Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
  • Europe – EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
  • UK – NICE approves hormone drug which could prevent 1,200 miscarriages each year
  • Europe – A vision for use of real-world evidence in EU medicines regulation
  • USA – FDA suggests alternative approaches for nitrosamine risk assessments
  • USA – FDA shares research to improve dose selection in pediatric drug development
  • Europe – EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19
  • UK – NICE recommends risdiplam for spinal muscular atrophy
  • USA – GAO: Pathway for antimicrobial drug development leads to few approvals
  • Europe – PRAC recommendations on signals 25-28 October 2021 PRAC meeting
  • UK – UK’s NICE recommends Roche’s Evrysdi
  • Europe – EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
  • France – Didier Raoult accusé de fraude par ses équipes sur l’hydroxychloroquine
  • Europe – Euro Roundup: EFPIA calls for EU to drive reform of WTO, shares feedback on emergency authority
  • USA – FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism
  • Europe – EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
  • Europe – EMA starts review of Paxlovid for treating patients with COVID-19
  • UK – NICE recommends Inrebic for rare blood cancer
  • Europe – EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
  • UK – NICE approves first long-acting jab for HIV to replace daily pills
  • Switzerland – COVID-19 vaccine for children aged 6 to 11: Moderna submits application for indication extension
  • USA – FDA urged to endorse EPCIS to spur manufacturers’ uptake of DSCSA
  • Europe – EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
  • Europe – Pharmeuropa 33.4 just released
  • UK – UK disposed of 600,000 AZ vaccine doses after they passed expiry date
  • Europe – EDQM Laboratory’s ISO 17025:2017 accreditation renewed
  • Europe – Forxiga (dapagliflozin) 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus
  • UK – NICE recommends cenobamate for treatment of adult epilepsy patients in UK
  • USA – Study: RWD not ready for postapproval prime time
  • USA – FDA: Biosimilar program a success, but challenges remain
  • USA – COVID-19 therapeutics tracker
  • Europe – First-in-class medicine recommended for treatment of rare blood vessel inflammation
  • UK – NICE ‘no’ for BioMarin’s Vimizin
  • UK – New drug combination highly effective in children with leukaemia
  • UK – New COVID-19 vaccines could target replication proteins
  • Europe – Euro Roundup: EU extends scope of guideline on clinical trials with genetically modified human cells
  • Europe – COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
  • Europe – ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticals
  • Europe – ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products – Step 2b
  • UK – Updated guidelines for managing long-term effects of COVID-19 published
  • UK – University of Oxford begins human trials of Ebola vaccine
  • Europe – EMA : Covid-19 vaccine safety update – Spikevax
  • Europe – EMA : Covid-19 vaccine safety update – Vaxzevria
  • Europe – EMA : Covid-19 vaccine safety update – Comirnaty
  • Europe – EMA : Covid-19 vaccine safety update – Janssen
  • USA – Industry calls for technical, scope changes in ICH S12 guideline
  • Europe – EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
  • USA – White paper bolsters ctDNA as potential ‘early endpoint’ in cancer approvals
  • France – HAS : Stratégie de vaccination contre la Covid-19 – Place du vaccin à ARNm SPIKEVAX
  • Europe – COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
  • USA – FDA taking incremental approach to launching KASA reviews
  • Europe – Draft qualification opinion of Islet Autoantibodies (AAs) as Enrichment Biomarkers for Type 1 Diabetes (T1D) Prevention Clinical Trials
  • UK – UK’s MHRA approves first oral antiviral against COVID-19
  • UK – NICE issues draft recommendation for new kidney disease treatment
  • UK – NICE recommends Namuscla for NHS to treat genetic disorder
  • Switzerland – AstraZeneca withdraws authorisation application for COVID-19 vaccine in Switzerland
  • USA – Pandemic has challenged industry’s implementation of DSCSA
  • USA – FDA reiterates support for semi-distributed tracing model under DSCSA
  • USA – GDUFA III commitment letter details coming changes to FDA’s generic review program
  • Europe – EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
  • USA – FDA issued vaccine EUAs without facility inspections: GAO
  • USA – Nitrosamine detection tests should be ‘fit for purpose,’ says FDA
  • Europe – EMA encourages companies to submit type I variations for 2021 in November 2021
  • Europe – Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia
  • Europe – EMA nod for excessive daytime sleepiness med Ozawade
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
  • UK – Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines
  • USA – FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases
  • Europe – Compilation of Union procedures on inspections and exchange of information
  • Europe – European Health Union: Commission establishes portfolio of 10 most promising treatments for COVID-19
  • UK – NICE does not recommend tucatinib for advanced breast cancer
  • Europe – Spikevax: EMA recommendation on booster
  • Europe – COVID-19: EMA starts rolling review of molnupiravir
  • USA – FDA drafts data standards guidance for RWD
  • USA – Moderna COVID-19 vaccine generates long-lasting immune memory
  • UK – NICE recommends gene silencing therapy for porphyria patients on NHS
  • USA – FDA okays Moderna, J&J, ‘mix and match’ boosters
  • France – Publicité et vente en ligne de médicament: l’UDGPO dénonce l’inaction des pouvoirs publics
  • Europe – EMA shares lessons learned from biosimilars pilot
  • USA – The FDA vaccine advisory board recommends booster shots of both the J&J and Moderna vaccines
  • Europe – Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders
  • Europe – EC updates Clinical Trial Regulation Q&As ahead of January go-live
  • France – Sérialisation: arbitrage ministériel en cours sur un soutien financier aux officinaux
  • USA – FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
  • Europe – EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
  • UK – NICE approves Ofev for PF-ILD
  • USA – FDA adcomm unanimous on J&J boosters for all
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021
  • UK – NICE clears Opdivo for resected oesophageal or gastro-oesophageal junction cancer
  • Europe – First-in-class medicine to treat aggressive form of breast cancer
  • Europe – European Pharmacopoeia device version to be discontinued
  • USA – Unanimous thumbs up from FDA committee for Moderna booster
  • Europe – Revised osmolality chapter for public comment in Pharmeuropa
  • Europe – COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)
  • Europe – Vaxzevria : risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding
  • Europe – EMA : Final Programming Document 2021-2023
  • Europe – EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
  • Europe – A global approach to regulatory flexibility to increase manufacturing capacity during COVID-19
  • USA – New USP chapter details lifecycle approach to analytical testing
  • USA – FDA official breaks down novel excipient pilot program
  • USA – FDA’s accelerated approval program: Is change on the way?
  • Europe – Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines
  • USA – FDA recognizes Memorial Sloan Kettering tumor variant database
  • Europe – Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa
  • Europe – EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
  • UK – NHS encourages pregnant women to get COVID-19 vaccine
  • UK – NICE backs Rinvoq for moderate active RA
  • Europe – European Union Clinical Trials Information System CTIS: Go-live Planning
  • UK – Fungus-derived cancer killing drug by Oxford University shows promise
  • UK – NICE recommends Novartis’ Adakveo for sickle cell disease
  • Europe – EMA : COVID-19 vaccine safety update : COMIRNATY
  • Europe – EMA : COVID-19 vaccine safety update : VAXZEVRIA
  • Europe – EMA : COVID-19 vaccine safety update : Janssen
  • Europe – EMA : COVID-19 vaccine safety update : Spikevax
  • UK – First subject given COVID-19 vaccine candidate in UK-based Scancell’s COVIDITY trial
  • USA – FDA seeks to update compounding guidance for hospital pharmacies
  • Europe – New guide to clinical trial lay summaries available for EU sponsors
  • Europe – Pharmeuropa 33.4 just released
  • USA – US FDA says efficacy data from 2 Indian CROs is invalid
  • USA – FDA issues guidance on NSD microbial contamination control
  • USA – FDA guidance focuses on RWD from medical claims, EHR
  • UK – MSD: Antiviral COVID-19 pill can halve the risk of hospitalisation and death
  • Europe – Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
  • Europe – EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
  • China – Clinical evaluation authority, plus guidelines for animal testing studies
  • USA – FDA drafts safety reporting guidance for drug and device investigators
  • USA – FDA draft guidance outlines criteria for conducting benefit/risk assessments
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021
  • USA – For gene therapies, FDA drafts trial guidance, finalizes « sameness » for orphan exclusivity
  • Europe – EU extends GMP, GDP certificates through 2022 as pandemic effects linger
  • Europe – European Health Union: Towards a reform of EU’s pharmaceutical legislation
  • UK – NICE recommends life-extending urothelial cancer treatment
  • USA – FDA addresses microbial contamination in non-sterile drugs
  • USA – FDA issues draft guidance on RWD sourced from EHRs, claims data
  • Europe – EMA implements new measures to minimise animal testing during medicines development
  • Europe – Risque de présence d’impuretés azoturées mutagènes dans le losartan (substance active)
  • USA – Drugs for non-TB pulmonary disease see new FDA guidance
  • USA – Pfizer to soon submit data on Covid vaccine for kids aged 5-11
  • Europe – EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
  • France – Covid-19 : la HAS précise les populations éligibles à une dose de rappel de vaccin
  • USA – FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions
  • USA – COVID-19 Pfizer/BioNTech booster approved by FDA and CDC
  • Europe – New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders
  • Europe – Vaccines Europe makes the case for vaccine-specific HTA
  • USA – FDA guidance covers frequently asked CMC questions for generic drugs
  • Europe – Use of Vaxzevria to prevent COVID-19 – Article-5(3) procedure: Final assessment report
  • UK – NHS patients gain access to COVID-19 treatment Ronapreve
  • USA – FDA finalizes more Q&As on biosimilar development
  • USA – La FDA se réorganise et crée un  »bureau de la transformation numérique »
  • UK – BioCryst’s HAE med Orladeyo wins NICE nod
  • Europe – EU “still interested” in Valneva COVID vaccine despite UK snub
  • USA – In advance of adcomm, Pfizer makes its case for Comirnaty booster
  • France – Sérialisation: des sanctions contre les officinaux récalcitrants envisagées dans le PLFSS 2022
  • UK – NICE backs Opdivo for head and neck cancer
  • UK – UK announces COVID boosters for a “bumpy winter” ahead
  • USA – Medicare could negotiate drug prices under Biden plan
  • Europe – EMA : Guidance documents
  • France – RGPD : Q & R
  • International – Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting
  • France – Publication des référentiels de certification des LAP hospitaliers et en ambulatoire (JO)
  • USA – FDA launches excipient pilot program
  • USA – FDA reaches milestone in generics approvals
  • USA – Industry calls for withdrawal of FDA electronic tracing guidance
  • Europe – HMA-EMA plans real-world metadata framework for regulatory decision-making
  • UK – NICE OKs Xeljanz for individuals with juvenile idiopathic arthritis
  • USA – FDA updates guidance on generic drug development during COVID
  • Europe – Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer
  • UK – MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
  • UK – Novavax begins COVID-19, flu combination vaccine trial
  • Europe – COVID-19 vaccine safety update : Vaxzevria
  • Europe – COVID-19 vaccine safety update : Spikevax
  • Europe – COVID-19 vaccine safety update : Comirnaty
  • Europe – COVID-19 vaccine safety update : Janssen
  • UK – Future of MHRA uncertain amid Brexit-fuelled shake up
  • UK – NICE changes its mind on Janssen’s Erleada
  • Europe – Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities
  • USA – FDA revises MAPPs on data standards program, scientific interest groups
  • USA – FDA issues updated clinical trial guidance amid pandemic
  • France – Sérialisation: les ARS somment les pharmaciens d’appliquer  »sans délai » la réglementation
  • Europe – Revised guidance for electronic submissions for CEP applications
  • Europe – Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6
  • UK – UK’s NICE recommends anti-cholesterol Leqvio for high-risk patients
  • USA – Moderna submits its COVID-19 vaccine booster to the FDA
  • UK – NICE recommends Novartis’ Cosentyx for children with severe psoriasis
  • Europe – ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
  • Asia – Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues
  • France – Lutte contre l’antibiorésistance : choix et durée de prescription des antibiotiques dans les infections bactériennes courantes
  • Europe – EMA goes all in on big data
  • International – How mRNA therapeutics are entering the monoclonal antibody field
  • USA – FDA warns public against off-label use of Pfizer vaccine
  • Europe – EMA fast-tracks Marinus Pharma’s rare epilepsy treatment
  • UK – NICE ‘no’ for Janssen’s Darzalex combo
  • USA – Cancer immunotherapy alternative dosing regimens: New FDA draft guidance
  • USA – FDA issues 39 new and revised product-specific guidances
  • USA – FDA fleshes out models for safe continuous manufacture of therapeutic proteins
  • USA – FDA Approves First COVID-19 Vaccine
  • Europe – COVID-19 vaccine safety update COMIRNATY
  • Europe – COVID-19 vaccine safety update SPIKEVAX Moderna Biotech Spain
  • Europe – COVID-19 vaccine safety update COVID-19 VACCINE JANSSEN
  • UK – NICE recommends Novartis’ Rydapt for AdvSM treatment
  • UK – First monoclonal antibody treatment for COVID-19 approved for use in the UK
  • UK – NICE’s health technology assessment methods and processes to be evaluated
  • UK – NICE recommends Eli Lilly’s breast cancer drug Verzenios
  • Europe – COVID-19 vaccine safety update VAXZEVRIA (AstraZeneca AB)
  • Europe – Artificial intelligence in medicine regulation
  • International – AZ to seek approval for « long-acting » COVID-19 antibodies
  • UK – UK approves Regeneron’s COVID-19 antibody cocktail
  • UK – New BRCA-targeting drug could treat advanced prostate cancer
  • UK – Valneva starts MHRA regulatory process for COVID-19 vaccine
  • USA – FDA refreshes bioequivalence guidance for generic drugs
  • Canada – First oral antiviral drug for COVID-19 reviewed by Health Canada
  • Europe – EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
  • International – Moderna’s COVID-19 vaccine maintains antibodies to six months, study shows
  • India – Pharmaceutical supply disruptions predicted in India
  • USA – Near-infrared guidance finalized for small molecule testing, with biologics to come
  • USA – FDA finalizes guidance on metastasis-free survival as an endpoint for prostate cancer trials
  • UK – Moderna COVID-19 vaccine approved by MHRA in 12-17 year olds
  • UK – Combined paracetamol and ibuprofen medicine approved for general sale
  • France – Covid-19 : autorisation d’accès précoce accordée à un traitement prophylactique
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
  • Europe – Clinical Trials Information System (CTIS) highlights – August 2021
  • Europe – ECDC and EMA update on COVID-19
  • UK – 16- and 17-year-olds should receive first COVID-19 vaccine, advises JCVI
  • USA – Positive Phase III results for Valneva’s chikungunya vaccine
  • Europe – Interoperability of track and trace systems: key to public health protection
  • USA – FDA finalizes long-awaited intended use rule
  • Europe – EFPIA, others question EC’s proposed orphan and pediatric drug development updates
  • USA – FDA expands use of COVID-19 antibody cocktail
  • UK – Gov’t launches study on COVID-19 vaccine dose interval for pregnant women
  • Europe – New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products
  • UK – UCB’s bimekizumab issued NICE recommendation for severe plaque psoriasis
  • Europe – Six-month countdown to go-live for the Clinical Trials Information System (CTIS)
  • Europe – Increased manufacturing capacity and supply for Spikevax
  • USA – Updated: FDA grants industry 30-day extension to comment on track and trace guidance
  • Europe – Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.
  • UK – NICE publishes ‘rapid’ guideline on rare blood clots associated with COVID-19 jab
  • France – En France, les prescriptions médicamenteuses chez les enfants se maintiennent à des niveaux élevés
  • Europe – EMA updates reflection paper on GMP responsibilities of marketing authorization holders
  • USA – FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
  • USA – FDA sets deadline for study data technical rejection criteria
  • USA – FDA’s revised MAPP outlines procedures for generic drug labeling changes
  • International – J&J and Pfizer quietly resolve Remicade biosimilar lawsuit
  • Europe – Statistical methodology for the comparative assessment of quality attributes in drug development
  • UK – NICE publishes new draft guideline covering rehabilitation after traumatic injury
  • USA – FDA seeks comments on regulation of kratom, 6 other drugs
  • USA – FDA declines to extend nitrosamine risk assessment deadline
  • Europe – Guideline on quality documentation for medicinal products when used with a medical device
  • Europe – EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
  • Australia – TGA international engagement strategy 2021-2025
  • Europe – COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021
  • Europe – CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer
  • UK – NICE, PHE publish new antimicrobial prescribing guideline on C. difficile infection
  • Europe – Notifying a change of marketing status (Update)
  • Europe – Euro Roundup
  • Europe – COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
  • USA – FDA unveils final guidance on field alert reports
  • UK – NICE recommends Incyte’s Pemazyre for rare bile duct cancer
  • UK – Ledaga recommended by NICE for rare type of lymphoma
  • UK – NICE’s decision not to approve Zytiga ‘frustrating’, says ICR
  • Europe – EMA starts rolling review of COVID-19 vaccine Vidprevtyn
  • Europe – COVID-19 treatments: under evaluation
  • Europe – EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
  • USA – Industry consortium releases blueprint for DSCSA tracking systems
  • Europe – European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting (April 2021)
  • France – Covid-19 : l’obligation vaccinale prévue par la loi est justifiée et son élargissement doit être débattu
  • UK – Combined review to facilitate speedier set up for clinical research trials
  • International – International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines
  • Europe – CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3
  • Europe – Covid-19 vaccine safety update : Spikevax
  • Europe – Covid-19 vaccine safety update : Janssen
  • Europe – Covid-19 vaccine safety update : Vaxzevria
  • Europe – Covid-19 vaccine safety update : Comirnaty
  • France – Un décret encadre l’échange de données de santé issues du DMP entre la France et des Etats de l’UE
  • USA – US FDA guidelines for remote inspections of drug facilities: Implications for life sciences companies
  • Europe – EMA and ECDC update on COVID-19
  • USA – FDA sees different tactics were successful in established conditions pilot
  • Asia – Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies
  • Europe – EMA guidelines highlight changes to IMPs triggering notification to regulators
  • Europe – Implementation of the European Pharmacopoeia Supplement 10.6 – Notification for CEP holders
  • USA – CBER Q&A addresses stem cell enforcement questions
  • Europe – New monograph on a single-source anti-TNF-alpha monoclonal antibody released for public consultation in Pharmeuropa
  • France – Données de vie réelle: un potentiel reconnu pour l’évaluation des produits de santé, des biais en embuscade (Afcros)
  • China – China announces new guidelines for oncology drugmakers
  • France – Accès précoce à un médicament
  • USA – FDA approves 29 new drugs so far this year
  • USA – Pfizer, BioNTech eye US approval for COVID-19 booster dose
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021
  • Europe – EMA finds no evidence linking viral vector in Zynteglo to blood cancer
  • Europe – Consideration on core requirements for PSURs of COVID-19 vaccines
  • Europe – Revised general chapter 5.21 Chemometric methods applied to analytical data published for public comment in Pharmeuropa
  • Europe – Euro Roundup
  • USA – FDA calls for new warning labels on hydroxyethyl starch products
  • Europe – EMA updates Q&A on nitrosamine assessment and testing
  • International – Moderna launches phase 1/2 study of mRNA-based flu vaccine
  • UK – REACT-1 study of coronavirus transmission: June 2021 interim results
  • USA – FDA finalizes guidance on studying CNS metastases in cancer trials
  • Europe – Highlights of 2020 – EDQM annual report now available
  • UK – Freedom of Information responses from the MHRA – week commencing 3 May 2021
  • France – Décision n° 2021.0169/DC/SEVOQSS du 24 juin 2021 du collège de la Haute Autorité de santé portant adoption du document Flash Sécurité Patient intitulé « Accidents liés à un médicament à risque : Qui dit potassium (KCl), dit vigilance maximale »
  • Europe – EDQM fertility preservation guide now available
  • Europe – Pharmeuropa 33.3 just released
  • USA – Guidance : Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
  • USA – FDA report examines use of patient experience data in decision-making
  • Europe – EDQM “RTEMIS” pilot project: real-time remote GMP inspections of API manufacturers
  • USA – FDA issues draft guidance for transdermal adhesion systems
  • Europe – Outcome of the 170th session of the European Pharmacopoeia Commission, June 2021
  • USA – FDA issues final guidance on providing regulatory submissions in alternate electronic formats
  • Europe – Cambridge University scientists identify 160 new drugs with COVID-19 repurposing potential
  • USA – FDA studies: No post-ingestion NDMA from ranitidine
  • Europe – Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
  • Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
  • Europe – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
  • Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
  • Europe – Scientific recommendations on classification of advanced therapy medicinal products
  • Europe – Conseil et Parlement Européen : projet de renforcement du rôle de l’EMA relatif aux médicaments et DM
  • Europe – EC issues first COVID therapeutics portfolio
  • USA – Single-shot COVID-19 vaccine produces immune response against variants
  • Europe – Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes
  • USA – FDA releases new draft guidance on sponsor role for safety reporting requirements
  • Europe – L’essai des pyrogènes sur lapin bientôt supprimé de la Pharmacopée Européenne
  • Europe – Update : Consideration on core requirements for RMPs of COVID19 vaccines
  • Europe – Update of EU recommendations for 2021–2022 seasonal flu vaccine composition
  • Europe – Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus
  • Europe – EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021
  • Europe – First cell-based gene therapy to treat adult patients with multiple myeloma
  • Europe – New treatment for people with dwarfism
  • USA – FDA calls for inclusion of patients with incurable cancers in oncology trials
  • Europe – Le GDP déploie des efforts afin d’impliquer d’autres pharmacopées de l’ICH dans le maintien à jour des annexes du guideline ICH Q4B
  • USA – NIH begins study of COVID-19 vaccination during pregnancy and postpartum
  • Europe – Clinical Trials Information System (CTIS) highlights – June 2021
  • Europe – Health Technology Assessment: Informal deal between Council and European Parliament
  • USA – Final FDA guidance targets biological product changes
  • USA – Guidance : Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
  • Europe – Questions and answers on labelling flexibilities for COVID19 vaccines
  • Europe – COVID-19 vaccine safety update : VAXZEVRIA
  • Europe – COVID-19 vaccine safety update : COMIRNATY
  • Europe – COVID-19 vaccine safety update : JANSSEN
  • Europe – COVID-19 vaccine safety update : MODERNA
  • Europe – Disappointing results from CureVac’s COVID-19 vaccine as phase 2/3 study shows only 47% efficacy
  • UK – Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses
  • UK – Regeneron’s COVID-19 drug boosts survival in hospitalised patients lacking antibodies
  • USA – Best practices and education for probiotics amid regulatory uncertainty
  • USA – FDA approves weight management drug for patients aged 12 and older
  • Europe – Consideration on core requirements for RMPs of COVID-19 vaccines
  • Europe – La Commission économique eurasienne et l’EDQM conviennent d’étendre et de renforcer la collaboration internationale en matière de circulation des médicaments
  • USA – FDA launches global Generic Drug Cluster
  • Europe – Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID
  • Europe – EMA : Annual report 2020 published
  • Europe – COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021
  • Europe – Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
  • Europe – COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
  • Canada – Release of Draft (Step 2) ICH Guidance: S1B(R1): Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals
  • Canada – Release of ICH Q3C(R8): Impurities: Guideline for Residual Solvents
  • USA – US to donate 500 million Pfizer/BioNTech COVID-19 vaccine doses through COVAX
  • USA – Allegations of fraud levied at COVID-19 vaccine maker
  • USA – FDA releases draft guidance on assessment of PROs for cancer trials
  • India – India lowers bar for approval of COVID-19 vaccines already authorized overseas
  • Europe – EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
  • USA – Maladie d’Alzheimer : trois questions sur le nouveau médicament autorisé aux Etats-Unis
  • USA – FDA testing bioequivalence data assessment tool
  • USA – FDA approves weekly injectable for obesity, overweight
  • Europe – Draft EU Common Standard for electronic product information for human medicines (ePI)
  • USA – Pharmaceutical officials propose new USP harmonized chapter on visual inspections
  • USA – Smallpox antiviral approved under FDA’s Animal Rule
  • USA – FDA Grants Accelerated Approval for Alzheimer’s Drug
  • UK – ‘Indian’ variant of coronavirus now dominant strain in the UK
  • UK – NICE draft guidance does not recommend Evrysdi for SMA
  • USA – Moderna begins process for full FDA approval for COVID-19 vaccine
  • Europe – EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
  • USA – FDA details plans for DSCSA implementation in four guidances
  • USA – FDA issues new MAPP on reviewing color additives
  • Europe – Advancing international collaboration on COVID-19 real-world evidence and observational studies
  • Europe – Euro Roundup: Switzerland moves to mitigate split from EU on device regulation
  • Europe – EU regulators develop recommendations to forecast demand of medicines
  • USA – FDA provides draft guidance for enteral tube-administered drugs
  • Europe – New general chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published for public enquiry
  • Europe – Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
  • Europe – EMA : Report of the joint HMA/EMA Workshop on Artificial Intelligence in Medicines Regulation
  • Europe – EMA and EUnetHTA take stock of their cooperation
  • Europe – First COVID-19 vaccine approved for children aged 12 to 15 in EU
  • UK – One-dose Janssen COVID-19 vaccine approved by the MHRA
  • Europe – ATMP trade organizations call for GMO exemption in EU
  • Europe – Reply to open letter to ‘Doctors for COVID ethics’ concerning COVID-19 vaccines
  • Europe – COVID-19 treatments
  • Europe – Insufficient data on use of inhaled corticosteroids to treat COVID-19
  • Singapore – Singapore approves new storage condition for Pfizer COVID-19 vaccine
  • Asia – Asia-Pacific Roundup
  • USA – FDA modifies immunogenicity language in final bispecific antibody guidance
  • USA – FDA may decline new COVID vaccine EUA requests
  • UK – Levothyroxine: new prescribing advice for patients who experience symptoms on switching between different levothyroxine products
  • USA – FDA updates guidance on covariate treatment in clinical trials
  • USA – FDA clarifies deferral policy on pediatric studies for new cancer drugs
  • USA – FDA guidance spells out acceptance criteria for synthetic peptide ANDAs
  • Europe – New treatment for obesity caused by rare genetic disorders
  • UK – NICE recommends Ultomiris for NHS use in patients with rare blood disorders
  • Europe – First gene therapy to treat children with rare inherited neurological disease
  • Europe – EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021
  • Europe – First treatment for rare liver disease
  • Europe – Euro Roundup
  • UK – Pfizer/BioNTech COVID-19 vaccine shelf-life extended from 5 to 31 days, says MHRA
  • Europe – EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
  • USA – FDA releases batch of 21 product-specific guidances
  • USA – New guidance for developers of CINV prophylaxis shifts endpoints
  • Europe – Quick guide: Clinical Study Reports submission
  • Europe – 2.9.19. Particulate contamination: sub-visible particles – PDG revision of general chapter released for public consultation
  • USA – FDA clarifies potential actions when onsite inspections are infeasible
  • International – Delivering RNA therapies to brain tumors
  • International – Nanoparticle vaccine against various coronaviruses
  • USA – US FDA finalizes guidance for post-approval changes
  • France – Sérialisation: objectif 100% d’officines connectées fin 2021, syndicats et éditeurs toujours en désaccord sur le coût
  • UK – MHRA draft guidance on the licensing of biosimilar products
  • Guidance on licensing biosimilars, ATMPs and PMFs
  • Europe – New Pharmeuropa Bio & Scientific Notes article: Pertussis Toxin BRP batch 2
  • Australia – Guidance on the management of GMP compliance signals for domestic and overseas manufacturers of medicines and biologicals
  • USA – FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19
  • Europe – More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine
  • USA – Four FDA guidances related to DSCSA awaiting OMB sign-off
  • India – India’s COVID-19 crisis could lead to global drug shortages
  • France – L’ANSM a ouvert sa plateforme de déclaration en ligne des ruptures de stock de médicaments
  • France – Publication du référentiel de certification des logiciels d’aide à la prescription en ambulatoire
  • UK – Positive results for GSK/CureVac’s COVID-19 vaccine
  • UK – NICE recommends Keytruda for colorectal cancer patients with rare mutations
  • Europe – COVID-19 vaccine safety update : MODERNA
  • Europe – Signal assessment report on Embolic and Thrombotic events (SMQ) with COVID-19 Vaccine Janssen
  • Europe – COVID-19 vaccine safety update : Janssen
  • Europe – COVID-19 vaccine safety update VAXZEVRIA
  • Europe – COVID-19 vaccine safety update COMIRNATY
  • USA – FDA finalizes QIDP Q&A guidance
  • USA – FDA awards two COA grants to study neurodevelopment disorders and nephrotic syndrome
  • Europe – Additional measures to allow experts to focus on COVID-19 activities
  • Europe – Eau pour préparations injectables : version révisée publiée pour enquête publique dans Pharmeuropa
  • USA – FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
  • Europe – Adoption du chapitre Prescriptions générales révisé
  • China – China’s Sinopharm given WHO emergency use listing for COVID-19 vaccine
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
  • France – Vaccin Covid: premières injections de Moderna en pharmacie le 28 mai, selon des syndicats
  • Europe – EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
  • Europe – International regulators and WHO call for wider public access to clinical data
  • Europe – EMA : COVID-19 vaccines
  • Europe – New policy for the development of monographs on medicinal products containing chemically defined active substance salts or bases/acids
  • USA – Pharma groups slam US decision to support COVID-19 vaccine patent waivers
  • Europe – Coronavirus: Commission proposes EU Strategy for the development and availability of therapeutics
  • UK – Guidance on the licensing of biosimilar products
  • Europe – Confidentiality arrangement between EU and Brazilian regulatory authorities
  • Europe – Euro Roundup: EU committee publishes pharmaceutical strategy draft
  • USA – FDA welcomes alternative approaches to generic drug development
  • Europe – CAT monthly report of application procedures, guidelines and related documents on advanced therapies
  • Europe – EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated
  • Europe – IMWP monographs on Favipiravir and on Favipiravir tablets published for public enquiry
  • Europe – New policy for the development of monographs on medicinal products containing chemically defined active substance salts or bases/acids
  • UK – Urine test detects aggressive forms of prostate cancer
  • Europe – Essais cliniques: le portail et la base de données européens sont « pleinement fonctionnels » (EMA)
  • Europe – EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
  • USA – FDA revokes policy issued by Trump administration
  • USA – FDA guidance says sponsors should provide ‘convincing’ proof of concept data to support INDs for individualized medicine
  • Europe – EMA clarifies application of GMP principles to ATMP starting materials
  • Europe – EMA PRIME status granted for Vertex, CRISPR Therapeutics’ gene therapy CTX001
  • UK – NICE updates guideline on atrial fibrillation
  • Europe – EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
  • Europe – AstraZeneca’s COVID-19 vaccine: benefits and risks in context
  • USA – FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose
  • Europe – EMA to issue electronic certificates for medicines
  • Europe – EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
  • Europe – COVID-19 vaccine safety update : COVID-19 VACCINE JANSSEN
  • Europe – Euro Roundup: UK says local plasma is acceptably safe in immunoglobulin medicines
  • Europe – New treatment for rare autoimmune disease of nerve cells
  • Europe – EMA finalizes guidance on parallel MAA, EU-M4all procedure
  • Europe – Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
  • Europe – New OCABR guidelines on COVID-19 recombinant spike protein vaccines and non-replicating adenovirus-vectored COVID-19 vaccines
  • UK – Novartis’ MS therapy Kesimpta wins NICE backing
  • Europe – Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna
  • Europe – Pharmeuropa 33.2 : les titulaires de CEP invités à commenter les projets de monographies
  • Europe – COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
  • China – Company in China developing inhaled COVID-19 vaccine
  • International – Real-world data suggests Sputnik V vaccine is 97.6% effective, says RDIF
  • USA – GDUFA III: Use MDUFA model to create competition in generic drug markets
  • USA – FDA overdue on guidance as DSCSA deadline looms
  • UK – NICE unveils new strategy to improve patient access to innovative treatments
  • Switzerland – CureVac Swiss AG submits application for authorisation of COVID-19 vaccine (CVnCoV) to Swissmedic
  • USA – Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations
  • Europe – CureVac outlines COVID-19 vaccine production plans ahead of regulatory approval
  • USA – FDA: Master protocols have value in COVID-19, and beyond
  • Europe – Euro Roundup
  • Europe – Changing the labelling and package leaflet (Article 61(3) notifications) : Update
  • Europe – COVID-19 vaccine safety update : Janssen-Cilag International NV
  • Europe – COVID-19 vaccine safety update : COMIRNATY BioNTech Manufacturing GmbH
  • Europe – COVID-19 vaccine safety update : VAXZEVRIA AstraZeneca AB
  • UK – NICE recommends Alexion’s PNH treatment Ultomiris
  • Europe – EMA starts review of VIR-7831 for treating patients with COVID-19
  • France – Plan Healthtech: trois axes de travail pour faire émerger des champions français de la tech en santé
  • USA – FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
  • France – COVID-19 – Nantes : XAV-19, le candidat médicament de Xenothera en bonne voie de validation par les autorités de santé
  • Europe – AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
  • Europe – COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
  • International – Moderna’s booster vaccine for South African variant demonstrates promising early results
  • UK – NICE publishes new guidance on chronic pain management
  • UK – UK trial evaluating ‘mix and match’ COVID-19 vaccine regimens expanded
  • Europe – ProteoGenix Receives European Funding to Develop a Therapeutic Antibody for the Treatment of Inflammatory Rheumatic Diseases
  • USA – NIH trial of anti-CD14 antibody to treat COVID-19 respiratory disease begins
  • Asia – Asia-Pacific Roundup
  • USA – FDA, CDC recommend J&J vaccine pause while rare clots investigated
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
  • UK – NICE ‘no’ for Opdivo/Yervoy lung cancer combo
  • Europe – Pharmeuropa 33.2 just released
  • USA – FDA withdraws 5 opioid ANDAs for no REMS or reports
  • Europe – Le guideline OCABR relatif au vaccin contre le COVID-19 (vaccin à ARNm) est désormais disponible dans son intégralité
  • UK – Findings from the latest COVID-19 REACT-1 study published
  • USA – PDUFA VII postmarketing talks focus on REMS, Sentinel
  • USA – NIH begins study of allergic reactions to Moderna, Pfizer-BioNTech COVID-19 vaccines
  • UK – MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots
  • Europe – AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
  • Europe – EU Individual Case Safety Report (ICSR)1 Implementation Guide
  • UK – NICE backs restricted use of Ondexxya
  • France – La stratégie de Janssen France pour mettre le numérique et la donnée au service de ses activités commerciales
  • UK – Medicines: get scientific advice from MHRA
  • Europe – Outcome of the 169th session of the European Pharmacopoeia Commission
  • USA – FDA offers guidance on generic drug development during COVID
  • USA – Biosimilars industry weighs in on BsUFA II interim assessment
  • USA – FDA seeks to improve on EUA processes, inspections following PREPP review
  • France – Le cannabis médical en phase de test
  • USA – Pfizer/BioNTech: COVID-19 vaccine protects against variant
  • USA – FDA Makes Two Revisions to Moderna COVID-19 Vaccine EUA to Help Increase the Number of Vaccine Doses Available
  • Europe – European Commission kicks off review of pharmaceutical legislation
  • France – L’ANSM publie sa décision sur la demande de RTU pour l’ivermectine dans la prise en charge de la maladie COVID-19
  • UK – NICE recommends Sobi’s Kineret for first-line use in Still’s disease
  • UK – Pfizer/BioNTech’s COVID-19 vaccine is 100% effective in adolescents
  • Europe – AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
  • Europe – Adoption of the revised Raman spectroscopy chapter
  • USA – HHS proposes updates to patient labeling, BA/BE study regulation
  • USA – FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma
  • UK – Single Pfizer/BioNTech dose induces strong immune response to COVID-19
  • Europe – EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
  • Europe – EU recommendations for 2021-2022 seasonal flu vaccine composition
  • Europe – Covid-19 Vaccine Comirnaty : Safety Update
  • Europe – Covid-19 vaccine Vaxzevria : Safety update
  • Europe – Covid-19 Vaccine Moderna : Safety Update
  • Europe – European Commission tightens requirements for duplicate MAAs
  • India – Covishield or Covaxin: Mutant strains in some West Bengal patients raise concerns over vaccine efficacy
  • Europe – Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021
  • Europe – EMA issues advice on use of regdanvimab for treating COVID-19
  • Europe – Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
  • USA – FDA increases OTC monograph facility fees in reissued notice
  • USA – FDA recommends 503B bulks list addition; rejects HCQ sulfate
  • China – Chinese company approved for inhaled COVID-19 vaccine trial
  • Australia – Medicine packaging definitions for sponsors
  • Australia – Standard for serialisation and data matrix codes on medicines
  • Europe – EMA : Marketing Authorisation Holders of centrally authorised medicinal products – classification of changes: questions and answers
  • USA – FDA issues 36 new and revised product-specific guidances
  • Europe – COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases
  • Europe – Coronavirus: new procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants
  • Europe – EMA : Inclusion/exclusion criteria for the “Important Medical Events” list
  • Europe – Le Code de conduite RGPD des essais cliniques rédigé par l’EUCROF a été soumis le 17 mars à la CNIL
  • Australia – Melbourne-made COVID-19 vaccine now available
  • Australia – Medicine labels: Guidance on TGO 91 and TGO 92
  • USA – HHS hits pause on Trump era SUNSET rule
  • USA – COVID innovation lessons could be applied elsewhere
  • Switzerland – COVID-19 vaccine from Johnson & Johnson: Swissmedic approves the third vaccine against COVID-19
  • Europe – EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials
  • UK – NICE recommends Kyprolis triple combination treatment for multiple myeloma
  • Europe – Update : ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use – organisation of CTD – Step 5
  • France – La sérialisation inscrite dans les bonnes pratiques de dispensation dans les pharmacies (JO)
  • Japan – Third Japanese company begins COVID-19 vaccine trials
  • France – la HAS recommande d’utiliser le vaccin d’AstraZeneca chez les 55 ans et plus
  • Europe – Guidance on parallel consultation
  • UK – NICE approves Lynparza plus Avastin via Cancer Drugs Fund
  • Europe – EMA medical terms simplifier
  • USA – FDA Approves First Treatment for Disease That Causes Recurrent Inflammation in Sac Surrounding Heart
  • UK – NICE rejects Keytruda for advanced bladder cancer in final guidance
  • UK – NICE backs AstraZeneca’s Calquence for CLL
  • USA – FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization
  • Canada – Electronic media in prescription drug labelling : Draft guidance
  • Europe – General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs
  • USA – FDA to use real-world data to decide on updating vaccines
  • USA – FDA rolls out dashboard to track COVID-19 drugs
  • Europe – Labelling flexibilities for COVID-19 therapeutics
  • Europe – Novavax: COVID-19 vaccine over 96% effective in UK trial
  • Europe – EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update
  • USA – FDA calls in adcomm to review six more oncology accelerated approvals
  • Europe – Cyberattaque de l’EMA: la Russie et la Chine suspectées
  • Ireland – Safety Update: COVID-19 Vaccines — Overview of National Reporting Experience — 4 March 2021
  • Europe – How CEP holders can avoid the rejection of notifications
  • Europe – Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31 July 2020)
  • Europe – EMA : Quick interactive guide to IRIS registration process
  • UK – NICE rejects AZ’s Lynparza for metastatic prostate cancer
  • USA – FDA sets CDISC implementation timeline
  • Europe – PRAC recommendations on signals adopted at the 8-11 February 2021 PRAC meeting
  • Europe – Questions & Answers on implementation: Impact of the Article 5(3) scientific opinion on nitrosamines in human medicinal products
  • Europe – Pilot project ‘Market Launch of Centrally Authorised Products’
  • USA – Trials without clinical sites offer chance for improved access, generalizability
  • UK – Modified COVID-19 vaccines can avoid ‘lengthy’ clinical studies, says MHRA
  • France – Sérialisation: à peine 1% des officines françaises connectées
  • USA – Novavax seeks FDA emergency approval for COVID-19 vaccine by May
  • Australia – New legislation to support medicine substitutions
  • Australia – TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variants
  • Europe – COVID-19 vaccine safety update for Comirnaty: March 2021
  • UK – NICE rejects rare blood cancer treatment Poteligeo in final appraisal
  • UK – ACCESS Consortium guidance on strain changes in authorised COVID-19 vaccines
  • UK – Final findings from February COVID-19 REACT-1 study published
  • UK – NICE backs NHS use of Lilly’s Olumiant in eczema
  • Europe – COVID-19 treatments: Article 5(3) reviews
  • UK – NICE backs selective internal radiation therapy for advanced liver cancer
  • Europe – Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation
  • Australia – TGA collecting COVID-19 vaccine side effect reports
  • Europe – COVID-19 guidance: assessment and marketing authorisation
  • USA – Updated: FDA issues EUA for J&J’s one-shot COVID vaccine
  • UK – MHRA awards first ‘innovation passport’ under new pathway
  • Europe – Quality and safety assessment for the plasma master file (PMF) certification with regard to donor deferral criteria for sexual risk behaviour
  • Europe – COVID-19 vaccines: under evaluation
  • USA – FDA partially rescinds two approvals after orphan exclusivity mix-up
  • USA – FDA briefing document backs J&J’s one-dose COVID-19 vaccine
  • UK – NICE recommends routine funding for Novartis’ Kisqali
  • Europe – Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
  • Europe – International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
  • UK – Guidance for ‘specials’ manufacturers
  • USA – Moderna sends South Africa variant-specific vaccine for clinical study
  • USA – FDA targets remdesivir, thymosin in compounding concerns
  • USA – Control of Nitrosamine Impurities in Human Drugs : Update
  • France – Veille des études cliniques publiées pour certains médicaments de la Covid-19
  • USA – FDA issues import alert on Indian drugmaker
  • USA – FDA: Include more African Americans in myeloma trials
  • USA – FDA’s OCP 2020 report highlights achievements post-reorganization
  • UK – Guidance : Vitamin D for vulnerable groups -Update
  • Europe – “The collection, testing and use of blood and blood components in Europe”, 2016 report, now available for download from the EDQM
  • USA – FDA’s COVID therapeutics, mAbs guidance accounts for variants
  • Australia – The TGA’s risk management approach
  • Europe – European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021
  • USA – COVID-19 Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
  • Europe – EudraVigilance User Manual
  • Europe – On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services
  • Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe ; Chapter 2
  • Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe : Chapter 8
  • Europe – Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe : Chapter 3
  • Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe : Chapter 1
  • Europe – Products Management Services – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe : Introduction
  • Australia – Advertising COVID-19 vaccines to the Australian public
  • USA – FDA issues import alert on Indian drugmaker
  • USA – 2020 Drug Safety: CDER spotlights COVID-19 activities, nitrosamine contamination
  • UK – Guidance : Managing clinical trials during Coronavirus (COVID-19)
  • Europe – European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines
  • Europe – Pilot phase for CHMP early contact with patient / consumer organisations
  • France – COVID-19 : une biotech française développe un vaccin de 2ème génération qui serait efficace à très long terme
  • France- La pharma grande oubliée du plan cybersécurité
  • USA – FDA approves 948 generic drug applications in 2020
  • Europe – Coronavirus: preparing Europe for the increased threat of variants
  • Europe – Precautionary marketing suspension of thalassaemia medicine Zynteglo
  • Europe – EU approves Tukysa combo for advanced HER2-positive breast cancer
  • UK – NICE rejects Lilly’s Verzenios for advanced breast cancer
  • UK – NICE turns down bluebird bio’s gene therapy Zynteglo
  • USA – Synairgen’s inhaled COVID-19 treatment included in US trial
  • France – Médicament : les conditions de remboursement du Smecta vont se durcir
  • Europe – Euro Roundup: NICE seeks feedback on how it develops health technology guidance
  • USA – FDA working on guidance to address coronavirus variants
  • Europe – EMA, MHRA update on COVID vaccine pharmacovigilance
  • Australia – TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics
  • USA – FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma
  • USA – J&J’s COVID vaccine headed for VRBPAC on 26 February
  • Switzerland – Reports of suspected adverse reactions to the COVID-19 vaccines in Switzerland – Update
  • UK – NICE launches public consultation for process review
  • USA – FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data
  • Europe – Ph. Eur. Supplement 10.6: updated dosage form monographs and general chapters
  • Europe – EMA : Good pharmacovigilance practices
  • USA – FDA: New process for communicating record request issues
  • UK – NICE green light for GSK’s Nucala
  • USA – CBER lays out scaled-down guidance agenda for 2021
  • USA – Analysis: Potentially high NDMA levels after ranitidine ingestion
  • Europe – BPF : essai de libération en temps réel et libération paramétrique
  • Europe – CHMP backs approval of 13 new drugs for various diseases
  • USA – FDA eyes adaptive designs for BE studies impacted by COVID-19
  • India – Dr Reddy’s to seek approval for Sputnik V jab by March
  • UK – Novavax COVID-19 vaccine found to be 89.3% effective in UK trial
  • USA – Exclusion not necessary for EUA vaccine, therapeutic recipients
  • UK – NICE recommends Revlimid for newly diagnosed multiple myeloma patients
  • USA – CDER issues list of draft guidances for release this year
  • USA – Regeneron’s antibody cocktail prevents COVID-19 in high-risk patients
  • USA – A look at FDA’s data on priority and competitive generics
  • Australia – COVID-19 vaccine: Pfizer Australia – COMIRNATY BNT162b2 (mRNA)
  • Europe – Cyberattack on EMA – update 6
  • USA – Moderna says its COVID-19 vaccine works effectively against variants
  • Europe – EMA’s interaction with industry stakeholders – Annual report 2018-2019
  • Europe – NICE no for BMS’ multiple sclerosis drug Zeposia
  • USA – Biden’s day one regulatory freeze
  • Europe – Amid pandemic, EMA’s 2020 authorizations ticked upward
  • USA – FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
  • Europe – COVID-19 and vaccines: Equitable access to vaccination must be ensured
  • Europe – EC asks EMA to accelerate approval of vaccine facilities
  • Europe – Le nouveau Guide technique de la Pharmacopée Européenne pour l’élaboration des monographies de médicaments contenant des substances actives chimiquement définies est désormais disponible
  • UK – NICE publishes final guidance backing Jyseleca for rheumatoid arthritis
  • Europe – Reorganisation of the Romanian blood system – NEW Deadline for tendering: Consultants for the provision of local co-ordination services
  • Australia – COVID-19 vaccine: International collaboration
  • Australia – Novavax COVID vaccine takes first step toward Australian approval
  • USA – Woodcock takes charge as acting FDA commissioner
  • USA – FDA issues guidance on cell, gene therapy manufacturing
  • Ireland – Time-limited conditional exemptions to facilitate supply of medicines to the Irish market
  • China – Report: Chinese COVID-19 vaccine safe for children
  • Europe – EMA : Reporting suspected side effects of medicines in patients with COVID-19
  • International – Trial combining British and Russian COVID-19 vaccines could begin in February
  • UK – Amryt’s Myalepta scores NICE backing for rare lipid disorder
  • USA – FDA: 53 novel drugs approved last year
  • USA – FDA releases assay guidance for COVID-19 antibody drugs
  • France – ANSM : Vaccin anti-Covid – Update
  • Europe – Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
  • UK – Tecartus wins NICE recommendation for mantle cell lymphoma
  • Europe – Transparency: exceptional measures for COVID-19 medicines
  • USA – PREPP initiative: FDA’s COVID-19 response and the path forward
  • Europe – Entrée en vigueur du supplément 10.5 de la Pharmacopée Européenne – Information aux titulaires de CEP
  • USA – FDA issues guidance on resuming or initiating BE studies amid pandemic
  • UK – NICE backs GSK’s Zejula in advanced ovarian cancer
  • UK – Medicines and Medical Devices Bill: overarching documents
  • USA – COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
  • Europe – EMA offers parallel Article 58, centralized authorization reviews
  • Europe – Certification ISO 9001:2015 de l’EDQM maintenue
  • Europe – Treatments and vaccines for COVID-19: medicines under evaluation
  • Switzerland – Swissmedic grants authorisation for the COVID-19 vaccine from Moderna
  • USA – HHS pushes through last-minute policies impacting FDA
  • France – ANSM : L’agence du médicament dévoile ses nouvelles recommandations pour le Lutéran et le Lutényl
  • International – Moderna to develop 3 new mRNA vaccines, one for HIV
  • France – Replay de la conférence WHITE-TILLET « VACCINS anti-COVID : de quoi parle-t-on ? »
  • USA – FDA lays out 2021 regulatory science areas of focus
  • Europe – European Pharmacopoeia Commission adopts new general chapter Contaminant pyrrolizidine alkaloids (2.8.26)
  • USA – FDA offers first thoughts on neurodegenerative disease gene therapies
  • USA – What happened with FDA’s OTC monograph user fee notice?
  • Europe – COVID-19 Vaccine Moderna – Risk-management-plan
  • UK – NICE no for BMS’ Opdivo for head and neck cancer
  • Europe – PRAC recommendations on signals : 23-26 November 2020
  • Europe – Brexit: End of mutual recognition of Official Control Authority Batch Release between the EU/EEA and the UK
  • UK – MHRA : New guidance and information for industry from the MHRA
  • USA – Severe reactions to COVID-19 vaccines very rare
  • France – Distributeurs de produits de santé remboursés
  • China – Conditional OK for Sinopharm’s COVID-19 vaccine
  • USA – ‘N of 1’ therapies addressed in draft FDA guidance
  • Europe – What’s in the Brexit trade deal for the pharmaceutical and medical device industries?
  • UK – Regulatory approval of COVID-19 Vaccine AstraZeneca
  • UK – NICE collaboration creates new route for medicines approval
  • Europe – La Commission européenne de Pharmacopée adopte le nouveau chapitre général Alcaloïdes pyrrolizidiniques contaminants (2.8.26)
  • Europe – European Pharmacopoeia Supplement 10.5 now available
  • USA – Slaoui: Vaccines should control new coronavirus variant
  • India – AstraZeneca vaccine may be approved in India next week
  • Europe – Vaccin PFIZER anti-COVID : le rapport d’évaluation de l’EMA
  • Europe – Euro Roundup
  • USA – FDA guidance targets REMS document e-submission
  • Canada – Health Canada greenlights Moderna’s COVID vaccine
  • UK – SARS-CoV-2 Variant – United Kingdom of Great Britain and Northern Ireland
  • Europe – EMA will review Moderna vaccine Jan. 6
  • USA – Groups seek clarity on interchangeability in BsUFA III
  • France – Victime d’une cyberattaque, le façonnier Fareva réduit fortement ses activités
  • USA – Investigational COVID-19 therapeutics to be evaluated in large clinical trials
  • USA – FDA Issues Emergency Use Authorization for Moderna COVID-19 Vaccine
  • UK – Guidance on submitting clinical trial safety reports from 1 January 2021
  • USA – VRBPAC: Another thumbs up, this time for Moderna’s COVID vaccine
  • USA – FDA approves margetuximab for metastatic HER2-positive breast cancer
  • USA – FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations
  • USA – FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer
  • USA – FDA releases draft guidance on dry eye therapies
  • Europe – COVID-19 guidance: research and development
  • Europe – COVID-19 guidance: assessment and marketing authorisation
  • Europe – Euro Roundup
  • UK – Guidance on MAH and QPPV location from 1 January 2021
  • USA – FDA issues final guidance on controlled correspondence
  • France – Covid-19: l’ANSM choisit l’IA de Synapse Medicine pour la pharmacovigilance des vaccins
  • USA – FDA finalizes guidance on complex innovative trials designs
  • Europe – European Paediatric Formulary: Phosphate Oral Solution open for public consultation in issue 3 of Pharmeuropa PaedForm
  • Europe – EMA : Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
  • Europe – Nitrosamines : Update from the CEP procedure
  • Europe – Levothyroxine tablets product-specific bioequivalence guidance
  • Europe – Overview of comments received on ‘Levothyroxine tablets
  • UK – NICE recommends Novartis’ wet AMD drug Beovu
  • India – India seeks more data on AstraZeneca COVID vaccine
  • Europe – EDQM webinar provides insights on how to implement pharmaceutical care in Europe
  • Australia – Over-the-counter access to low dose cannabidiol
  • USA – CDC’s vaccines panel recommends COVID vaccine; first doses administered
  • UK – MHRA post-transition period information
  • Europe – Le réseau OCABR pour les vaccins à usage humain accueille la TGA parmi ses observateurs
  • Europe – Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
  • Europe – Seven new reference standards available for the analysis of N-nitrosamine impurities
  • UK – NICE u-turn on Novartis’ migraine drug Aimovig
  • UK – New variant of coronavirus identified in the UK
  • UK – Green light for UK trial of nasal coronavirus vaccine
  • Europe – BREXIT : fin de la période de transition au 31 décembre 2020
  • Europe – Cyberattack on EMA – update 1
  • France – Interruption volontaire de grossesse par méthode médicamenteuse – Mise à jour – Note de cadrage
  • USA – FDA issues first Emergency Use Authorization for First COVID-19 Vaccine
  • Europe – EMA and EC action plan on paediatrics
  • UK – Alunbrig scores NICE backing for ALK-positive lung cancer
  • Europe – ICH reflection paper on proposed ICH guideline work to advance patient focused drug Development
  • Europe – COVID-19 : les résultats du vaccin PFIZER publiés dans le NEJM
  • France – Vaccin Covid de Pfizer: «Je n’ai jamais vu autant d’effets secondaires», s’inquiète Eric Caumes
  • Europe – New policy for dissolution and disintegration testing in Ph. Eur. monographs
  • USA – FDA’s proprietary name guidance seeks to avoid medication errors
  • Canada – Health Canada authorizes Pfizer’s mRNA vaccine under interim order
  • Europe – Clinical Trials Information System (CTIS) highlights – December 2020
  • Europe – EMA hit by cyberattack, Pfizer-BioNTech documents accessed
  • USA – VRBPAC to hear of high – and early – efficacy for Pfizer’s COVID vaccine
  • Europe – Bilan de la 168e session de la Commission européenne de Pharmacopée
  • International – Asia-Pacific Roundup
  • Europe – EMA : Buying medicines online
  • USA – Pfizer-BioNTech COVID-19 Vaccine : official FDA assessment result
  • UK – Regulatory approval of Pfizer / BioNTech vaccine for COVID-19
  • UK – Le vaccin Pfizer mis sur le marché sans AMM au Royaume Uni
  • USA – 2021 might be breakthrough year for biosimilars
  • Europe – Update : EMA, WHO and the UMC updated the conditions for data transfer in 2020
  • UK – NICE backs AZ’ Calquence for chronic lymphocytic leukaemia
  • Europe – Joint Strategy sets direction for EMA and EU Medicines Regulatory Agencies to 2025
  • USA – From FDA: How to conduct DDI studies with acid-reducing drugs
  • China – The world may turn to China for COVID-19 vaccine
  • India – India tests 2-dose COVID-19 vaccine despite reduced efficacy
  • Europe – Ph. Eur. Commission adopts a new general chapter for the analysis of N-nitrosamine impurities
  • USA – FDA details feedback request process for combo products
  • USA – Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children
  • Europe – 12 new reference standards and 9 replacement batches released in November 2020
  • USA – ACIP: First, vaccinate health care workers, nursing home residents
  • Australia – COVID-19 vaccines undergoing evaluation
  • USA – FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
  • Europe – Market survey: Data Access to an electronic health care record database from the United Kingdom
  • UK – Guidance on pharmacovigilance procedures from 1 January 2021
  • USA – Moderna files COVID vaccine EUA; adcomm set for 17 December
  • USA – FDA pilots program to encourage new drug development tools
  • Europe – Questions and answers on labelling flexibilities for COVID19 vaccines
  • UK – NICE turns down Novartis’ Adakveo
  • UK – NICE backs use of new treatment for multiple myeloma
  • UK – NICE backs Braftovi for BRAF-positive colorectal cancer
  • Europe – EDQM releases updated European Pharmacopoeia vaccines package for COVID-19 vaccine developers
  • USA – FDA releases draft guidance for drug interaction studies with combined oral contraceptives
  • USA – Draft FDA guidance addresses oncology drug cross labeling
  • UK – Pierre Fabre’s Braftovi scores NICE backing for BRAF+ colorectal cancer
  • Europe – EMA sets 50% efficacy goal – with flexibility – for COVID vaccines
  • Europe – Sanofi gains EU nod to market recombinant flu vaccine
  • UK – NICE recommends Lilly’s migraine med Emgality
  • USA – FDA issues 34 new and revised product-specific guidances
  • Europe – EMA revises remote pharmacovigilance inspections guide
  • India -India testing five COVID-19 vaccines
  • USA – FDA commits to data transparency in COVID EUAs
  • USA – FDA to expedite review of Pfizer, Moderna vaccines
  • USA – Pfizer begins COVID-19 vaccine pilot delivery program
  • USA – FDA finalizes certificates of confidentiality guidance
  • Europe – EMA : Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae
  • UK – Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19
  • Europe – IRIS guide for Parallel Distribution applicants
  • Europe – Consideration on core requirements for RMPs of COVID19 vaccines
  • Europe – Guidance for medicine developers and other stakeholders on COVID-19
  • Europe – Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines
  • UK – NICE green light for Cablivi in rare blood-clotting disorder
  • Europe – Euro Regulatory Roundup
  • Europe – COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs
  • Europe – Rasi signs off as EMA chief, Cooke to take the reins amid pandemic
  • USA – Industry-FDA GDUFA III negotiations seek higher first-round approval rates
  • USA – PDUFA VII: FDA, Industry take up manufacturing, postmarket issues
  • UK – AbbVie’s Venclyxto gets NICE blood cancer backing
  • USA – EUA for COVID antibody calls for additional plant oversight
  • USA – FDA offers strategies to streamline schizophrenia drug trials
  • USA – Novel vaccines typically take 8 years of clinical development: Study
  • USA – FDA finalizes insanitary conditions guidance for compounders
  • Europe – UK and EU agree on phased process for Northern Ireland medicines regulation
  • USA – Makena indication may fall based on post-approval data
  • UK – NICE launches consultation on its methods of drug evaluation
  • UK – NICE backs AbbVie’s Rinvoq for severe active rheumatoid arthritis
  • USA – FDA seeks comment on plan to increase REMS transparency
  • Europe – Euro Regulatory Roundup
  • Europe – CEP holders invited to comment on draft monographs published in Pharmeuropa 32.4
  • USA – COVID antigen tests carry false positive risk: FDA
  • Europe – EU drug watchdog won’t set minimum efficacy levels for potential COVID-19 vaccines
  • Europe – Promising mRNA tech comes with regulatory, CMC headaches
  • France – Le PLFSS pour 2021 ne purge pas la « clause de sauvegarde médicaments » de ses vices, bien au contraire
  • USA – FDA releases list of essential drugs, countermeasures
  • Europe – L’EDQM publie un nouveau document sur les vaccins à vecteur viral recombinant afin d’aider les développeurs de vaccins contre le COVID-19
  • UK – Novo Nordisk’s Saxenda bags NICE recommendation
  • UK – MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions
  • UK – Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs) – letter to industry
  • USA – First vaccine doses may be deployed by year-end
  • USA – FDA revises REMS MAPP for new comparable ETASU provisions
  • Europe – Ensuring the availability of quality standards for medicines in the context of the COVID-19 pandemic
  • Europe – Detailed guidance on ICSRs in the context of COVID-19
  • France – Comment Servier met en œuvre sa transformation numérique
  • France – Suspension des inclusions en France dans les essais clinique évaluant l’anakinra dans la prise en charge de la COVID-19
  • USA – Lack of product-specific guidance slows ANDAs: FDA study
  • Europe – Euro Regulatory Roundup
  • UK – NICE recommends testing womb cancer patients for inherited condition
  • USA – Guidance : Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products
  • Europe – Lessons learnt from presence of N-nitrosamine impurities in sartan medicines
  • UK – UK’s MHRA starts rolling review of Moderna’s COVID-19 vaccine
  • Italy – Italy clears human trials for raloxifene for COVID-19
  • USA – FDA clarifies reference-listed drugs, other ANDA terms in final guidance
  • UK – Bayer’s Nubeqa wins NICE prostate cancer backing
  • USA – FDA postpones DSCA provision enforcement by 3 years
  • Europe – PRAC recommendations on signals
  • USA – FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom
  • UK – ICR urges change as NICE rejects Keytruda plus chemotherapy
  • USA – FDA plans master protocols to monitor COVID vaccine safety, efficacy
  • Europe – Euro Regulatory Roundup
  • USA – FDA Approves First Treatment for COVID-19
  • Europe – Recommendations on eligibility to PRIME scheme
  • UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021
  • USA – FDA issues clarification on insulin pen distribution
  • USA – FDA extends pregnancy warning for common pain relievers
  • France – HAS : Revue rapide sur les tests de détection antigénique du virus SARS-CoV-2
  • USA – FDA launches pilots targeting API, finished dosage QMM
  • Europe – EMA : Guidance for Applicants seeking scientific advice and protocol assistance
  • Europe – Qualification of novel methodologies for drug development: guidance to applicants
  • USA – FDA reissues Chinese respirator EUA, but freezes new additions
  • Europe – EC : Preparedness for COVID-19 vaccination strategies and vaccine deployment
  • UK – Sanofi’s Sarclisa bags NICE recommendation
  • Europe – EMA cancer symposium: New approaches in patient-focused cancer medicine development
  • UK – EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine
  • UK – NICE recommends Novartis’ Mayzent on the heels of SMC approval
  • USA – Testing requirements are likely slowing biosimilar entries in the US
  • Europe – EMA : pre-authorisation procedural advice for users of the centralised procedure
  • USA – Safety concerns stall Lilly’s COVID-19 antibody treatment trial
  • Europe – EMA : Draft Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) Rev. 6
  • Europe – Two new Council of Europe recommendations on quality and safety standards for organ, tissue and cell transplantation in Europe
  • Europe – New Council of Europe guidance on the protection of haematopoietic progenitor cell donors
  • USA – Good real-world outcomes for generic levothyroxine, despite narrow therapeutic index
  • Europe – EMA offers new Q&A on data monitoring committees
  • Europe – Euro Roundup
  • Canada – Guidance : Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications
  • China – Experimental Chinese COVID-19 vaccine is safe, according to researchers
  • UK – Systematic benefit-risk study deems remdesivir a ‘favourable’ COVID-19 treatment
  • USA – FDA issues COVID-19 vaccine EUA guidance after clash with White House
  • USA – CDER’s NextGen Portal now accepts manufacturing capacity submissions
  • Europe – European Medicines Agency mid-year report 2020
  • Europe – EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
  • USA – Consider a variety of endpoints for OUD treatments: FDA guidance
  • Europe – Publication de Pharmeuropa 32.4
  • Europe – Le Supplément 10.4 de la Pharmacopée Européenne est disponible
  • USA – FDA gives draft adjuvant trial guidance for RCC, bladder cancer
  • UK – MHRA issues post-transition orphan, Northern Ireland supply guidance
  • USA – FDA releases draft guidance for physiologically based PK analyses
  • Europe – EU trade groups push Brexit negotiators to act to stop supply disruption
  • UK – NICE backs Sandoz’ Rizmoic
  • Europe – Update : Draft ICH guideline Q3D (R2° on Elemental impurities – Step 2b
  • Europe – New general text on implementation of pharmacopoeial procedures: Ph. Eur. launches public consultation
  • France – Dispositif anti-cadeaux : la dernière pièce du puzzle réglementaire publiée
  • USA – Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances
  • Europe – La Commission européenne de Pharmacopée adopte la version révisée des monographies de formes pharmaceutiques Patchs et Emplâtres médicamenteux
  • USA – Generic drugmakers get guidance on tentative approvals, CRLs
  • USA – CONSORT-AI sets standards for reporting on artificial intelligence in trials
  • USA – FDA updates benzodiazepine boxed warning
  • Europe – EMA addresses use of registry-based studies
  • USA – FDA clarifies evidence for determining intended use
  • USA – Generic drugmakers get cannabidiol bioequivalence guidance from FDA
  • USA – Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance
  • India – COVID-19 vaccine guidelines in India
  • USA – FDA releases guidance on inclusion of geriatric information in drug labeling
  • UK – Brexit Readiness Checklist for companies doing business with the UK
  • International – WHO: Two-thirds of global population now participating in COVAX initiative
  • USA – FDA explains how to measure symptoms in COVID-19 trials
  • UK – BMS’ Opdivo wins new NICE lung cancer backing
  • UK – NICE u-turn sees Akcea’s Waylivra win NHS funding
  • Australia – Testing of medicinal cannabis products being supplied via SAS in Australia
  • Europe – Convergence: EMA close to finalizing guidance for advanced therapies
  • Europe – Update : The suspension of clinical data publication does not apply to COVID-19 related products
  • USA – Guidance : Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
  • China – China begins trial of COVID-19 vaccine spray
  • Australia – Dosing begins for COVID-19 Phase I/II trial in Australia
  • USA – Pfizer to broaden diversity of COVID-19 vaccine trial
  • UK – Inhaled coronavirus vaccines to be tested in UK
  • USA – Guidance : Eosinophilic Esophagitis: Developing Drugs for Treatment
  • USA – FDA releases temporary guidance on production operations
  • UK – NICE backing for AZ’ Tagrisso
  • International – AstraZeneca resumes trial of COVID-19 vaccine
  • UK – NICE backs Portola’s Ondexxya
  • France – Amende record pour NOVARTIS, ROCHE et GENENTECH
  • Europe – EU vows to hold COVID vaccine firms liable for side effects
  • UK – NICE turns down Celgene’s Revlimid as multiple myeloma maintenance treatment
  • USA – Drugmakers, FDA try to build public confidence in COVID vaccine decisions
  • USA – FDA updates PK guidance for patients with impaired renal function
  • Europe – Recombinant factor C: new Ph. Eur. chapter available as of 1 July 2020
  • UK – NICE no for Pierre Fabre’s Braftovi
  • UK – Updated guidance on pharmacovigilance procedures
  • USA – COVID convalescent plasma guidance gets EUA updates
  • UK – MHRA: Post-transition guidance on licensing medicines
  • USA – N-Nitrosamine impurities: FDA issues detection, prevention guidance
  • France – L’Institut du cancer Sainte-Catherine d’Avignon va expérimenter un distributeur de médicaments connecté
  • UK – Janssen disappointed with second NICE no for Spravato
  • Europe – EMA finalizes pediatric trial preparedness framework
  • UK – MHRA posts suite of post-transition guidances
  • UK – NICE green light for immunotherapy Bavencio
  • USA – Guidance : Control of Nitrosamine Impurities in Human Drugs
  • USA – Combination products: FDA releases PDUVA VI program report
  • USA – PDUFA VI: Assessment of Combination Product Review Practices in PDUFA VI
  • USA – FDA issues 36 new and revised product-specific guidances
  • USA – FDA explains transfer of ownership policy for generics
  • USA – COVID-19 vax AdComm booked for the 22nd
  • UK – Kidney cancer charity slams NICE rejection of Keytruda/Inlyta
  • USA – FDA addresses nitrosamines in TB drugs
  • USA – FDA drafts recommendations for studying cancer drugs in patients with CNS metastases
  • USA – ANDA consolidation process updated in new MAPP
  • USA – FDA clears trial for cannabinoid drug for COVID-19
  • USA – FDA Issues EUA for Convalescent Plasma as Potential Promising COVID–19 Treatment
  • China – China: First COVID-19 vaccine patent granted to CanSino
  • USA – Acute pain treatment guideline released
  • France – Réglementation anti-cadeaux – les montants enfin publiés
  • UK – CMOs urge trusts to continue recruiting for RECOVERY trial
  • Canada – Health Canada adopts ICH pediatric drug development guidance
  • UK – NICE recommends Roche’s Polivy for B-cell lymphoma
  • China – China’s CDE creates COVID-19 vaccine development guidelines
  • USA – Guidance : Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
  • Canada – Canada extends non-COVID clinical trial review times
  • USA – Draft AML guidance takes targeted therapies into account
  • UK – NICE publishes guidance on Astellas’ Xospata
  • Europe – Nitrosamines risk assessment: update for CEP holders
  • USA – FDA finalizes penalties for trial reporting violations
  • USA – Guidance : Male Breast Cancer – Developing Drugs for Treatment
  • Europe – Update on the review of the CEP application regarding an impurity in the active substance paracetamol
  • Europe – European Commission reviews impact of orphan, pediatric regulations
  • USA – FDA updates guide for e-submission of trial data
  • Australia – Study affirms safety of human papillomavirus (HPV) vaccine
  • USA – FDA guides drug-drug interaction studies for therapeutic proteins
  • USA – Marketing status notifications: FDA fills in details in final guidance
  • Europe – Validation issues frequently seen with initial MAAs
  • USA – Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices
  • USA – US FDA launches pilot program for RFD and Pre-RFD electronic submissions process
  • Europe – Euro Regulatory Roundup
  • Europe – EMA addresses risk evaluation, mitigation for nitrosamines
  • UK – NICE updates guidance on chronic pain treatments
  • USA – LPAD pathway: FDA finalizes guidance
  • USA – FDA provides guidance on preparation and submission of pediatric study plans
  • Canada – The Canadian application process and alternate pathway for COVID-19‒related clinical trials
  • Europe – European Partnership under Horizon Europe : Draft proposal
  • USA – US secures 100M doses of Sanofi-GSK COVID-19 vaccine
  • USA – FDA Purple Book Database now includes all CBER-, CDER-licensed biological products
  • USA – FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
  • UK – NICE backs Bavencio combo for kidney cancer
  • USA – Glycolic acid, TCA among proposed additions to 503B bulk drugs list
  • USA – FDA issues new unit-dose repackaging guidance
  • UK – NICE rejects NHS funding for Kyowa Kirin’s Poteligeo
  • USA – FDA issues at-home and OTC COVID-19 testing template
  • USA – FDA may authorize convalescent plasma for COVID-19
  • USA – FDA addresses endotoxin levels in investigational cancer treatments
  • USA – FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora
  • Europe – Recommendations on common regulatory approaches for allergen products
  • USA – Moderna’s COVID-19 vaccine enters pivotal phase 3 trial
  • USA – Pfizer, BioNTech identify and advance lead COVID-19 vaccine candidate
  • USA – Gene therapies: Industry asks for clarification on FDA’s sameness guidance
  • India – Coronavirus Vaccine Race: Most of the Covid-19 vaccines are already reserved
  • USA – Phase 3 clinical trial of investigational vaccine for COVID-19 begins
  • India – Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices
  • Europe – EMA: Thumbs up for 11, down for 2 new medicines
  • USA – Excipients group seeks GDUFA III participation
  • USA – US regulations for regenerative medicine advanced therapies
  • Europe – EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
  • USA – PDUFA VII: FDA, industry preview their reauthorization wish lists
  • USA – FDA proposes reporting rule for Right to Try Act
  • USA – Opioid labeling to include naloxone counseling recommendation
  • Canada – Release of ICH E9(R1): Defining the Appropriate Estimand for a Clinical Trial/ Sensitivity Analyses
  • Europe – Guidance document on Aquatic and Sediment Toxicological Testing of Nanomaterials
  • Europe – Guidance Document for the testing of Dissolution and Dispersion stability of Nanomaterials and the use of the Data for further Environmental testing and Assessment strategies
  • Europe – Overview of REACH information requirements and available methods
  • Europe – 22 hazardous chemicals added to EU regulation on imports and exports
  • USA – FDA kicks off GDUFA III reauthorization process
  • USA – FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research
  • UK – Gov signs deals with BioNTech/Pfizer and Valneva for COVID vaccines
  • USA – Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
  • UK – Synairgen’s SNG001 shows strong promise in COVID-19 trial
  • UK – NICE backing for Astella’s Xospata
  • Europe – Advanced therapy medicinal products regulations in the EU
  • Europe – Industry calls for IP protection, innovation support in EC pharmaceutical roadmap
  • Europe – Vaccine against COVID-19: Council adopts measures to facilitate swift development
  • USA – Experts urge transparency, advisory committee review for COVID-19 vaccines
  • Europe – Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the EMA
  • USA – FDA withdraws 20 guidances
  • USA – FDA could restart inspections at domestic sites this month
  • Europe – EU agencies urge sponsors to ensure post-Brexit compliance with clinical trial rules
  • USA – FDA finalizes guidance on broader cancer trial eligibility
  • Australia – Australia’s first COVID treatment approved
  • International – ICMRA outlines shape of Phase 3 COVID-19 vaccine trials
  • UK – NICE backing for Takeda’s Adcetris for rare lymphoma
  • USA – Unified agenda: FDA publishes lengthy to-do list
  • Europe – Launch of public consultation on joint network strategy to 2025
  • UK – Britain closes in on £500m COVID-19 vaccine deal with Sanofi/GSK
  • USA – FDA moving away from PDFs to digital submissions
  • Europe – Guidance for medicine developers and companies on COVID-19
  • Europe – Clinical Trials Information System (CTIS) highlights – June 2020
  • Europe – ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – questions & answers
  • USA – A compilation of FDA COVID-19-related guidelines
  • Europe – International regulators provide guiding principles for COVID-19 clinical trials
  • Europe – EU agencies clarify pharmacovigilance expectations amid COVID-19
  • USA – COVID-19 guidelines updated to include steroids
  • USA – Guidance : Development and Licensure of Vaccines to Prevent COVID-19
  • USA – FDA : Guidance Documents – Recently Issued
  • USA – Guidance : Pediatric anti-infective development addressed by FDA
  • Europe – Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
  • USA – Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance
  • Europe – Eight medicines leap towards EU approval
  • France – FDA launches online forum for drug repurposing
  • Europe – Le cahier Orphanet « List of expert reviewers 2019 » est en ligne
  • USA – FDA seeks input on genotyping for pediatric codeine use
  • UK – NICE sticks to Zytiga rejection
  • UK – NICE rejects Novartis’ Mayzent for secondary progressive MS
  • UK – NICE green light for Roche’s Rozlytrek
  • USA – FDA gives Project Renewal update at AACR
  • USA – FDA finalizes bacterial pneumonia drug development guidances
  • France – Sanofi accelerates coronavirus vaccine plans
  • USA – FDA program to share patient-reported outcomes in cancer drug trials
  • Brazil – Brazil to launch human trials of Oxford’s COVID-19 vaccine
  • Europe – From laboratory to patient: the journey of a centrally authorised medicine
  • USA – FDA: Follow CDC guidance for COVID-infected employees
  • Europe – Consultation on the pilot project ‘Market Launch Intentions of Centrally Authorised Products’
  • Australia – Transition to new GMP requirements for medicinal products
  • France – Thérapie génique : des vecteurs plus performants grâce à la chimie
  • France – Le gouvernement veut relocaliser toute la chaîne de production du paracétamol en France
  • USA – FDA officials update on orphan drugs, gene therapies at DIA
  • Europe – European Commission proposes relaxing GMO regs for COVID-19 vaccines
  • Europe – Procedural advice for orphan medicinal product designation
  • UK – Government authorises use of dexamethasone for COVID-19
  • China – Sinovac reveals positive preliminary data for COVID-19 vaccine
  • UK – Final NICE green light for Janssen’s Stelara in UC
  • UK – MHRA suspends COVID-19 hydroxychloroquine trials
  • UK – Dexamethasone cut deaths by 35% in ventilated COVID-19 patients
  • USA – FDA guidance offers statistical advice for clinical trials
  • USA -First patient-focused drug development guidance released
  • USA – FDA updates platform for off-label drug use
  • USA – Cytokine storm treatments being tested for COVID-19
  • USA – FDA releases MAPP for converting ANDA status for patent infringement
  • USA – FDA warns of potential drug interaction with remdesivir
  • USA – FDA revokes EUA for hydroxychloroquine, chloroquine
  • UK – NICE backs Rozlytrek for subset of NSCLC patients
  • Europe – EMA : Annual report 2019 published
  • Europe – Oxford inks manufacturing deal for COVID-19 vaccine
  • UK – NICE rejects Sanofi’s Cablivi in draft guidelines
  • USA – Experts address clinical challenges for ultra-rare diseases at BIO
  • Europe – MHRA puts speed-to-market at center of post-Brexit vision
  • Europe – IRIS guide to registration
  • Europe – EMA affirms ACE inhibitors, ARBs safe during COVID-19
  • Europe – NITROSAMINES : actualité réglementaire
  • Europe – Impact of COVID-19 crisis – National authorities in Europe report shortages of medical products and increase in illegal activities
  • Europe – European Medicines Agency’s Privacy Statement : For the Industry Single Point of Contact (i-SPOC) system
  • Europe – Fast-track procedures for treatments and vaccines for COVID-19
  • UK – NICE rejects Sanofi’s Sarclisa in preliminary guidelines
  • USA – FDA releases compliance program for CDER, CDRH-led combination product inspections
  • USA – Fauci: US will have 100M doses of COVID-19 vaccine by year-end
  • USA – GAO voices concern about FDA’s foreign drug inspection practices
  • Europe – PIC/S adopts cross-contamination, HBEL guides
  • Europe – EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe
  • Europe – Patients’ and healthcare professionals’ organisations updated on EMA’s response to COVID-19
  • Europe – Four European nations form alliance to fast-track COVID-19 vaccine
  • UK – NICE publishes final guidance backing Teva’s Ajovy for migraine
  • USA – FDA issues 69 new and revised draft product-specific guidances
  • Europe – European Commission consults on roadmap to pharmaceutical reforms
  • India – 14 vaccine candidates from India look promising
  • Europe – EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
  • Germany – Drug shortages in Germany ‒ A critical appraisal
  • India – India lifts export restrictions on paracetamol API
  • USA – FDA seeks input on rare disease clinical trials network
  • USA – FDA looks to overhaul Orange Book, seeks input on patent listings
  • Europe – COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
  • Canada – Health Canada releases guidance to streamline COVID-19 clinical trials
  • Europe – European medicines regulatory network fully mobilised in fight against COVID-19
  • Europe – European Medicines Regulatory Network COVID-19 Business Continuity Plan
  • Europe – Qualification of digital technology-based methodologies to support approval of medicinal products (Questions and Answers)
  • UK – NICE issues final guidance on NHS use of Bayer’s Vitrakvi
  • UK – NHS patients to be given experimental coronavirus therapy remdesivir
  • UK – MHRA supports the use of remdesivir as the first medicine to treat COVID-19 in the UK
  • USA – FDA consults on ICH residual solvents update
  • Europe – ENCePP Steering group: Mandate for ENCePP support to COVID-19 activities
  • China – New Drug Approvals in China in 2019
  • UK – NICE u-turn backs Roche’s Tecentriq for triple negative breast cancer
  • USA – FDA updates COVID-19 compounding guidance with reporting clarification
  • Europe – EU Regulatory Roundup: Neuropsychiatric disorders prompt safety probe of hydroxychloroquine
  • UK – Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices
  • USA – Epinephrine and morphine added to FDA’s COVID-19 compounding lists
  • Europe – EMA EudraVigilance Registration Manual
  • Europe – Checklist for Initial Notifications for Parallel Distribution
  • USA – FDA guidance targets adverse event reporting during trials
  • UK – NHS can procure drugs for use outside of their approved indications if it’s cheaper, court says
  • Australia – Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines
  • Europe – European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
  • Europe – Rasi: EMA may conditionally authorize remdesivir in the ‘coming days’
  • Europe – European Pharmacopoeia welcomes Mexico as observer state
  • UK – New COVID-10 guidelines for CKD and interstitial lung disease
  • USA – FDA updates clinical trial guidance for drugs, devices
  • Europe – EMA waives certain GMP inspection fees during COVID-19
  • Europe – EU actions to support availability of medicines during COVID-19 pandemic – update #6
  • India – India to test four drugs as part of WHO trial
  • USA – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
  • UK – NICE backs Roche’s Gazyvaro, Pfizer’s Lorviqua in new guidance
  • USA – Blood cancer candidates gain orphan tag from FDA
  • USA – FDA issues two guidances to accelerate COVID-19 treatments
  • USA – Purple Book: FDA adds transition biologics as move to single database progresses
  • UK – Researchers assessing use of tick molecule for COVID-19
  • Europe – Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures
  • Europe – Plasma master file certificates
  • USA – COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
  • Europe – PRAC recommendations on signals : adopted at the 14-17 April 2020 PRAC meeting
  • UK – NICE backs Roche’s Kadcyla for HER2-positive early breast cancer
  • Europe – European Pharmacopoeia: Adoption of a new general chapter on Multivariate Statistical Process Control
  • Europe – Recommendations on eligibility to PRIME scheme
  • Europe – EU actions to support availability of medicines during COVID-19 pandemic – update #5
  • USA – FDA finalizes guidance on drugs for cytomegalovirus in transplant patients
  • USA – Outsourcing in regulatory operations
  • France – Point d’étape sur l’essai Discovery promu par l’Inserm
  • Europe – EMA : News bulletin for small and medium-sized enterprises
  • UK – NICE publishes rapid COVID-19 guideline for acute kidney injury
  • UK – ICR welcomes new advanced prostate cancer treatment guideline
  • France – Le Leem lance un nouveau « 100 Questions sur le médicament »
  • Europe – Outcome of the 166th session European Pharmacopoeia Commission
  • USA – CDER releases policy for handling newly identified safety signals
  • Europe – Oxygen 98%: Ph. Eur. requests feedback on new oxygen quality to boost availability
  • Europe – Guideline on Good Pharmacovigilance practices (GVP) : Module Vll – UPDATE
  • UK – NICE publishes latest set of COVID-19 guidelines
  • USA – Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance
  • USA – Guidance : Charging for Investigational Drugs Under an IND – Questions and Answers
  • USA – Guidance : Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes
  • USA – Guidance : Specification of the Unique Facility Identifier (UFI) System for Drug Establishment
  • USA – Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance
  • USA – Special Protocol Assessment Guidance
  • USA – FDA authorizes Gilead’s remdesivir for emergency use
  • UK – NICE joins international COVID-19 pandemic response
  • USA – Guidance : Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency
  • Europe – EU actions to support availability of medicines during COVID-19 pandemic – update #4
  • France – Immunoglobulines humaines normales (IgHN) et COVID-19 : utilisations abusives ?
  • USA – FDA works with drugmakers on shortages
  • USA – FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19
  • USA – Statistical Approaches to Establishing Bioequivalence
  • Europe – EMA warns against using unproven cell-based therapies
  • Australia – TGA begins virtual GMP inspections of domestic manufacturers
  • UK – NICE u-turn backs Stelara for UC
  • Europe – Reporting suspected side effects of medicines in patients with COVID-19
  • UK – NICE publishes new COVID-19 guidelines
  • UK – NICE rejects NHS funding for Portola’s Ondexxya
  • International – WHO prematurely publishes remdesivir results
  • USA – Residual Solvents in Drug Products Marketed in the United States
  • USA – Residual Drug in Transdermal and Related Drug Delivery Systems
  • USA – Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
  • USA – Guidance : Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax
  • USA – ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
  • USA – ANDAs: Impurities in Drug Substances
  • UK – NICE backs NHS use of Bayer’s Vitrakvi via the CDF
  • Europe – EudraVigilance user manual for marketing authorisation holders
  • USA – Expert U.S. panel develops NIH treatment guidelines for COVID-19
  • Europe – Launch of enhanced monitoring system for availability of medicines used for treating COVID-19
  • Europe – COVID-19: What’s new
  • Europe – Detailed guidance on ICSRs in the context of COVID-19
  • Europe – Procedural guidance during COVID-19 pandemic
  • USA – Guidance : S9 Nonclinical Evaluation for Anticancer Pharmaceuticals–Questions and Answers
  • Europe – EMA’s governance during COVID-19 pandemic
  • Europe – Public-health advice during COVID-19 pandemic
  • Europe – Guidance for medicine developers and companies on COVID-19
  • Europe – Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA)
  • Canada – Health Canada responds to COVID-19 emergency
  • USA – Qualification of Biomarker — Galactomannan in studies of treatments of invasive
  • Europe – ‘Treatment effect measures when using recurrent event endpoints qualification opinion’ – overview of comments
  • USA – Q8(R2) Pharmaceutical Development
  • USA – Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
  • USA – Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
  • USA – Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
  • USA – Q2B Validation of Analytical Procedures: Methodology
  • USA – Q2A Text on Validation of Analytical Procedures
  • USA – Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)
  • Europe – CMDh Rules of Procedure
  • USA – Q9 Quality Risk Management
  • USA – Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
  • USA – Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
  • USA – Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
  • Europe – Prioritisation of activities related to CEPs during COVID-19 contingency measures period
  • USA – Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate
  • USA – Q4B Annex 14 : Bacterial Endotoxins Test
  • USA – Q4B Annex 12 : Analytical Sieving
  • USA – Q4B Annex 11 : Evaluation and Recommendation of Pharmacopoeial Texts
  • USA – Q4B Annex 9: Tablet Friability
  • USA – Q4B Annex 8: Sterility Test
  • USA – Q4B Annex 6: Uniformity of Dosage Units
  • USA – Q4B Annex 5: Disintegration Test
  • USA – Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
  • USA – Q4B Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms
  • USA – Q4B Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration
  • USA – Q4B Annex 1: Residue on Ignition/Sulphated Ash
  • France – ANSM : Médicaments utilisés chez les patients atteints du COVID-19 : une surveillance renforcée des effets indésirables
  • Australia – Study tests ivermectin in lab-grown COVID-19 cells
  • India – India withdraws export ban on antimalarial drug
  • USA – Guidance : Investigational COVID-19 Convalescent Plasma
  • Europe – Guidance on the collection and transfusion of convalescent COVID-19 plasma
  • Europe – EC Offers Antitrust Reassurances to Generic Drugmakers Cooperating on Shortages
  • USA – API supply from China is stable, FDA says
  • USA – Compounding Drugs During the Pandemic: FDA Offers Policy Clarifications
  • Europe – Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-Nitrosamines
  • USA – OTC Monograph Reform is Now Law: What’s Next?
  • USA – Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency
  • UK – NICE publishes four more rapid guidelines in response to pandemic
  • USA – Moderna chairman says COVID-19 vaccine could begin phase 2 trials in spring
  • USA – Why FDA’s Issuance of EUAs are Not ‘Approvals’ and Why That Matters
  • France – Hydroxychloroquine : un essai clinique français bien conçu est conduit dans 37 hôpitaux
  • Europe – EU Regulatory Roundup
  • Europe – Products and extemporaneous preparation of paediatric formulations that may be useful in the treatment of COVID-19
  • UK – MHRA regulatory flexibilities resulting from coronavirus (COVID-19)
  • UK – NICE publishes second set of rapid COVID-19 guidelines
  • USA – FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
  • Europe – Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2020/2021
  • Europe – ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals : Step 5
  • Europe – MHRA Blocks 135 Drugs From Parallel Export
  • Europe – Advancing regulatory science in the EU – new strategy adopted
  • Europe – Information on Nitrosamines for Marketing Authorisation Holders
  • Europe – Point sur la politique de la Ph. Eur. relative aux impuretés élémentaires – Excipients d’origine naturelle
  • India – A coronavirus vaccine in 18 months? Experts urge reality check
  • USA – COVID-19 Therapeutics Tracker
  • UK – COVID-19: NICE updates guideline as Sanofi announces vaccine development
  • India – Intas to provide 2 million hydroxychloroquine tablets for WHO study on COVID-19
  • Europe – EMA : Information package for certificates of medicinal products
  • France – L’ANSM alerte sur les «effets secondaires» des traitements contre le coronavirus
  • USA – Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act
  • USA – Gilead’s withdrawal of orphan status of COVID-19 candidate
  • USA – FDA, Grifols to develop plasma therapeutics for COVID-19
  • Europe – Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31st July 2020).
  • Europe – Products and extemporaneous preparation of paediatric formulations that may be useful in the treatment of Covid-19
  • Europe – Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
  • Europe – EudraVigilance Operational Plan
  • USA – Convalescent Plasma: FDA Facilitating Emergency Access
  • France – French authorities suspend processing of permit requests
  • Europe – Les vaccins tétaniques dans la Pharmacopée Européenne – rationalisation des exigences relatives à la toxicité
  • International – FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development
  • Europe – Guidance on paediatric submissions
  • USA – FDA: No clear proof NSAIDS can worsen COVID-19
  • USA – Policy for Certain REMS Requirements During the COVID19 Public Health Emergency : Guidance
  • USA – FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment
  • USA – Antimalarial drugs, remdesivir tested for COVID-19
  • Europe – EMA Offers Guidance on Conducting Trials During the COVID-19 Pandemic
  • France – Pharmacovigilance: un site internet pour vérifier si un médicament présente des risques en cas de symptômes de Covid-19
  • USA – FDA Looks to Speed Access to Potential COVID-19 Treatments
  • USA – FDA Revamps Adverse Event Reporting Guidance for COVID-19
  • USA – FDA suspends routine domestic inspections
  • Europe – EMA Management Board – highlights of March 2020 meeting
  • Europe – Clinical Trial Regulation : Update
  • Europe – Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
  • Europe – EudraVigilance – Inclusion/exclusion criteria for the ‘Important medical events’ list
  • USA – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
  • Europe – New Council of Europe resolution to promote pharmaceutical care in Europe
  • USA – FDA Drafts Guidance on Restricted Delivery Systems for Liquid Drugs
  • USA – Drug industry groups oppose FDA’s drug importation plan
  • USA – Safety testing for coronavirus vaccine begins
  • USA – Competitive Generic Therapies Guidance for Industry
  • UK – Advice for Management of Clinical trials in relation to Coronavirus
  • Europe – Impact de la propagation du Covid-19 sur la procédure CEP
  • UK – Ajovy bags NICE approval
  • UK – NICE hits Keytruda with ‘no’ for urothelial cancer
  • USA – Drug shortages: Current list now available
  • USA – FDA guidance details submissions in alternate electronic formats
  • USA – Coronavirus delays many FDA foreign inspections
  • France – Remises négociées sur le prix des médicaments et définition du chiffre d’affaires des laboratoires
  • France – Principles of medicinal products assessment and appraisal for reimbursement purposes
  • USA – New guidance on biologics affects authorized generics
  • USA – FDA Revamps Safety Testing for new Type 2 Diabetes Drugs
  • USA – FDA Encourages Inclusion of Older Patients in Cancer Trials
  • UK – UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiation Plan
  • USA – Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance
  • Europe – Market Access: making the process easier and efficient
  • Europe – Revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4 – Second targeted stakeholders’ consultation
  • India – CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs
  • USA – FDA urged to ID drug in shortage due to coronavirus
  • Europe – European Pharmacopoeia revises general chapter on degree of coloration of liquids
  • Europe – European Pharmacopoeia updates testing for particulate contamination in pharmaceutical preparations
  • UK – NICE pushes Doptelet for pre-surgery liver disease treatment
  • Europe – Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)
  • USA – Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
  • USA – ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications
  • USA – Determining Whether to Submit an ANDA or a 505(b)(2) Application – Guidance for Industry
  • USA – FDA seeks ways to promote individualized therapies
  • Europe – Guideline on Good Pharmacovigilance Practices (GVP) Module VII – Explanatory Note
  • Europe – 4 new reference standards and 19 replacement batches released in February 2020
  • France – La Cour de cassation vient de valider la résolution d’un contrat commercial pour manquement à la loi « anti-cadeaux », à la Transparence et au FCPA
  • Australia – International scientific guidelines adopted in Australia
  • USA – FDA Issues 43 Product-Specific Guidances for Generic Drugs
  • Europe – Updated Brexit-related guidance for companies will be published shortly
  • USA – Guidance Snapshot Pilot
  • USA – Guidance : Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
  • UK – Revlimid gets NICE nod for lymphoma
  • USA – FDA: No drug shortages reported due to coronavirus
  • UK – Polivy struck by NICE ‘no’
  • Europe – Deuxième consultation ciblée de la version 12 de l’Annexe 1 relative à la fabrication des médicaments stériles
  • Europe – Vers une plus grande coopération des pharmacopées mondiales
  • USA – New AI-created antibiotic can kill many antibiotic-resistant bacteria
  • USA – Drug Approvals: FDA Publishes Dataset of CDER Approvals Since 1985
  • USA – FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents
  • USA – FDA launches new resource to provide easily accessible, more accurate historical drug approval data
  • France – Leem : Etude 2019 sur les Médicaments de thérapie innovante (MTI) – Une place de leader européen à prendre pour la France ?
  • USA – FDA report details how agency supports generic-drug development
  • USA – FDA changes biological product definition
  • USA – FDA unveils gene-drug interaction table
  • Europe – La Pharmacopée Européenne met à jour le contrôle de la contamination particulaire dans les préparations pharmaceutiques
  • USA – FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance
  • USA – eCTD Technical Conformance Guide
  • Canada – Implementation of eCTD for clinical trial regulatory activities
  • USA – FDA teams with India to stop counterfeit shipments
  • Europe – ICH S5 (R3) guideline on reproductive toxicology
  • Europe – Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation
  • USA – Modernizing ClinicalTrials.gov: NIH Seeks Feedback
  • Europe – European Commission DG Health and Food Safety and European Medicines Agency Action Plan on ATMPs
  • China – La Chine vend un médicament contre le coronavirus
  • USA – Human Somatic Cell Therapy : Content and Review of Chemistry, Manufacturing, and Control (INDs)
  • USA – Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
  • Europe – ”Blue – Box” requirements
  • UK – UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul
  • Europe – Ph. Eur. Supplement 10.2: CEP holders are invited to update their applications
  • UK – NICE refuses Keytruda, Inlyta cancer combo
  • Europe – CAT monthly report of application procedures, guidelines and related documents on advanced therapies
  • Europe – Recommendations to stakeholders on plasma supply management
  • Asia – Asia Regulatory Roundup
  • Europe – Substances, Products, Organisations, Referentials (SPOR)
  • Europe – Chapter 7 : Implementation of ISO standards for the identification of medicinal products in Europe
  • Europe – Chapter 6 : Implementation of ISO standards for the identification of medicinal products in Europe
  • Europe – Chapter 2 : Implementation of ISO standards for the identification of medicinal products in Europe
  • Europe – Chapter 1 : Implementation of ISO standards for the identification of medicinal products in Europe
  • Europe – Intro : Implementation of ISO standards for the identification of medicinal products in Europe
  • Europe – La Pharmacopée européenne accueille son 39ème État membre : l’Albanie
  • Europe – Member states contact points for translations review
  • France – Vente en ligne de médicaments : l’Ordre préoccupé par les risques que présente le projet de loi « simplification » pour la sécurité des patients
  • Europe – EMA : Brexit and Multiannual programming
  • USA – FDA drafts guidance for biosimilar, reference product labels
  • Europe – Nitrosamines : Que doit-on faire ?
  • Europe – Nitrosamine contamination: new web page on EDQM response
  • Australia – Microbiological quality of medicinal cannabis products
  • Spain – Spain Creates Guide to Sharing Information About Nitrosamine Testing
  • USA – FDA Targets Faster Reviews for Biosimilar Supplements, Draft Guidance Says
  • Europe – 1 nouvel étalon de référence de la Ph. Eur. et 29 lots de remplacement libérés en janvier 2020
  • Europe – Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group
  • Europe – Quality of medicines questions and answers: Part 1
  • USA – Industry Supports FDA’s Plans to Review Novel Excipients Outside of Applications
  • Europe – Brexit happened. EU MDR looms. 3 key questions on medtech’s future in Europe
  • Europe – United Kingdom’s withdrawal from the European Union
  • UK – NICE plans to widen the net for data it uses in guidance
  • UK – Rinvoq NICE approval could benefit 54,000 people
  • Japan – Researchers in Japan transplant lab-grown heart cells into human
  • USA – Biologic and Biosimilar Misinformation: FDA Drafts Guidance
  • USA – Revised MAPP Tightens FDA Scope for Prioritized Generic Drug Applications
  • UK – MHRA, EMA issue guidelines on eve of Brexit
  • Europe – IRIS guide to registration
  • USA – Database for ARV HIV drugs launched by FDA
  • Europe – EU agencies seek to develop common standards for medicine ePI
  • UK – What Happens to SPCs and Patents After the Brexit Transition Period
  • Europe – Brexit: Council adopts decision to conclude the withdrawal agreement
  • USA – 2020 CDER Draft and Revised Guidance: What’s Coming
  • Europe – Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA)
  • Europe – Key principles for the use of electronic product information for EU medicines
  • USA – OPDP Plots Research on Indication, Endpoint Perceptions in Cancer Drug TV Ads
  • Europe – Nitrosamine contamination: new web page on EDQM response
  • India – India’s CDSCO Publishes List of Drugs Covered by Bioequivalence Study Rules
  • USA – FDA Finalizes 6 Gene Therapy Guidances, Unveils a New Draft
  • UK – NICE knocks back J&J’s depression nasal spray Spravato
  • France – La HAS présente son plan d’action pour les médicaments innovants
  • Germany – IQWiG: ‘Quality’ Registry Data Suitable for Benefit Assessments
  • UK – NICE rejections continue, hitting Novo’s Saxenda next
  • USA – Current Good Manufacturing Practice—Guidance for Human Drug 2 Compounding Outsourcing Facilities 3 Under Section 503B of the FD&C Act
  • USA – FDA Seeks Help Using Algorithms to Detect Adverse Event Anomalies
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  • Europe – EMA licenses Mayzent for MS
  • UK – NICE rejects Janssen’s Stelara on cost efficiency grounds
  • USA – OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show
  • Europe – Reflection paper on Good Manufacturing Practice and 7 Marketing Authorisation Holders
  • USA – FDA to Allow Online Submissions of Orphan Designation Requests
  • USA – MAPP Further Explains FDA Process for Reviewing REMS Assessment Reports
  • USA – NASEM Calls on WHO to Expand its Prequalification Program
  • UK – Ibrance given NICE green light in breast cancer
  • UK – Vitrakvi deemed ‘not cost-effective’ by NICE
  • UK – NICE ‘OK’ for Lynparza
  • USA – Study: Speedier reviews might have compromised rigor of FDA approval
  • USA – Pediatric Study Plans for Oncology Drugs : Q & A
  • USA – 3 More NDAs Will Become BLAs
  • UK – NICE rejects Keytruda, asks for more info
  • USA – Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data
  • USA – FDA Warns of Potential Cancer Risk With Weight Loss Drug
  • USA – La compagnie de tests génétiques 23andMe a développé un médicament grâce à l’ADN de ses utilisateurs
  • USA – FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study Complete
  • USA – More drugmakers recall nizatidine, ranitidine products over cancer risk
  • USA – FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports
  • UK – Complex Cancer Trials: Group of UK Experts Offers Recommendations
  • France – Levothyrox : l’ancienne formule ne sera plus commercialisée à partir de septembre
  • USA – NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses
  • Asia – The Essential List of Regulatory Authorities in Asia
  • USA – New Guidance Explains How Regulators Can Begin the Process to Join PIC/S
  • USA – FDA Updates Compliance Guide on Pre-approval Inspections for Drugs
  • UK – Examining the issue formerly known as Brexit
  • Europe – Le supplément 10.2 de la Pharmacopée Européenne est disponible
  • India – Indian drugmaker receives warning letter from FDA
  • USA – FDA: 2019 Continues Uptick in Orphan Drug Approvals
  • USA – FDA drug approvals declined last year
  • UK – NICE refuses Akcea’s Waylivra
  • UK – Tecentriq hit with draft NICE rejection
  • USA – FDA issues draft guidance on communications with combo product developers
  • Europe – Après les sartans, la metformine et la ranitidine et d’autres substances actives, produites par synthèse chimique, contaminés, la recherche de nitrosamine dans tous les médicaments devient obligatoire
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  • Europe – Révision du chapitre général 5.8 sur l’harmonisation des pharmacopées
  • USA – FDA Drafts Guidance on Demonstrating Substantial Evidence of Effectiveness
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  • USA – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act
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  • USA – Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers
  • USA – FDA enhances DDT qualification pathway for biomarkers
  • UK – NICE u-turn backs NHS use of Veltassa
  • USA – US Biosimilar Launches About to Turn a Corner
  • USA – Draft Guidance : Qualification Process for Drug Development Tools
  • Europe – Comparability considerations for Advanced Therapy Medicinal Products : Q & A
  • India – Food or drug? Government to take a call soon
  • Australia – Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
  • Finland – Finland Prepares for 2020 Introduction of new Clinical Trial Regulations
  • USA – FDA issues draft guidance to foster oncology product development for pediatric populations
  • Europe – Guidelines on good pharmacovigilance practices (GVP)
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  • USA – FDA slams repackager for unsupported drug expiration dates
  • USA – FDA Testing Levels of Carcinogen in Diabetes Drug Metformin
  • USA – US FDA issues Drug Master File draft guidance for industry, Indian pharma sees immense value
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  • Europe – EMA update on metformin diabetes medicines
  • Europe – PRAC recommendations on safety signals : Expected publication dates
  • USA – Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment
  • USA – FDA Debates Creating Pilot to Evaluate Novel Excipients
  • Europe – 9 nouveaux étalons de référence de la Ph. Eur. et 20 lots de remplacement libérés en novembre 2019
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  • Europe – European authorities working to avoid shortages of medicines due to Brexit – Q & A
  • USA – FDA could release drug importation plan in January
  • USA – FDA issues final guide on adaptive trial designs for drugs, biologics
  • Europe – EC Explains What it Means to Authorize Clinical Trials With Conditions
  • UK – NICE grants Lynparza expansion for advanced ovarian cancer
  • USA – Adaptive Designs for Clinical Trials of Drugs and Biologics
  • Europe – EMA Subgroup Questions Use of NBs to Assess Companion Diagnostics
  • UK – NICE approves Ibrance via Cancer Drugs Fund
  • Europe – CMDh : Generic Applications – Questions & Answers
  • Europe – CMDh : Best Practice Guide on Multilingual Packaging
  • Europe – CMDh : Homeopathic Medicinal Products – Questions & Answers
  • UK – Mavenclad granted accelerated access by NICE
  • Europe – PRAC recommendations on signals : 28-31 October 2019 meeting
  • USA – FDA Updates its Thinking on Immunogenicity Studies for Insulin Biosimilars, Interchangeables
  • USA – FDA : Certificates of Confidentiality
  • USA – FDA Releases 81 Product-Specific Guidances
  • Europe – Brexit Costs EMA Almost €60M in 2019
  • USA – Draft Guidance : Transdermal and Topical Delivery Systems – Product Development and Quality Considerations
  • Europe – Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet
  • Europe – EC Offers Help to Wholesalers on GDP Inspections
  • USA – Considerations in Demonstrating Interchangeability With a Reference Product
  • USA – Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act
  • USA – Nonproprietary Naming of Biological Products
  • USA – Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry
  • Europe – Ex ante publicity of a negotiated procedure EMA/2019/40/LD – Legal advice in relation to procurement matters and contracts under EU procurement and Dutch law
  • Pakistan – Pakistan’s DRAP Creates Guidelines on Conducting Clinical Trials
  • Europe – Duplicate marketing authorisations for biological medicinal products
  • USA – Labeling for Biosimilar Products
  • France – Update : Antimicrobial resistance
  • USA – Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry
  • Europe – EMA : Mid-year report 2019
  • Europe – EU Health Group Raises Concerns About Delays to Clinical Trial Portal and Database
  • UK – NICE ‘OK’ for Sativex in MS
  • Europe – IRIS guide to the Industry portal
  • Europe – EC Offers Further Clarity on Clinical Trial Regulation
  • Europe – Consultation publique de la Pharmacopée Européenne sur le chapitre général 2.4.20. Dosage des impuretés élémentaires
  • USA – Researchers Call on FDA to Rethink Guidance Allowing Use of Surrogate Outcomes
  • UK – NICE recommends Elmiron for bladder pain syndrome
  • TGA Creates Advertising Guidance for Providers of Cell and Tissue Products
  • New Zealand – New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels
  • USA – Experts Pitch FDA on Policies to Improve Drug Development
  • UK – NICE U-turn for Epidyolex in epilepsy
  • Europe – Administration de médicaments : la Suisse devient le pays d’Europe le plus innovant Publié le 08 novembre 2019 par Patrick RENARD
  • Europe – CAT monthly report of application procedures, guidelines and related documents on advanced therapies
  • Switzerland – Swissmedic Details Plans to Align Combination Product Rules With EU
  • Europe – Trade Group Calls for EU to Cut Review Times for ATMP Clinical Trial Filings
  • Europe – 7 new reference standards and 23 replacement batches released in October 2019
  • Europe – Update : ”Blue – Box” requirements
  • UK – The return of NICE international
  • USA – Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff : Draft Guidance
  • Australia – TGA Creates Guidance on Difference Between Disease Education and Drug Promotion
  • Pakistan – Pakistan Posts Draft Accelerated Approval Guidelines in Flurry of Activity
  • Europe – Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
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  • USA – Trump Nominates Hahn to be FDA Commissioner
  • Australia – Advertising guidance for businesses involved with medicinal cannabis products
  • USA – Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry : Draft Guidance
  • USA – Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 : Draft Guidance
  • USA – Drug Shortages: Root Causes and Potential Solutions
  • Europe – EudraVigilance registration documents for Production
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  • USA – Supporting Drug Development Through Physiologically Based Pharmacokinetic Modeling
  • Europe – EudraVigilance Release Notes v.1.21
  • USA – Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics
  • USA – FDA Task Force Recommends Rating System for Drug Manufacturing Quality
  • USA – Developing the Tools to Evaluate Complex Drug Products: Peptides
  • USA – Finding a Better Test for Predicting the Risk Drugs Pose to the Heart
  • USA – Developing New Ways to Evaluate Bioequivalence for Topical Drugs
  • USA – Guidance : Providing Regulatory Submissions in Electronic Format – IND Safety Reports
  • Europe – PRAC recommendations on signals
  • USA – FDA Drafts Guidance on Type V DMFs for Combination Products
  • USA – Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format : Lot Release Protocols
  • USA – Addressing Concerns About the Quality of Generic Drugs for Treating Epilepsy
  • Europe – The role of members representing patients’ and healthcare professionals’ organisations on EMA Scientific Committees
  • Europe – European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
  • Europe – European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
  • UK – NICE considering re-evaluation of quality of life assessment
  • USA – Drugmakers Make Significant Headway in Track-and-Trace Compliance
  • USA – Risk Evaluation and Mitigation Strategies: Modifications and Revisions
  • USA – Implementation of Section 505(o)(3) – Postmarketing Studies and Clinical Trials
  • USA – FDA’s efforts to protect patients from potentially harmful drugs sold as homeopathic products
  • USA – Guidance : Child-Resistant Packaging Statements in Drug Product Labeling
  • USA – Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment
  • Malaysia – Malaysia Provides Guidance on Regulatory Control of Atypical APIs
  • China – Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies
  • USA – Submitting Manufacturing Facility Information: Final FDA Guidance
  • Europe – Mandate, objectives and rules of procedure for the Name Review Group (NRG)
  • Europe – Requesting and receiving EMA certificates through urgent and standard procedure from November 2019 to January 2020 : Notification
  • USA – Newly Added Guidance Documents
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  • Euroope – EMA Issues Guide on Consistency of Indication Wording
  • USA – FDA Revises 1989 Guidance on Drug Master Files
  • France – ANSM : Accès à l’innovation thérapeutique, l’ANSM pérennise ses circuits accélérés d’autorisation d’essais cliniques de médicaments dits « fast-track »
  • UK – NICE ‘ok’ for Bayer’s Xarelto
  • UK – UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup
  • UK – Updated guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal
  • USA – FDA Finalizes Guidance on PDUFA Fee Waivers, Reductions and Refunds
  • Europe – EC Publishes New Guidelines on Good Clinical Practices for ATMPs
  • Europe – ICH Q3C (R6) Residual solvents
  • New Zealand – Medsafe Clarifies Process for Extending the Shelf Life of Reference Standards
  • USA – What’s New in Regulatory Science
  • Europe – EudraLex – Clinical trials guidelines – Volume 10
  • USA – Researchers Find 15% of Trials Could be Replicated Using Real World Data
  • UK – Increased discount leads NICE to reverse positon on Clovis cancer drug
  • UK – Elmiron bags draft NICE approval
  • Europe – Supplément 10.1 de la Ph.Eur. Les titulaires de CEP sont invités à mettre à jour leurs dossiers
  • UK – Importing medicines from the EEA after Brexit
  • UK – Licensing biosimilars, ATMPs and PMFs after Brexit
  • UK – How the MHRA will manage UK orphan medicinal products after Brexit
  • UK – Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, ‘grandfathering’ and managing lifecycle changes
  • Europe – The Eur. Ph. : pioneer of good health in Europe. “Memories of a European pharmacist” by Fernand Sauer
  • USA – FDA Unveils New Tables for Submitting Bioanalytical Methods
  • France – Médicaments : le G5 appelle le gouvernement à « changer de doctrine »
  • Europe – 15 new reference standards and 16 replacement batches released in September 2019
  • China – Chinese biotech firm raises nearly $28M in Series B round
  • UK – Medicines that cannot be parallel exported from the UK
  • France – L’ANSM met en place un « fast-track » pour les produits innovants et dématérialise les procédures
  • UK – Variations to Marketing Authorisations (MAs) after Brexit
  • UK – ABPI details Brexit plans at PIPA conference
  • UK – NICE draft ‘no’ for Roche’s Tecentriq
  • Europe – When Can RWE Translate Into Credible Evidence? EMA Officials Discuss
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  • Europe – Report from the CMDh meeting held on 17-19 September 2019
  • USA – FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels
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  • France – Le Leem demande un moratoire sur les baisses de prix – PLFSS 2020
  • Switzerland – Swissmedic Takes Position on Fast-Track Reviews of Tissue-Agnostic Drugs
  • Europe – EMA Releases EudraVigilance List of Important Medical Event Terms
  • Europe – EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance and trusted deputy
  • UK – Sunset clause: request for public health exemption
  • UK – Applying for a Certificate of Pharmaceutical Product after Brexit
  • Europe – EMA EudraVigilance Registration Manual
  • UK – NICE delivers final ‘no’ for Novartis’ migraine treatment Aimovig
  • UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit
  • USA – New MAPP Offers Insight Into Patient-Oriented Labeling Consultations for Combination Products
  • USA – Genital herpes vaccine candidate heads for human studies
  • Switzerland – La Suisse valide l’utilisation du cannabis à des fins médicales
  • India – Indian regulators to put all drug approvals online
  • France – Le Professeur Fourtillan refuse de mettre un terme à ses travaux
  • USA – FDA Compiles List of NDAs Transitioning to BLAs Next March
  • Australia – TGA Adopts Risk-Based Model for Fecal Microbiota Transplants
  • Europe – Un médicament à base de cannabis indiqué dans deux épilepsies infantiles autorisé en Europe et en France
  • USA – FDA Finalizes ALS Drug Development Guidance
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  • UK – Takeda’s HAE drug Takhzyro backed by NICE
  • USA – FDA’s Comprehensive Response to HIV — Part I
  • Europe – Inclusion/exclusion criteria for the “Important Medical Events” list
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  • France – Un essai clinique mené sans autorisation chez des patients atteints des maladies de Parkinson et d’Alzheimer interdit par l’ANSM
  • UK – NICE recommends Takhzyro
  • UK – Biological medicine quality to receive major boost
  • USA – FDA Explains Plans for New Pharmaceutical Quality Assessment System
  • USA – FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development
  • UK – NICE, PHE publish antimicrobial prescribing guidance on pneumonia
  • Europe – Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’
  • USA – When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates
  • Europe – EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante
  • Europe – Vaccination: European Commission and World Health Organization join forces to promote the benefits of vaccines
  • UK – NICE approves BioMarin’s Brineura after initial setback
  • Europe – EMA : Preparedness of medicines’ clinical trials in paediatrics
  • Pakistan – After WHO Acceptance, Pakistan Drafts Pharmacovigilance Guidelines
  • USA – FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs
  • USA – FDA asks drug, biologics makers to use UCUM in electronic submissions
  • Europe – Spravato reduces depressive symptoms in 24 hours
  • USA – FDA approvals of new cancer drugs have doubled in this decade
  • USA – Cloud-based tracking system monitors drug adherence
  • USA – FDA Offers Advice on Extrapolating Efficacy of Seizure Drugs from Adults to Children
  • Europe – Ph. Eur. 10th Edition – Now available!
  • UK – NICE nod for Novartis’ Luxturna
  • UK – Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit
  • UK – NICE publishes draft cerebral palsy quality standard
  • Europe – European Medicines Agency active-substance-master-file-number request form
  • China – China reduces penalties on unapproved drug imports
  • USA – Le ciseau génétique CRISPR pourrait permettre de créer des médicaments qui changent de forme
  • USA – FDA says widening probe on generic drug impurities
  • USA – FDA Finalizes Guidance on Placebos and Blinding for Cancer Trials
  • USA – FDA encourages inclusion of male patients in breast cancer clinical trials
  • France – Réforme des ATU : un décret fixe les conditions de remboursement
  • Europe – L’UE annonce une aide de 550 millions d’EUR pour sauver 16 millions de vies menacées par le sida, la tuberculose et le paludisme
  • Europe – EMA : policy on access to EudraVigilance data for medicinal products for human use
  • Europe – Brexit : pas de pénurie de médicaments en vue pour la France
  • Europe – Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
  • India – India to Add EU to List of Regions Covered by Clinical Trial Waiver
  • India – India Seeks Feedback on Mandatory use of QR Codes on API Packaging
  • Europe – EMA : procedural advice for users of the centralised procedure for generic/hybrid applications
  • Europe – EMA : procedural advice for users of the centralised procedure for similar biological medicinal products applications
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  • UK – NICE highlights need for more cannabis-based research
  • UK – NICE backs Keytruda plus chemo as first-line option for lung cancer
  • UK – Guidance on handling of Decentralised and Mutual Recognition Procedures in a no-deal Brexit
  • UK – Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no-deal Brexit
  • UK – Licensing of biological products: biosimilars, ATMPs and PMFs in a no-deal Brexit
  • UK – List of approved countries for authorised human medicines if there is a no-deal Brexit
  • USA – FDA: Novartis used faulty data to seek therapy approval
  • Canada – Canadian drug lobby pushes curbs on exports to US
  • UK – NICE recommends rivaroxaban funding to prevent strokes, heart attacks
  • Australia – Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?
  • USA – New FDA Guidances Target Women’s Health, Neonatal Care
  • Europe – Who’s calling the shots in European healthcare?
  • France – L’ANSM a constitué ses nouveaux comités scientifiques permanents – Point d’Information
  • USA – USP, British Pharmacopoeia Formalize Quality Standards Partnership
  • UK – NICE expands draft recommendation for Lokelma
  • Europe – EudraVigilance Release Notes v.1.20
  • USA – FDA updates draft guidance on rare pediatric disease priority review voucher program
  • Europe – EU Drug Shortage – The Impact of Brexit on Both the UK and EU-27 Member States
  • USA – FDA Finalizes Guidance on Delayed Graft Function in Kidney Transplantation
  • Canada – Guidance Document: Management of Drug Submissions and Applications – Revisions
  • Europe – 25 July 2019 batch release
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  • UK – NICE to form alliance to produce chronic asthma guideline
  • Europe – MA Electronic Submission : New Rules
  • Australia – TGA Updates Guidance on the Testing of Biological Medicines
  • Canada – Canada warns against US drug import proposals
  • USA – FDA Finalizes Combo Product Postmarket Safety Reporting Guidance
  • Europe – A Significant Number of Manufacturers have Failed to Connect to EU Medicines Verification System
  • Europe – CEP holders are invited to update their applications : 10th Edition of Ph. Eur.
  • USA – FDA Offers Technical Specifications for Submitting NGS Data on Antivirals
  • UK – MHRA launches consultation on how to best engage patients and the public
  • Europe – Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines en France
  • USA – FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer
  • USA – Updated Fundamentals of US Regulatory Affairs Book
  • UK – NICE U-turn for Kisqali in breast cancer
  • India – Indian drugmakers form partnerships as they enter the Chinese market
  • USA – FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection
  • Europe – Four new substances added to the Candidate List
  • Europe – Dosage Form Monographs for Public Consultation
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  • Europe – Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs
  • Europe – Le format eCTD est obligatoire pour tous les dossiers de CEP à partir du 1er janvier 2020
  • UK – The Human Medicines and the Medical Devices Regulations 2019
  • UK – AbbVie’s Skyrizi gets rapid ‘yes’ from NICE
  • USA – Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations
  • USA – FDA Revises 1999 Draft Guidance on Population Pharmacokinetics
  • UK – Implementing the Falsified Medicines Directive: Safety Features
  • Australia – Updates to variations to prescription medicines guidance and e-form
  • UK – Development of new antibiotics encouraged with new pharmaceutical payment system
  • France – Frédéric Collet élu à la présidence du Leem
  • France – HAS : Toutes nos publications par thèmes – Recommandations, médicaments, actes, dispositifs, …
  • USA – FDA Finalizes Revised REMS Modifications Guidance
  • UK – NICE Onpattro approval puts Alnylam back in hATTR running
  • Europe – EU invests €35 million to develop Artificial Intelligence solutions for cancer prevention and treatment
  • USA – FDA announces public health emergency prioritization of ANDAs for drug products for the emergency treatment of opioid overdose
  • Europe – Withdrawal of the United Kingdom and EU Rules in the Field of Good Laboratory Practice (GLP)
  • Europe – Annex 2: HaRP (Harmonisation of RMP Project) – methodology of harmonising RMPs
  • UK – AZ to appeal NICE rejection for lung cancer drug
  • Europe – Europe urged to adapt faster to gene therapy challenges
  • Europe – PRAC recommendations on signals
  • UK – NICE OK for life-extending Vizimpro in lung cancer
  • Canada – Risk Management Plans – Notice of clarification to drug manufacturers and sponsors
  • Europe – Medicine Shortages: EU Network takes steps to improve reporting and communication
  • India – India Proposes Making Marketers Responsible for Drug Product Quality
  • Europe – Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate
  • Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health
  • UK – NICE approves CDF funding for Sanofi’s Libtayo
  • UK – Brexit Select Committee Hearing – Impact on the Pharmaceuticals Industry
  • China – Health leaders see fast growth in China pharma, biotech
  • USA – Drugmakers to electronically file promo materials for fast-track drugs
  • UK – Medicines and medical products supply: government updates no-deal Brexit plans
  • UK – Research supports better integration of patient voice in health technology assessments
  • UK – DHSC : Letter to Suppliers – Continuity of supply of medicines and medical products in 31st October no-deal EU exit scenario
  • USA – FDA Drafts Two New Guidances on Drug Labeling
  • USA – CBER Plans Draft Guidance on ‘Sameness’ of Gene Therapies Under Orphan Drug Regulations
  • UK – NICE pushes social prescribing for dementia
  • USA – FDA developing new guidance on opioid risk-benefit assessments
  • USA – FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics
  • Europe – Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency
  • UK – NICE publishes draft guidance on adult leg ulcers
  • China – Chinese regulators hope to increase the number of generic drugs
  • UK – NICE hops on real world data trend to inform guidance
  • USA – FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines
  • UK – Innovative treatment for inflammatory eye condition recommended for use on the NHS
  • UK – Brexit Select Committee Hearing – Impact on the Pharmaceuticals Industry
  • UK – EU Exit preparedness
  • USA – Legislation would facilitate generic drug entry, raise tobacco-buying age
  • USA – « Research Investigational New Drug Applications – What You Need To Know » June 25, 2019 Issue
  • Europe – EC Aide-Memoire Aims to Help Drugmakers Comply With GMP Inspections Related to Falsified Medicines Delegated Regulation
  • USA – FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition
  • Australia – Australia Preps for Medicine Ingredient Name Changes
  • Europe – ECHA to scrutinise all REACH registrations by 2027
  • USA – FDA Finalizes Guidance on Advertising and Promotional Material Submissions
  • Canada – New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD)
  • USA – FDA program to respond to questions from stem cell therapy developers
  • USA – Iran, Argentina Join International Drug Regulators Group
  • USA – FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones
  • Europe – Management Board supports efforts to improve REACH authorisation and evaluation
  • UK – Drug Safety Update: monthly PDF newsletter
  • UK – NICE nod for Blincyto
  • USA – FDA : Statement on a new effort to improve transparency and predictability for generic drug applicants
  • UK – NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations
  • Europe – Update on the EDQM review of CEP applications for sartans and next steps (June 2019)
  • France – Androcur® : des patients mieux informés sur le risque de tumeur du cerveau
  • France – Sanofi et Google renforcent leur partenariat dans l’e-santé
  • Europe – Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure
  • Europe – EMA activities, other than the highest priority activities (category 1 activities), that will continue in 2019
  • USA – FDA approves new treatment for pediatric patients with type 2 diabetes
  • UK – ABPI publishes new guidelines on pharma working with patients
  • USA – FDA, USP Clash Over Biologics Monographs
  • USA – Drugmakers Sue HHS for Trying to Add Prices to DTC Ads
  • UK – MHRA Offers Advice on use of Brand Names to Prescribe Drugs
  • Europe – General chapter 5.8 Pharmacopoeial harmonisation: new concept for the Ph. Eur. 10th Edition
  • Europe – Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs
  • Canada – Statement on the Investigational Use of Marketed Drugs in Clinical Trials
  • China – China to tighten rules on foreigners using genetic material
  • Europe – Brexit sans accord: la Commission européenne fait le point sur les préparatifs avant le Conseil européen (article 50) de juin
  • Australia – Therapeutic goods advertising: Ensuring ‘natural’ claims are not misleading
  • USA – FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations
  • USA – CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis
  • Switzerland – Switzerland to Publish Pharmacopoeia for Free Online for the First Time
  • China – How trade war with China could hit US pharmaceutical makers
  • Europe – Member states contact points for translations review
  • USA – Current Good Manufacturing Practice for Medical Gases Guidance for Industry
  • Canada – Product Monograph Brand Safety Updates
  • USA – Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products
  • Europe – Recommendations on eligibility to PRIME scheme
  • USA – FDA to roll out patient access program to cancer drugs
  • UK – UK discourages use of paclitaxel devices for intermittent claudication
  • Europe – Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
  • USA – FDA Wins Federal Court Case Against Stem Cell Clinics
  • Europe – Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications
  • Europe – List of centrally authorised products requiring a notification of a change for update of annexes
  • Europe – EudraVigilance Release Notes v.1.19
  • UK – Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines
  • Europe – EDQM inspections and trends of GMP deficiencies: Overview 2006 to 2018 (PA/PH/CEP(18) 56 April 2019)
  • UK – NICE issues guidance revision for depression
  • UK – NICE recommends MSD’s PREVYMIS®within licensed indication
  • USA – FDA Should Reassess Postmarket Trials for Cancer Drugs Approved via Accelerated Pathway, Researchers Say
  • India – CDSCO Creates Process for Companies That Lack Data Supporting Their FDCs
  • Europe – Etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day product-specific bioequivalence guidance
  • USA – FDA Approves First NDA Under Real-Time Oncology Review Pilot
  • South Korea – EU regulators approve export of active ingredients from S. Korea
  • USA – What’s the Latest in Drug-Delivery Devices?
  • USA – FDA approves first PI3K inhibitor for breast cancer
  • UK – Final NICE guidance issued for Akcea’s Tegsedi
  • USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming
  • USA – FDA Chief of Staff Calls OTC Monograph Reform a Top Priority
  • USA – FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations
  • USA – FDA Officials Explain When Litigation Can Impact Drug Safety Signals
  • UK – UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation
  • USA – FDA opening call center for access to unapproved cancer drugs
  • USA – Fragmin approved by FDA as first anticoagulant for children
  • UK – Exporting active substance manufactured in the UK in a no deal scenario
  • USA – NIH releases interactive data browser for precision medicine research
  • USA – FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India
  • UK – After discount row, NICE finally says yes to first line Revlimid
  • USA – Reassessing Benefit-Risk: FDA Preps for New Guidance
  • Canada – Performance Standards for the Fees in Respect of Drugs and Medical Devices Order
  • USA – FDA Unveils 34 New and Revised Product-Specific Draft Guidances
  • South Korea – European Commission Confirms Quality of South Korean Active Substances
  • UK – NICE recommends Sprinraza for 5q spinal muscular atrophy
  • Canada – Santé Canada propose d’accélérer l’approbation de certains médicaments pour cas rares
  • USA – MAPP Describes the Work of CDER’s Biopharmaceutics Council
  • UK – Potential first ever targeted therapy designed for ‘untreatable’ childhood brain cancer
  • USA – Interchangeable Biosimilars: FDA Finalizes Guidance
  • USA – When to Submit an ANDA vs. a 505(b)(2)? FDA Explains
  • USA – FDA Finalizes Maximal Usage Trials Guidance for Topical OTC Drugs
  • USA – Evaluating Reproductive Toxicity in Oncology Drugs: FDA Finalizes Guidance
  • Europe – Brexit « having impact on EU drug development”
  • USA – Studying Drugs in Pregnant and Nursing Women: FDA Issues Draft Guidances
  • USA – RWE Submissions: FDA Drafts Guidance
  • USA – List Prices in Drug Ads on TV Coming as CMS Finalizes Rule
  • USA – FDA to Study DTC Ads for Drugs Approved Under Accelerated Process
  • Europe – EMA : Working together for safe medicines in the EU
  • USA – FDA Drafts Guidance for Developing Drugs to Treat ADHD
  • Canada – Release of Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs)
  • Europe – Sartans Article 31 referral – CHMP assessment report
  • UK – NICE recommends Roche’s Tecentriq for metastatic NSCLC
  • Europe – Widespread Concern Over Europe’s Uncertain Regulatory Future Highlights Region’s Importance
  • USA – Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements December 2018
  • USA – Guidance, Compliance & Regulatory Information (Biologics)
  • USA – Framework for the Regulation of Regenerative Medicine Products
  • USA – FDA Adds Boxed Warnings to Insomnia Medicines Following Injuries, Deaths
  • China – CDE Shares Chinese Medicine Clinical Research Guidelines for Consultation
  • India – India Posts Guide to Revised Rules on New Drugs and Clinical Trials
  • USA – FDA Drafts Guidance on Adjusting for Covariates in Randomized Trials
  • Europe – Draft ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines – Overview of comments received
  • USA – FDA issues final rule on OTC hand sanitizers
  • UK – NICE final guidance published for Cimzia
  • Europe – Registered substances mapped for regulatory action
  • Canada – Health Canada Opens Generic Drug Guidances for Consultation
  • Europe – EMA Enters Into Information-Sharing Agreement With EU Quality Body
  • Switzerland – Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans
  • France – ANSM : Répertoire des médicaments génériques -Avril 2019
  • UK – Novartis’ Kisqali hit with NICE rejection
  • USA – FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
  • Asia – New pharmaceutical company launches in Asia
  • India – Generic breast cancer drug coming to India
  • UK – NICE appraisal for BMS kidney cancer immunotherapy combination
  • USA – When a REMS is Necessary: FDA Finalizes Guidance
  • USA – FDA Identifies ARBs Without Impurities
  • UK – MHRA Offers Additional No-Deal Brexit Guidance
  • Europe – Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines
  • Australia – TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals
  • France – Lipidots : des cargos moléculaires pour la délivrance de médicaments
  • USA – Revocation of the Test for Mycoplasma
  • UK – NICE nod for Lilly’s breast cancer drug Verzenio via CDF
  • UK – BREXIT : où en est-on ?
  • Europe – BREXIT : Fiches d’information et FAQ
  • Europe – Symposium EDQM-USP : les différentes utilisations des étalons de référence de pharmacopée
  • UK – NICE green light for Imfinzi in groundbreaking early lung cancer treatment
  • USA – Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling Guidance for Industry
  • Europe – European authorities working to avoid shortages of medicines due to Brexit – Questions and answers
  • India – Indian regulators waive clinical trials for drugs approved elsewhere
  • UK – NICE recommendation for Steglatro in type II diabetes
  • Europe – European Panel Offers Advice on Complex Drug Trials
  • USA – FDA Promises Flexibility for Stem Cell Trials
  • USA – Natural History Studies for Rare Diseases: FDA Drafts Guidance
  • UK – NICE nod for Takeda’s Adcetris in advanced stage CTCL
  • UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices
  • USA – FDA Finalizes Two Guidances on HIV Drug Development
  • UK – A Right Royal Deadlock: Can « Crown » use unlock patented drug?
  • USA – FDA suggests letting more patients with viral infections into cancer clinical trials
  • USA – Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products Guidance for Industry
  • Europe – ICH M10 on bioanalytical method validation
  • USA – FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility
  • China – China may launch trials on new gene-editing technology within 2 years
  • UK – NICE u-turn backs use of Darzalex combo for myeloma relapse
  • UK – UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines
  • Europe – EMA now operating from Amsterdam
  • UK – NICE nod for Almirall’s Ilumetri, UCB’s Cimzia
  • Europe – Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials
  • UK – NICE updates high blood pressure guidelines
  • China – China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal
  • UK – Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal
  • UK – Delays to cancer testing and treatment ‘inevitable’ after Brexit
  • USA – FDA approves new nasal spray medication for treatment-resistant depression
  • UK – NICE evidence request for Blincyto for acute lymphoblastic leukaemia
  • USA – FDA Finalizes Guidance on 503B Bulks List
  • Europe – EMA Closes London Office, Preps for New Time Zone
  • Europe – Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products
  • Europe – Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation – Overview of comments received
  • UK – How to make submissions to the MHRA if the UK leaves the EU with no deal
  • India – India Advances Plan to Create Mobile Drug Testing Laboratories
  • UK – Roche Wins Approval for Perjeta in Breast Cancer Subgroup
  • USA – Generic Drugs: FDA Releases 74 Product-Specific Guidances
  • Europe – Les eaux à usage pharmaceutique : principes de production et critères de la Ph. Eur.
  • Europe – EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials
  • UK – Brineura hit with NICE rejection
  • Germany – BfArM’s recommendations regarding clinical trials with medicinal products where sponsor or legal representative are established in the United Kingdom
  • UK – UK Offers No-Deal Brexit Guidance for Biologics Manufacturers
  • Europe – Le droit de la concurrence comme vecteur de l’accès à des médicaments abordables et innovants en Europe
  • UK – Report finds NICE’s routine appraisals need reform
  • India – Indian regulators tweak drug trial rules
  • USA – Regenerative Medicines: FDA Finalizes Guidance on Expedited Programs
  • UK – Widening the availability of naloxone
  • Europe – EMA suspends fenspiride medicines due to heart rhythm risks
  • UK – Alunbrig recommended by NICE for non-small-cell lung cancer
  • UK – NICE changes its mind on Perjeta
  • USA – Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds
  • UK – New NICE guidelines on antibiotic prescribing for pneumonia
  • UK – New ‘Trojan horse’ cancer treatment shows early promise
  • UK – ABPI warns of greater exposure to fake meds under no-deal Brexit
  • France – Sérialisation : une sécurité des médicaments renforcée
  • Australia – Australia Looks to Improve Generic Drug Authorization Process
  • Europe – Guideline on clinical investigation of medicinal products for the treatment of gout
  • Europe – Implementing the Falsified Medicines Directive: Safety Features
  • Europe – Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3
  • USA – FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder
  • USA – FDA Finalizes Buprenorphine Drug Development Guidance
  • Europe – L’Italie saisit la justice européenne sur la relocalisation de l’Agence du médicament à Amsterdam
  • UK – Mapping of oesophageal cancer gene mutations leads to new drug targets
  • USA – USP’s Generics Access Plan to Aid FDA Efforts
  • USA – FDA Announces Plans for Advancing Cell and Gene Therapies
  • UK – Kymriah gets NICE approval for DLBCL
  • Europe – Guide technique pour l’élaboration des monographies de vaccins et sérums pour usage humain – Mise à jour
  • USA – Marketing Status Notifications: FDA Drafts Guidance
  • Europe – UK and Russia sign MoU on Regulatory Cooperation on Medicines
  • Europe – Novartis urges government to ‘minimise disruption’ in no-deal Brexit
  • USA – FDA Issues Draft Guidance on Tentatively Approved ANDAs
  • Europe – Shire Raises ‘Substantial Concerns’ About ICH Guidelines in Feedback to EMA
  • UK – How to make regulatory medicines submissions to the MHRA if the UK leaves the EU with no deal
  • Australia – TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP
  • UK – NICE backs digital CBT for mildly depressed children and young people
  • USA – FDA Offers ICH S11 Guidance for Comment as Shutdown Threatens Further Guidance
  • USA – FDA Finalizes Accelerated Approval Labeling Guidance
  • Europe – Supplément Ph. Eur. 9.8: les titulaires de CEP sont invités à mettre à jour leurs dossiers
  • Europe – EMA issues draft guidelines on antibiotic studies
  • UK – Trivalent gets UK green light for flu in over 65s
  • UK – NICE endorsement means more donor livers could be used for transplantation
  • USA – FDA Drafts Guidance on Tentatively Approved ANDAs
  • USA – FDA Revises Draft Guidance on Rare Diseases
  • UK – NICE approval for Verzenios in metastatic breast cancer
  • UK – Venetoclax gets NICE approval for chronic lymphocytic leukaemia
  • UK – NICE OK for Bravtovi skin cancer drug
  • Europe – Europe closer to biosimilar rule change, despite fierce resistance from pharma
  • USA – FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices
  • Australia – TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data
  • Europe – Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods
  • Europe – Evaluation of anticancer medicinal products in man : Concept paper on the revision of the guideline
  • USA – Lilly CEO on future cancer deals, gene therapy and CAR T-cells
  • Europe – Solution concentrée d’infliximab : première monographie d’anticorps monoclonal dans la Ph. Eur.
  • Europe – Produits biothérapeutiques vivants (PBV) : exigences de qualité sans précédent fixées par la Commission
  • UK – Good pharmacovigilance practice
  • UK – NICE says Novartis’ migraine drug Aimovig too costly for NHS
  • USA – Gottlieb describes Innovation Office, Biosimilars Policies at JPM
  • Europe – Guidance for marketing authorisation transfer – National requirements
  • UK – Stivarga final NICE recommendation for hepatocellular carcinoma
  • Europe – Renforcement de la coopération entre les pharmacopées européenne et indienne
  • UK – Implementing the Falsified Medicines Directive: Safety Features
  • Europe – EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals
  • USA – Drug Sponsors Urge FDA to Think Bigger About Master Protocols
  • UK – NICE approves Xeljanz for Ulcerative Colitis
  • UK – AstraZeneca wins NICE backing for asthma injection
  • UK – MHRA responds to consultation on Brexit no-deal proposals
  • USA – FDA updates endpoint guidance for cancer trials
  • UK – NICE recommends Lenvima for advanced liver cancer
  • UK – NICE publishes updated guidance with expanded recommendation for Oncotype DX
  • Europe – Update on the review of CEP applications for sartans
  • USA – FDA Revises Guidance on Oncology Endpoints
  • UK – EU & NICE authorise MSD’s Keytruda for stage III melanoma
  • Europe – Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)
  • USA – FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices
  • USA – Drugmakers Call for Clarification of FDA’s Postapproval Change Guidance
  • Europe – Guideline on Active Substance Master File Procedure
  • UK – NICE appraisal fees to be introduced despite opposition
  • Europe – Draft guideline on quality and equivalence of topical products
  • USA – FDA Withdraws Proposed Rule on Generic Label Changes
  • Europe – Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
  • UK – NICE rejects NHS funding for Tegsedi, Onpattro
  • USA – Definition of the Term “Biological Product”
  • Europe – Nouvelle ligne directrice de l’EDQM « Comment lire un CEP »
  • New Zealand – New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections
  • UK – Pharma calls for more detail on plan for post Brexit meds access
  • UK – NICE turns down Opdivo/Yervoy combo for kidney cancer
  • USA – FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says
  • UK – NICE OKs NHS funding for Gilead’s CAR T-cell therapy
  • Europe – Détection d’impureté dans le valsartan : les mesures prises par l’EDQM ces dernières semaines
  • Europe – EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals
  • UK – NICE backs Cimzia for psoriasis, but rejects Ilumetri
  • USA – FDA Issues Draft Guidance on NASH Drug Development
  • USA – Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances
  • Europe – Update on the review of CEP applications for sartans
  • Europe – Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products
  • UK – Immunotherapy extends the life of head and neck cancer patients
  • UK – NICE u-turn on Opdivo for skin cancer recurrence
  • International – How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?
  • UK – Bayer’s Stivarga wins NICE backing for advanced liver cancer
  • USA – New Product-Specific Guidances Focus on Drugs Without Generic Competition
  • Europe – Reflection paper on the qualification of non-genotoxic impurities
  • France – Médicaments : rapport sur le progrès thérapeutique, édition 2018
  • Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668)
  • Europe – Reflection paper on regulatory requirements for the 5 development of medicinal products for chronic non6 infectious liver diseases (PBC, PSC, NASH).
  • Europe – Update on the review of CEP applications for sartans
  • Europe – Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract
  • Europe – Guideline on the quality of water for pharmaceutical use
  • UK – NICE issues final draft guidelines for Novartis’ Kymriah
  • France – Médicaments : une évaluation rigoureuse et scientifique par la HAS
  • USA – FDA touts record-breaking number of October generic approvals
  • UK – Final NICE green light for Pfizer’s Mylotarg
  • USA – FDA Drafts Guidance on Using Metastasis-Free Survival Endpoints in Prostate Cancer Posted 13 November 2018 | By Ana Mulero
  • Japan – Stem cell-based Parkinson’s therapy tested in Japan
  • USA – New drug options, risk factors added to U.S. heart guidelines
  • France – L’ANSM met en place un dispositif accéléré d’autorisation d’essais cliniques (Fast Track)
  • USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program
  • UK – NICE says no to expanding use of AZ’ Lynparza
  • UK – Industry Finds Fault With UK Vision for Drug Regulation After Brexit
  • UK – NICE nod for Jazz’ AML chemo
  • USA – FDA Issues Guidance on Dried Plasma Products for Blood Transfusions
  • Europe – Organs, Tissues and Cells – Technical Guides
  • USA – Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance
  • China – China Creates Guidance to Fast Track Important Drugs Approved Overseas
  • Europe – EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India
  • USA – Hepatitis B Virus Drug Development: FDA Offers Draft Guidance
  • USA – Vanda Lands OPDP Warning Letter Over Risk Info on Website
  • UK – Supply unlicensed medicinal products (specials)
  • UK – NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer
  • Europe – EMA’s Rasi on Genome Editing: Time to Move Forward
  • UK – AbbVie’s Venclyxto hit with NICE rejection
  • UK – AbbVie’s Venclyxto hit with NICE rejection
  • UK – NICE turns down hyperkalaemia therapies
  • USA – FDA Finalizes Testicular Toxicity Guidance
  • USA – FDA Approves Anti-Flu Pill – First New Treatment in Nearly 20 Years
  • USA – Verification Systems: FDA Drafts Guidance on What to Include
  • France – Alcoolisme : le baclofène autorisé sous certaines conditions
  • USA – FDA Explains How to Craft a Data Management Plan
  • China – China Charges Vaccine Manufacturer $1.3B for Quality Failings
  • UK – NICE rejects Lilly’s breast cancer drug Verzenios
  • USA – La FDA (Food and Drug Administration) approuve la première pilule numérique
  • UK – NHS set to save £150 million by switching to new versions of most costly drug
  • USA – Oncologists’ Off-Label Prescribing Pits Access Against Reimbursement
  • China – China approves 17 anti-cancer drugs for medical insurance coverage
  • Europe – EMA/EDQM Find Major Deviations at China Manufacturer Embroiled in Valsartan Contamination
  • UK – XLH patients to get routine access to first new therapy in 30 years
  • USA – Complex Generic Drugs: FDA Offers Two Draft Guidances
  • Europe – Falsified Medicines Directive: Implications for parallel importers and of Brexit
  • USA – The First FDA-approved Digital Pill – What It Means for Pharma
  • UK – Gilead strikes deal with NHS England on Yescarta access
  • South Korea – S. Korean officials extend seasonal flu vaccine to very young children
  • USA – Atopic Dermatitis: FDA Finalizes Guidance on Timing of Pediatric Studies
  • USA – Citizen Petitions: FDA Revises Guidance to Block Drugmakers From Abusing the System
  • Europe – EU nod for Lilly’s new breast cancer drug
  • Europe – UK launch for Alliance’s pregnancy anti-nausea and vomiting drug
  • USA – FDA Warns of Dosing Errors With Compounded Injectables
  • USA – Clinical Trials: FDA Releases Two Draft Guidances
  • USA – US green light for Pfizer’s lung cancer drug
  • Europe – Draft NICE decision rejects Respreeza for incurable, genetic disorder
  • Europe – High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin
  • Europe – NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma
  • China – Takeda gets China’s approval for $62 billion Shire purchase
  • Europe – NICE nod for Novartis’ targeted skin cancer combo
  • USA – US approves AZ’ hairy cell leukaemia drug
  • China – Chinese API Manufacturer Refuses EU Officials’ Inspection
  • USA – FDA awards another non-opioid pain drug breakthrough status
  • France – Philippe Tcheng élu Président du Leem
  • Europe – EC green-lights MSD’s Keytruda combo for lung cancer
  • Europe – Les mauvais brevets limitent l’accès aux médicaments en Europe
  • USA – AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status
  • USA – FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence
  • UK – The Family-run Fake Pill Factory: trio busted following drugs raid
  • Europe – Revised Guideline on requirements for revision/renewal of CEPs
  • Europe – Change in the classification of certain glucosamine products
  • USA – FDA on Pace for Record Generic Approvals in 2018
  • Europe – Janssen bags new EU approval for Darzalex
  • Europe – Sanofi’s Cablivi cleared for rare bleeding disorder
  • Europe – Chinese Pharmacopoeia in Strasbourg to illustrate new regulation for excipients
  • Europe – NICE says ‘no’ to Gilead’s Yescarta in draft guidelines
  • Europe – NICE u-turn recommends Ipsen’s Cabometyx for kidney cancer
  • Europe – New EU Task Force Unveils Two-Year Regulatory Roadmap to Mitigate Medicine Shortages
  • Europe – EU approves first CAR-T therapies
  • Asia – Six Asian Firms Blocked for Refusing FDA Inspections
  • USA – Roche, Novo Nordisk and Merck Weigh in on FDA Draft Guidance on Assessment of Pressor Effects
  • USA – Drug Prices in Ads: Senate Passes Amendment
  • USA – FDA Recommends Use of Placebo Only in Certain Oncology Trials
  • USA – Judge Denies J&J Motion to Dismiss Pfizer Lawsuit Over Remicade
  • Europe – Effective Protection Period for Medicines has Declined in Last Decade, EC Report Finds
  • USA – FDA Launches New Medication Guide Database
  • Europe – EC Drafts Guideline on GCP for Advanced Therapies
  • Europe – EMA Consults on Genetically Modified Cell Products Guideline
  • Category: International
    • International – Pfizer doses first patients with mRNA-based influenza vaccine
    • International – Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2)
    • International – ICH signs off on carcinogenicity testing addendum
    • International – Novartis confirms death of 2 children after gene therapy
    • International – ICH M10 on bioanalytical method validation
    • International – Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines
    • International – Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine
    • International – Moderna announces trial results for new COVID-19 booster vaccine candidate
    • International – ICH details milestones reached on guidelines after Athens meeting
    • International – FDA, EMA officials discuss impediments to cell and gene therapies
    • International – International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines
    • International – WHO recommends Veklury for high-risk patients
    • International – ICH plans model-informed drug development guideline in 3-4 years
    • International – Mechanical, material stresses affect drug quality
    • International – ICH releases draft guidelines on analytical method development
    • International – Excipient group releases guide on reporting microplastic use in pharmaceuticals
    • International – ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
    • International – ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs – questions and answers
    • International – Drop in data integrity violations linked to fewer inspections
    • International – Pfizer begins phase 2/3 study of oral COVID-19 treatment in paediatric patients
    • International – How will war in Ukraine affect global biopharma industry?
    • International – Report predicts a biosimilar « turning point » in 2022
    • International – Covid-19 : l’OMS recommande le traitement de Merck aux patients à risque
    • Interrnational – WHO issues prequalification for Roche’s Actemra/RoActemra for severe or critical COVID-19
    • International – ICH guide provides clarity on estimands, sensitivity analyses
    • International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
    • International – Pfizer and BioNTech start clinical trial for Omicron-based COVID-19 vaccine
    • International – Access Consortium Work-Sharing Initiative: An Industry Perspective
    • International – Covid-19: Un vaccin annuel préférable à des rappels fréquents selon Pfizer
    • International – WHO recommends baricitinib, sotrovimab to combat COVID-19
    • International – WHO charts path to convergence on cell and gene therapies
    • International – ICH releases revised Q9 guideline to improve risk assessments
    • International – Pharmaceutical groups want more clarity on continuous manufacturing guideline
    • International – ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
    • International – ICMRA: Remote inspections can complement, but not replace, onsite inspections
    • International – Pfizer/BioNTech promote booster against Omicron
    • International – ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
    • International – Booster plans expanded to combat Omicron
    • International – ICH recaps progress made over past year, charts new topics
    • Israel – Israel approves COVID-19 vaccines for children aged 5-11
    • International – Phagothérapie : un modèle animal pour étudier son potentiel antibactérien
    • International – COVID-19 vaccine tracker
    • International- Release of Draft (Step 2) ICH Guideline: Q13: Continuous Manufacturing of Drug Substances and Drug Products
    • International – ICH : 30th Anniversary Publication
    • International – ICH guideline E8 (R1) on general considerations for clinical studies
    • International – New WHO group could be ‘the last to find virus origins’
    • International – ICMRA: Industry’s commitment to quality can facilitate regulatory flexibility
    • International – Results of AstraZeneca’s TACKLE phase 3 trial show antibody combination reduces risk of severe COVID-19 or death
    • International – WHO has recommended GSK’s malaria vaccine for children
    • International – Covid-19 : que sait-on du nouveau médicament Molnupiravir ?
    • International – ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
    • International – ICH announces sign-off on good clinical practices guideline
    • International – WHO updates essential medicines lists
    • International – Janssen’s RSV vaccine provides high protection against respiratory infections
    • International – WHO seeks input on medicines to prioritize for BCS-based biowaivers
    • International – A new oral antiviral drug for COVID-19 is being tested in humans – can it make a difference?
    • International – UK vaccine swap with South Korea in joint effort against COVID-19
    • International – Positive topline results for Pfizer/BioNTech jab in five to 11-year-olds
    • International – ICH survey shows strong level of guideline implementation
    • International – FDA, EMA launch complex generic, hybrid product advice pilot
    • International – EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products
    • International – Convergence: Regulatory considerations in advancing gene and cellular therapies
    • International – Vaccin contre le Covid-19 : bientôt un spray nasal pour stopper le virus ?
    • International – Drugmakers should question suppliers’ nitrosamine tests
    • International – The most-used drugs for treating COVID-19
    • International – Interventions dans la prévention des troubles persistants de l’odorat (dysfonctionnement olfactif) suite à une infection par la COVID-19
    • Denmark – Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination
    • International – L’ICMRA cible les défis posés par l’IA dans le développement du médicament
    • International – BioNTech says booster doses may be more effective than a modified COVID-19 vaccine
    • International – WHO to test three more potential COVID-19 treatments
    • International – Researchers: France could teach the US lessons in biosimilar pricing
    • International – ICMRA releases framework for aligning global track and trace systems
    • International – WHO revises guidance on GMPs for investigational products, R&D facilities
    • International – Early data shows CanSinoBIO’s inhaled COVID-19 vaccine triggers immune response
    • International – Study shows AZ’s COVID-19 jab did not increase the rate of rare blood clots after second dose
    • International – ICH releases widely anticipated guidance on continuous manufacturing
    • International – Google’s DeepMind opens ‘breakthrough’ protein database to the world
    • International – BioNTech to use mRNA technology to develop a ‘highly effective’ malaria vaccine
    • International – Mixing AZ and Pfizer COVID-19 vaccines increases antibody levels
    • International – Global regulators promote platform trials to assess new COVID vaccines
    • International – PIC/S adopts guidance on PQS risk-based change management, COVID-19 risk assessments
    • International – AZ, J&J to research modifications to COVID-19 vaccines over rare blood clot issues
    • International – Upcoming ICH guidelines should ease post-approval changes for analytical methods
    • International – PIC/S finalizes GMP data integrity guidance
    • International – L’OMS publie son rapport mondial sur l’intelligence artificielle appliquée au domaine de la santé
    • International – ICH E17 Guideline on Multi-Regional Clinical Trials Catalyst for Simultaneous Global Development and Registration
    • International – Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)
    • International – PIC/S looks to adopt EU Annex on qualified persons, batch release
    • International – Let’s mix things up! Innovations in reconstitution technologies
    • International – ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards
    • International – International regulators and WHO address need to boost COVID-19 vaccine confidence
    • International – Les probiotiques dans la prévention du diabète sucré gestationnel
    • International – Vaccin anti-Covid GSK-Medicago : réponse immunitaire « Élevée » en Phase 2
    • International – Addendum to the Guideline on testing for Carcinogenicity of Pharmaceuticals S1B(R1)
    • International – FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers
    • International – Global regulators issue call for clinical trial data transparency
    • International – Moderna’s booster vaccines increase neutralising antibodies against COVID-19 variants
    • International – Moderna: COVID-19 vaccine offers 96% protection in teens
    • Russia – Russia’s Sputnik V COVID-19 vaccine developer launches single-dose version ‘Sputnik Light’ with 80% efficacy
    • International – ICH : Impurites : Guideline for Residual Solvents Q3C(R8)
    • International – ICH announces new data exchange with SNOMED to promote drug safety
    • International – PIC/S updates GMPs for ATMPs, biological substances
    • International – Pfizer CEO says oral COVID-19 pill could be ready by the end of the year
    • International – WHO to review Moderna’s COVID-19 vaccine for emergency use listing this week
    • International – Vaccin ASTRA-ZENECA : deux équipes concluent dans le NEJM à une même explication de l’origine des thromboses
    • International – ICH shares « work-in-progress » update to GCP guidance
    • International – ATMPs: Global regulators eye harmonization for ultra-orphan products
    • International – Pfizer est « en train de mettre au point deux médicaments contre le Covid »
    • International – Moderna’s COVID-19 vaccine can protect for 6 months
    • International – FDA, EMA team up on pediatric oncology drug development template
    • International – Le vaccin AstraZeneca change de nom
    • International – Sanofi and Translate Bio launch phase 1/2 trial of mRNA-based COVID-19 vaccine
    • International – Five things to know about the AstraZeneca/Oxford vaccine
    • International – Orphan product designation requests climb in the US, remain steady in the EU
    • International – New real-world evidence for Pfizer/BioNTech COVID-19 vaccine
    • International – Moderna launches COVID-19 vaccine booster study to address new variants
    • International – WHO/IAEA tackle investigational radiopharmaceutical GMP in draft guidance
    • International – Vaccine makers call for alternative study designs for COVID vaccines
    • International – Global medicinal supply chain examined in EC, US efforts
    • International – EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
    • International – Real-world data shows efficacy of Pfizer/BioNTech vaccine
    • International – Pfizer-BioNTech testing booster of their COVID-19 vaccine in new trial
    • International – England and Canada diverge from US on cancer drug decisions
    • International – AI promises to boost drug discovery success rate
    • International – Roche’s anti-inflammatory drug reduces deaths in hospitalised COVID-19 patients
    • International – WHO panel recommends AZ/Oxford’s COVID-19 vaccine
    • International – Vaccins anti-Covid 19 à ADN et à ARN : nouvelles technologies, nouveaux risques ?
    • Europe – International regulators working together to enhance collaboration on COVID-19 observational research
    • South Africa – South Africa puts AZ/Oxford COVID-19 vaccine roll-out on hold
    • Russia – Trial results: Russia’s COVID-19 vaccine 92% effective
    • International – Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released
    • International – Pfizer/BioNTech to develop a booster dose for their COVID-19 vaccine
    • International – Pfizer and Moderna haven’t proven their COVID-19 vaccines shield against new variants: analysts
    • International – Two Chinese coronavirus vaccines under review at WHO
    • International – WHO updates COVID vaccine and clinical care guidelines
    • International – WHO endorses schedule for 2-dose Pfizer vaccine
    • WEBINAR – VACCINS ANTI-COVID De quoi parle-t-on ?
    • International – WHO: Country regulators to review vaccine adverse effects
    • Russia – RDIF confirms Sputnik V COVID vaccine’s efficacy
    • International – Roche links with Moderna to include antibody test in COVID-19 vaccine trial
    • International – The Lancet publie les premiers résultats relatifs au vaccin anti-COVID-19 du Laboratoire ASTRA ZENECA
    • International – COVID-19 vaccine tracker
    • International – ICMRA: Continue COVID vaccine trials « as long as is feasible »
    • International – Derrière l’expression « Big Pharma », des milliards de dollars mais une réalité plus complexe
    • International – WHO proposes update of GMPs for investigational products
    • International – Le plasma provenant de personnes ayant guéri de la COVID-19 est-il un traitement efficace pour les personnes atteintes de la COVID-19 ?
    • International – Efficacité du vaccin Pfizer : des questions en suspens
    • Israel – Israel to launch human trials for COVID-19 vaccine
    • International – La difficile collaboration entre pharma, biotechs et entreprises du numérique
    • International – WHO : Solidarity Therapeutics Trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19 in record time
    • International – Medical cannabis regulation is a global patchwork
    • International – Des chercheurs chinois confirment l’efficacité d’un médicament russe contre le coronavirus
    • International – Trials and Hopes: Way ahead for Covid-19 treatment
    • International – Global clinical trials, clinical trial applications
    • International – COVID-19 : Vaccine approval won’t likely happen before Nov.
    • International – Cell and gene therapy : Regulatory Focus, July issue
    • International – Advanced therapies: ‘Trip hazards’ on the development pathway
    • International – Global regulators agree on endpoints for COVID-19 therapeutics
    • International – Coronavirus : la pandémie dope le trafic de produits pharmaceutiques
    • Russia – AstraZeneca confirms Russia vaccine deal days after COVID-19 hacking accusations surface
    • International – Managing uncertainty: Regulatory reporting in multinational trials during COVID-19
    • International – The top 15 pharma companies by 2026 sales
    • International – Six Guiding Principles for Pharmaceutical Companies to Achieve Global Quality
    • International – Good Regulatory Practices: ANVISA’s Regulatory Model for Brazil
    • International – Nations raise concerns about access to remdesivir
    • International – Biogen, Harvard partner on gene therapy for eye diseases
    • International – WHO takes stock of global COVID-19 R&D progress
    • International – Ethnic Differences, Regulatory Policies, and COVID-19
    • International – Global Electronic Labeling Initiatives: Updates from Japan, Canada, Europe, US, and Asia
    • International – Improving Access to CAR T Therapy: It’s Not Just Payment
    • International – EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
    • International – WHO ACT-Accelerator prioritizes global vaccine approach
    • International – Covid : l’OMS appelle à augmenter la production mondiale de dexaméthasone
    • International – European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
    • International – WHO warns against indiscriminate use of dexamethasone
    • International- Regulators discuss accelerated approvals, Project Orbis at DIA
    • International – How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis
    • International – WHO drafts recommendations for regulatory reliance
    • International – Rituximab biosimilar prequalified by WHO
    • International – ICH updates on upcoming guidelines, adds new participants
    • International – FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19
    • International – WHO reviewing hydroxychloroquine safety data
    • International – Un infectiologue marocain conteste l’étude de The Lancet sur la chloroquine
    • International – Medical Writing: The Language and Art of Scientific Communication
    • International – INSTITUT PASTEUR : Comment l’étude des mécanismes de multiplication du SARS-COV-2 permet d’identifier des molécules potentiellement antivirales
    • International – Using risk management to support outsourcing activities
    • International – WHO issues guidance for prequalified products amid COVID-19
    • International – Guidelines for successful influencer marketing
    • International – Impurities : Guideline for Residual Solvents Q3C(R8)
    • International – FDA, EU authorities update guidance on clinical trials during COVID-19
    • International – Et si la nicotine protégeait du Covid-19?
    • Russia – La Russie annonce avoir développé un médicament contre le Coronavirus
    • International – ICH adopts S11 guideline on nonclinical safety testing for pediatric drugs
    • International – ICH: MedDRA existing and supplemental codes for Coronavirus
    • International – Clinical Trials During COVID-19: Updates From FDA, MHRA and TGA
    • International – Predicting the angiotensin converting enzyme 2 (ACE 2) utilizing capability as the receptor of SRAS-CoV-2
    • International – Coronavirus : l’OMS réfute l’utilisation de médicaments sans preuve d’efficacité
    • International – COVID-19: Daily Report for Life Sciences and Health Care Companies
    • International – ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies
    • International – COVID-19 Vaccine Tracker
    • International – ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
    • International – Orphan drugs face “uphill battle” in 2020
    • International – Les Organoïdes supplantent désormais les méthodes In Silico dans la R&D
    • International – WHO drafts guidance for pharma supply chain tracking
    • International – ICH Plots Closer Collaboration With PIC/S
    • International – WHO publishes its draft Policy brief on traceability of health products for comments
    • International – Résistance aux antibiotiques : pour l’OMS, il est urgent de trouver de nouveaux médicaments
    • International – Swiss and Korean Regulators Agree to Mutually Recognize GMP Inspections
    • International – Improving Biosecurity with first International Standard for Biorisk Management
    • International – EU-China Working Group to Address API Manufacturing Concerns
    • International – Drugmakers working on powerful, targeted cancer treatments
    • International – ASEAN Adds Philippine FDA to GMP Mutual Recognition Program
    • International – WHO prequalifies first biosimilar medicine to increase worldwide access to life-saving breast cancer treatment
    • International – 4 Trends and Expectations for Drug Delivery in 2020
    • The Transformation of Digital Health: What it Means for Regulatory Professionals
    • International – PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change Management
    • International – Information Note Nitrosamine impurities
    • International – ICH Updates After Singapore Assembly Meeting
    • International – WHO Drafts Guideline on Data Integrity for Pharmaceuticals
    • International – FDA’s Project Orbis May Expand to Singapore and Switzerland
    • International – WHO Seeks to Expand Access to Insulin With Prequalification Program
    • International – ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry
    • International – ICH Updates: What to Expect Through 2020
    • International – Evolving Global Regulatory Landscape, Strategies and Best Practices
    • International – PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances
    • International – FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs
    • International – Médicaments : quelle(s) réalité(s) ?
    • International – Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas
    • International – WHO Revises Guidance on QMS Requirements for National Inspectorates
    • International – Top 9 Companies in the Diagnostics Market
    • International – Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States
    • International – WHO’s five-year plan to help build effective and efficient regulatory systems
    • International – WHO Updates Lists of Essential Medicines, Diagnostics
    • Europe – The impact of Mutual Recognition Agreement between the European Union and the United States as of 27 June 2019 : Questions & Answers
    • International – WHO develops classification system for protecting efficacy of antibiotics
    • International – ICH Adds Four New Regulatory Observers
    • International – ICH guideline E8 (R1) on general considerations for clinical studies : Step 2b
    • International – WHO Outlines Process to Designate Regulators as WHO-Listed Authorities
    • International – L’OMS adopte une résolution sur la transparence du marché des médicaments
    • International – Study quantifies drug revenue invested in R&D
    • International – WHO Stresses Role of GMP in Combatting Antimicrobial Resistance
    • International – Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations
    • International – ICH Drafts Revised Guideline on General Considerations for Clinical Studies
    • International – WHO Seeks Consultant to Help Cambodia Strengthen Drug Regulation
    • International – ICH Updates: What’s Coming in 2019 and Beyond
    • International – Guideline : General Principles for Planning and Design of Multi-Regional Clinical Trials E17
    • International – EU files WTO dispute with Turkey over pharma laws
    • International – Big Pharma come together for better drug side effect detection
    • International – ICH guideline E19 on optimisation of safety data collection
    • International – Guideline for Elemental Impurities Q3D(R1)
    • International – WHO Consults on QMS Guideline for Regulators
    • International – WHO Warns of Falsified Leukemia Drug in Supply Chain
    • International – NICE and Canadian counterpart to offer joint advice service
    • International – ICH Offers Updates on Guidelines, Working Groups
    • International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments
    • India – India’s CDSCO Seeks Feedback From Users of Online Drug, Medical Device Portals
    • International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States
    • International – EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections
    • International – Australia and Canada Extend Mutual Recognition Agreement to APIs
    • International – GSK’s says depot HIV injection works over three years
    • International – Valsartan prices double after recall
    • India – India Hews Closely to WHO GMP Guidelines in Planned Changes to Schedule M
    • International – Innovative Designs in Early Phase Oncology Studies
    • International – Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal
    • International – WHO Opens Consultation on New Biosimilar Q&A
  • Category: France
    • France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de vaccination pour l’automne
    • France – ANSM : Pholcodine : Suspension des autorisations de mise sur le marché et retrait de toutes les boîtes de sirop contenant de la pholcodine en raison d’un risque d’allergie croisée avec les curares
    • France – HAS : Covid-19 – un avis global sur les vaccins bivalents mi-septembre
    • France – La HAS recommande la vaccination des nourrissons contre les infections à rotavirus
    • France – Covid-19 : la HAS précise le cadre d’utilisation de Xevudy®
    • France – Expérimentation du cannabis médical : évolution des critères d’inclusion dans l’indication oncologie
    • France – Coqueluche : vacciner la femme enceinte pour protéger le nouveau-né
    • France – Paracétamol : des médecins découvrent un effet indésirable préoccupant
    • France – Covid-19 : levée de la contre-indication à la primovaccination après un PIMS
    • E-santé : la HAS publie 4 référentiels de télésurveillance médicale
    • France – Les vaccins à ARNm contre la Covid-19 n’augmentent pas le risque d’infarctus du myocarde, d’accident vasculaire cérébral ou d’embolie pulmonaire chez les adultes de moins de 75 ans
    • France – ANSM : Periactine 4 mg (cyproheptadine) : risques liés à l’utilisation non conforme comme orexigène à des fins esthétiques
    • France – Sérialisation: « environ 5.000 officines » connectées au répertoire national de vérification des médicaments (France MVO)
    • France – Covid-19 : deux nouvelles alternatives aux vaccins à ARNm
    • France – Décision n° 2021.0313/DC/SEM du 9 décembre 2021 du collège de la Haute Autorité de santé portant refus de la demande d’accès précoce de la spécialité LAGEVRIO (molnupiravir)
    • France – Dématérialisation des essais cliniques: vers une pérennisation de la pratique?
    • France – Cannabis médical : un écran de fumée ?
    • France – Livmed’s: la plateforme de livraison de médicaments boucle sa première levée de fonds
    • France – L’accès précoce confronté aux difficultés du recueil de données en vie réelle
    • France – Covid-19 : la HAS préconise une dose de rappel pour les personnes de 40 ans et plus
    • France – HAS : Cancer du sein triple négatif : la HAS autorise le Keytruda en accès précoce
    • France – E-Parcours: 257 projets financés pour 142 millions d’euros engagés au total (ministère)
    • France – Dose de rappel anti-COVID-19 : n’utiliser que le vaccin de Pfizer, recommande la HAS
    • France – Les pharmaciens officinaux autorisés à reconstituer les vaccins à ARN messager, et à les distribuer
    • France – La vaccination est efficace à plus de 90% pour réduire les formes graves de Covid-19 chez les personnes de plus de 50 ans en France
    • France – Covid-19 : utiliser le vaccin de Pfizer pour le rappel de vaccination
    • France – Oncologie: Pierre Fabre lance une plateforme pour accompagner les pharmaciens d’officine
    • France – Antibiothérapie : La HAS revoit sa copie
    • France – Cancer du sein triple négatif : la HAS autorise le Trodelvy en accès précoce
    • France – Synapse Medicine décroche la certification « logiciel d’aide à la prescription »
    • France – Études en vie réelle pour l’évaluation des médicaments et dispositifs médicaux
    • France – L’ATIH lance une nouvelle application pour étudier la consommation de médicaments et DM
    • France – MaPUI Labs lance une plateforme numérique qui centralise les tensions et ruptures de stock de médicaments
    • France – Médicament: la collecte de données de vie réelle renforcée par la réforme de l’accès précoce
    • France – Cercles de qualité médecins-pharmaciens : une initiative bienvenue
    • France – Décision n° 2021.0187/DC/MNS du 8 juillet 2021 du collège de la Haute Autorité de santé portant actualisation de la procédure de référencement des systèmes d’aide à la décision indexée par médicament (SAM) à intégrer dans les logiciels d’aide à la prescription et dans les logiciels d’aide à la dispensation
    • France – Vaccination contre la Covid-19 : pas de dose de rappel pour le moment en dehors des plus vulnérables et des plus âgés
    • France – HAS – Publication du guide intitulé « Autorisation d’accès précoce aux médicaments : doctrine d’évaluation de la HAS »
    • France – Décision n° 2021.0157/DC/SEVOQSS du 10 juin 2021 du collège de la Haute Autorité de santé portant adoption du document Flash sécurité patient « Médicaments à risque « Sous-estimer le risque c’est risqué »
    • France – Rapport d’activité 2020 de la HAS
    • International – Study finds mixed vaccine schedules provide strong immune response against COVID-19
    • France – Méningocoques B : la HAS recommande la vaccination des nourrissons
    • France – Quatre nouveaux cas de thromboses en France avec AstraZeneca, dont deux décès
    • France – Covid-19 : la biotech nantaise Xenothera annonce une précommande de la France pour son traitement
    • France – Covid-19: la Cnil publie des recommandations « temporaires » pour le contrôle qualité des essais cliniques
    • France – Comment la direction « innovation, data et digital » de Novartis France fait sa mue
    • France – Cyberattaque: Pierre Fabre annonce un « retour progressif à la normale » de ses activités
    • France – Stratégie de vaccination contre le Sars-Cov-2 – Recommandation relative à la vaccination contre la COVID 19 de l’entourage de certaines populations vulnérables – synthèse des données relatives à l’efficacité des vaccins contre la COVID-19 sur la transmission du SARS-COV-2 au 1er avril 2021
    • France – Accélérer l’évaluation des perturbateurs endocriniens
    • France – L’ANS veut guider les entrepreneurs du numérique en santé vers l’industrie du médicament
    • France – Nanomédicaments : Les acides nucléiques thérapeutiques, du cancer à la Covid-19
    • France – Docaposte remporte à nouveau le marché d’hébergement du dossier pharmaceutique
    • France – Anticorps monoclonaux : l’ANSM permet l’utilisation en accès précoce de deux bithérapies contre la COVID-19
    • France – Signature d’un nouvel accord-cadre entre le Comité économique des produits de santé (CEPS) et le Les Entreprises du médicament (LEEM)
    • France – Comment relancer l’innovation Pharmaceutique en France ? par Frédéric BIZARD, Economiste
    • France – Novartis says it’s ready to pitch in on manufacturing rivals’ COVID-19 vaccines, diagnostics
    • France – Les erreurs associées aux produits de santé déclarées dans la base EIGS
    • France – L’ANSM publie la liste des fournisseurs retenus pour l’expérimentation de l’usage médical du cannabis en France
    • France – Joël Ankri est nommé président du Conseil scientifique de l’ANSM
    • France – ANSM : Premier point de situation sur la surveillance des vaccins contre la COVID-19
    • France – Cartographie des impacts organisationnels pour l’évaluation des technologies de santé
    • 2021 ! Année de l’espérance
    • France – Documents de l’Agence nationale de sécurité du médicament (ANSM) sur la pharmacovigilance
    • France – Le parcours de Christelle Ratignier-Carbonneil, nouvelle directrice générale de l’ANSM
    • France – Antibiorésistance : face à un fléau mondial, une toute première interface nationale
    • France – ANSM : Christelle Ratignier-Carbonneil à la tête de l’Agence du médicament
    • France – Le label « priorité nationale de recherche »
    • France – Stratégie de vaccination contre le Sars-Cov-2 – Recommandations préliminaires sur la stratégie de priorisation des populations à vacciner
    • France – HAS : Aspects immunologiques et virologiques de l’infection par le SARS-CoV-2
    • France – La liste noire des 93 médicaments à éviter en 2021
    • France – Covid-19. Pfizer, Moderna, Sanofi : six questions pour s’y retrouver parmi ces vaccins prometteurs
    • France – ANSM : Rapport d’activité 2019
    • International – Vaccins contre la COVID-19 : un point sur les essais de phase III en cours
    • France – Covid-19 : L’Institut Pasteur développe un vaccin issu de celui de la rougeole
    • France – Premiers résultats encourageants pour la plateforme eNephro de télésuivi des malades rénaux chroniques
    • France – HAS : COVID-19 – VEKLURY : Demande de remboursement retirée par le laboratoire après avis favorable au remboursement
    • France – L’ANSM publie sa décision sur la demande d’une RTU pour l’hydroxychloroquine dans la prise en charge de la maladie Covid-19
    • France – Servier se dote d’une direction « Digital, data et systèmes d’information »
    • France – L’expérimentation de l’usage médical du cannabis : Décret n° 2020-1230 du 7 octobre 2020
    • France – Loi anti-cadeaux : nouvelles dispositions présentées par Simmons & Simmons
    • France – ANSM : Lutényl/Lutéran et risque de méningiome
    • France – L’Union européenne signe avec Sanofi-GSK un contrat de précommande de vaccins contre la Covid-19
    • France – Mise en garde sur l’utilisation potentiellement dangereuse de médicaments chez des enfants atteints d’autisme
    • France – Un Guichet unique pour accompagner l’innovation
    • France – Prolongation des certifications délivrées par la HAS aux logiciels d’aide à la prescription
    • France – Le nouveau dispositif « anti-cadeaux », évolutions légales et nouvelles contraintes pratiques – WEBINAR Vendredi 18 septembre de 09h30 à 11h00
    • France – Le nouveau décret relatif à la prise en charge des produits de santé souffle le chaud et le froid sur l’accès au marché
    • France – Choix méthodologiques pour l’évaluation économique à la HAS
    • France – COVID-19 : octroi d’une ATU de cohorte pour le médicament remdesivir, afin que les patients puissent continuer à en bénéficier en France – Point d’information
    • France – La relocalisation de la production de médicaments en cinq questions
    • France – ANSM et COVID-19 – Demandes de visas publicitaires de médicaments
    • France – Venant juste d’être octroyée en France, l’AMM de Baclocur® (baclofène) est suspendue par le justice !
    • France – France Biotech annonce la création d’un nouveau groupe de travail dédié au « Market Access » des sociétés innovantes en santé
    • France – HAS : KEYTRUDA – Cancer bronchique non à petites cellules 1ere ligne
    • France – COVID-19 et médicaments importés : attention au risque d’erreurs médicamenteuses
    • France – Médicament en tension ou rupture de stock
    • France – Le microbiote intestinal, une source de traitements contre le diabète
    • France – Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance
    • France – Prorogation de l’accord-cadre entre le Leem et le Comité économique des produits de santé
    • France – L’Assemblée Nationale adopte un amendement historique sur la transparence
    • USA – Evaluating the Potential of Microengineered Human Cellular Systems to Predict Drug Effects in the Clinic
    • France – ATU – Autorisations temporaires d’utilisation
    • France – Médicaments : les laboratoires bientôt sanctionnés en cas de pénurie
    • France – Mediator Ouverture d’un Procès Hors Norme
    • France – Une association de patients s’insurge contre l’embauche d’un ancien et récent haut responsable de la HAS par une société de conseils auprès de l’industrie pharmaceutique
    • France – Androcur et ses génériques (Acétate de cyprotérone) et risque de méningiome : publication du rapport complet de l’étude de pharmaco-épidémiologie
    • France – ANSM : Paracétamol – Surdosage = Danger !
    • France – Parution du nouveau Guide Pharma
    • France – HAS : « Choix méthodologiques pour l’évaluation de l’efficience à la HAS – Guide méthodologique
    • France – Androcur et ses génériques (Acétate de cyprotérone) et risque de méningiome : Résultats de l’enquête de pharmacovigilance
    • Tout ce qu’il faut savoir sur les Biosimilaires – Interview du Pr Jean-Hugues Trouvin par Yves Tillet
    • France – La transplantation de microbiote fécal
    • France – Levothyrox et médicaments à base de lévothyroxine : Rapport final
    • France – Point de situation sur la disponibilité des corticoïdes en France – Point d’Information
    • France – La prophylaxie pré-exposition (PrEP) au VIH par ténofovir disoproxil/emtricitabine (TRUVADA® et ses génériques)
    • France – Seule une refondation de la politique du médicament permettra de retrouver une industrie pharmaceutique compétitive
    • France – ANSM : Cannabis à visée thérapeutique en France : Les experts poursuivent leurs travaux sur les modalités de mise à disposition
    • France – Le GEMME se félicite de l’adoption d’une mesure en faveur de l’industrie européenne de fabrication des médicaments génériques et biosimilaires
    • France – Signature de l’avenant à l’Accord-cadre « nouvelle procédure de négociations des prix au CEPS »
    • France – ANSM : Venclyxto (vénétoclax) : signal de sécurité issu de l’essai clinique évaluant le vénétoclax dans le traitement du myélome multiple – Point d’Information
    • France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves – Point d’Information
    • France – Maladies rares : l’Inserm coordonne un programme européen d’ampleur inégalée
    • France – Clinical trials on medicinal products submitted to the ANSM as part of the FastTrack procedure
    • France – REVUE PRESCRIRE : LA LISTE NOIRE DES 68 MÉDICAMENTS DANGEREUX
    • France – L’année 2019, une année cruciale pour la loi « anti-cadeaux » !
    • France – Le CNOP dévoile trois rapports sur la prévention, les nouvelles technologies et la pharmacie clinique
    • France – Nouveau rappel de médicaments à base de valsartan
    • France – Hépatite C. Le laboratoire Gilead baisse le prix de ses coûteux traitements de 20 %
    • France – Renouvellement de la commission de la transparence de la HAS
    • France – Plateforme de signalement des effets indésirables : un premier bilan
    • France – L’agence du médicament lance un dispositif accéléré d’autorisation d’essais cliniques
    • France – Zelboraf/Cotellic : Rappel du risque d’atteintes opthalmiques et de leur prise en charge
  • Category: Europe
    • Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2)
    • Europe – EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
    • Europe – EDQM and EC build on 10 years of co-operation to support a more sustainable blood supply and resilient blood sector
  • Category: Amériques
    • Canada – La pilule anti-COVID de Pfizer approuvée par Santé Canada
    • USA – FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe
  • Category: Asie-Pacifique
  • Category: Découverte
    • USA – 10-year study shows CAR T-cell therapy cured cancer in 2 patients
• Category: DM-DIV
  • Spain – Des applis mobiles pour prédire le risque d’exacerbations de BPCO et détecter le Covid-19 grâce à la voix
  • France – Comment la médecine in silico peut accélérer l’innovation en matière de DM
  • Europe – MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
  • Brazil – ANVISA announces major medical device registration updates
  • USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
  • USA – FDA drafts guidance on device production and quality system software assurance
  • Europe – New European Manual on Borderline and Classification for medical devices and IVDs issued
  • USA – Patient preference information: Researchers offer insights on medical device clinical trial design
  • Australia – Update: Medical device UDI implementation, Essential Principles guidance
  • UK – Medical devices: UK approved bodies
  • Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs
  • Europe – New study shows pioneering test for endometrial cancer could significantly reduce diagnosis time
  • South Korea – Updates: Innovative device designations, IVD Act enforcement
  • India – Indian regulators add to list of medical device testing laboratories
  • Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) (deuxième avis)
  • Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) (première avis)
  • USA – FDA finalizes rule for over-the-counter hearing aid devices
  • China – Update: Class I medical device filing rules, UDI standards
  • USA – FDA: Nearly 700 breakthrough medical device designations since 2015
  • Europe – New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR
  • South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
  • China – Chinese regulators recommend clinical evaluation paths for certain medical devices
  • USA – FDA eases UDI compliance requirements for some low-risk medical devices
  • South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
  • Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR
  • Japan – Japan updates guidance on QMS Conformity Survey applications
  • Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)
  • Singapore – Singapore adds HIBCC to list of UDI issuing agents
  • Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey
  • India – India issues new draft IVD rules and updated classifications for rehab devices
  • Australia – Australia updates guidance on implantable medical devices, required six-monthly report
  • UK – E-cigarettes: regulations for consumer products
  • China – NMPA rules on medical device naming, QMS inspections and industry standards
  • Italy – The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
  • Europe – Commission publishes implementing regulation on specifications for class D diagnostics
  • Europe – Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
  • UK – What will the UK MHRA consultation bring in terms of medical device and IVD regulations?
  • Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private health insurance rules for prostheses
  • UK – UK to strengthen regulation of medical devices to protect patients
  • USA – FDA finalizes guidance on machine learning for medical devices
  • France – Une appli mobile pour accompagner les soignants dans la prise en charge des plaies chroniques et/ou complexes
  • Europe – CAMD Statement – 50th CAMD Plenary meeting
  • South Korea – South Korea updates regulations on medical device codes and classification
  • USA – FDA takes a step forward for machine learning with quantitative imaging guidance
  • Japan – Japan’s medical device regulators update PMD Act and the online submissions process
  • UK – MHRA joins international partnerships to set global standards for medicines and medical devices regulation
  • USA – La FDA planche sur des directives relatives à la sécurité des objets connectés de santé
  • China – Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific guidelines and technical review points
  • Europe – MDCG 2022-11 MDCG Position Paper Notice to manufacturers to ensure timely compliance with MDR requirements
  • USA – US FDA withdraws COVID-era guidance for medical device and IVD market approval processes
  • Europe – EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation
  • Europe – Exercer la fonction de PCVRR : où en sommes-nous aujourd’hui ?
  • USA – FDA considers pilot for lower radiation levels for device sterilization
  • Europe – New Swiss IVD regulations come into force as EU mutual recognition agreement expires
  • Australia – Process chart: Australia TGA regulatory approval for medical devices
  • India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses
  • Europe – Artificial intelligence in healthcare
  • USA – FDA adds transition period to electromagnetic compatibility final guidance
  • USA – Pre-submission requests for IVDs to be accepted by FDA
  • Europe – MDR/IVDR: Commission seeks comment on revisions to standardization request
  • Switzerland – Switzerland joins EU in bringing in new IVD requirements to improve patient safety
  • Europe – New guidance from European MDCG ahead of date of application
  • Europe – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials
  • Australia – Update: TGA defines which digital mental health software it regulates
  • Europe – IVDR implementation day overshadowed by lack of notified bodies, risks to patients
  • Europe – SSCP expert lists common mistakes device manufacturers make
  • Europe – MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
  • Brazil – ANVISA extends Brazilian Good Manufacturing Practice requirements to more medical device manufacturers
  • Europe – MDCG 2022-9 Summary of safety and performance Template
  • Europe – MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
  • Europe – Uniformiser le processus d’enregistrement des DM à l’échelle de la planète
  • Europe – IVDR Watch: European regulators add ISO 14971 to harmonized standards list
  • Europe – TUV NORD Polska New Notified Body Designated Under MDR
  • Europe – UDEM Adriatic d.o.o. New Notified Body Designated Under MDR
  • Europe – MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • UK – What do companies supplying IVDs to the UK market need to know about the IVDR?
  • USA – FDA asks manufacturers to develop risk management plans to avert shortages
  • Brazil – Brazil’s ANVISA repeals medical device regulations related to the coronavirus pandemic
  • Europe – Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
  • USA – FDA moves forward with Voluntary Improvement Program to bolster medical device quality
  • UK – Medical devices: UK approved bodies
  • Singapore – Singapore issues new guidance for software as a medical device
  • USA – Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device
  • Europe – Machine Learning-enabled Medical Devices: Key Terms and Definitions
  • Europe – IMDRF: Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form
  • Europe – Compliance for medical device makers in the EU and Turkey just got easier
  • India – India’s DCGI adds more medical device testing laboratories
  • Europe – MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
  • USA – FDA drafts guidance on medical device voluntary improvement program
  • USA – First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing
  • Europe – 3EC International becomes seventh Notified Body designated under EU IVDR
  • Europe – Implementing the Medical Devices Regulation (MDR)
  • Australia – TGA publishes latest medical device application processing times
  • Europe – IVDR Watch: European regulators update SSCP rules, high-priority implementation actions and technical documentation guidelines
  • USA – FDA warns that some prenatal screening tests can generate false results
  • Europe – UDI Devices – User guide
  • USA – FDA offers guidance on waiver requests for pH adjusters
  • USA – FDA recommends sponsors plan to include race, ethnicity in clinical trial design
  • Brazil – Brazilian regulators update Good Manufacturing Practices for medical devices and IVDs
  • Australia – TGA expectations for transition to 2021 Advertising Code and updated guidance on reclassification of AIMDs
  • USA – FDA finalizes two more safety and performance based pathway guidances
  • China – Medical Device Classification Catalogue, manufacture and distribution rule revisions
  • USA – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
  • USA – FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances
  • Europe – Update : Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
  • UK – NHS develops world-first bedside genetic test to prevent babies going deaf
  • Europe – MedTech Europe updates ethical code
  • USA – Commenters seek improvements in FDA’s computational modeling draft guidance
  • Australia – Australian reforms to Prostheses List may affect medical device reimbursements
  • Brazil – Brazil’s ANVISA issues registration rules for software as a medical device (SaMD)
  • USA – RF Quarterly, April 2022: Software as a medical device
  • USA – Clinical evaluation of software
  • UK – NICE recommends flash devices to type 1 diabetes patients
  • USA – MDUFA V: US FDA sets performance goals for De Novo medical device reviews
  • USA – Strengthening supply chains to mitigate medical device shortages
  • USA – Stakeholders ask for more time to transition EUA devices, diagnostics
  • USA – Digital human factors engineering platform now available for medical device manufacturers
  • Asia – Asia-Pacific Roundup: India consults on voluntary medical device marketing code
  • France – Diabète: lancement de FreeStyle Libre 3, plus petit et connecté automatiquement au téléphone du patient
  • USA – Report: Using RWD to evaluate AI-enabled clinical decision support tools
  • USA – US FDA Cybersecurity Alert: Risks found in medical device software components
  • China – China regulatory roundup: Latest guidelines for medical device and IVD compliance
  • USA – FDA slams California company for selling brain devices without approval
  • Europe – European IVDR resource center: Prepare for compliance
  • USA – US FDA recommendations for voluntary recalls of medical devices and products
  • USA – Quality System Regulation Amendments – Frequently Asked Questions
  • Europe – Arrêté du 4 mars 2022 fixant la charte de qualité des pratiques professionnelles des personnes chargées de la présentation, de l’information ou de la promotion des dispositifs médicaux à usage individuel, des produits de santé autres que les médicaments et des prestations de service éventuellement associées
  • International – Researchers develop portable device to detect Parkinson’s
  • USA – FDA OKs drug-eluting contact lens from J&J Vision
  • USA – How long is the FDA review process for 510(k) medical device submissions?
  • USA – This Week at FDA: HHS delays SUNSET rule, FDA begins release of Comirnaty review docs, and more
  • USA – FDA calls on firms to be ‘recall ready’ in final guidance
  • USA – QMSR: Industry wants to avoid ISO 13845 ‘plus,’ seeks longer transition period
  • UK – UK approved bodies for medical devices
  • USA – Digital smoking treatment device gets breakthrough status
  • USA – FDA offers guidance on patient-focused product development
  • USA – Device companies urge FDA to refine guidance on PCLC devices
  • USA – QMSR: FDA previews questions ahead of device GMP adcomm
  • USA – US FDA formally proposes aligning Quality System Regulations with ISO 13485
  • Singapore – Singapore’s HSA issues new rules affecting COVID-19 tests
  • USA – FDA Roundup: February 22, 2022
  • USA – QSMR: FDA proposes QSR overhaul after years of delays
  • Canada – Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19
  • Europe – MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR
  • Europe – MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies
  • South Korea – South Korea plans partial amendments to rules on medical device manufacturing license renewals
  • India – India issues draft rules for medical device and IVD registration certificates
  • USA – 3D printing medical devices: Stakeholders weigh in on FDA’s discussion paper
  • Switzerland – Selon SWISS MEDTECH la Commission européenne viole le droit existant
  • USA – Device group urges FDA to refine software function guidance
  • Japan – New guidelines from Japanese regulators cover medical device cybersecurity, remanufactured devices and MDSAP reports
  • USA – US FDA roundup: Final rules for combination products, patient reports for medical device evaluation, patient input on clinical studies
  • Europe – IVDR watch: Updated Joint Implementation Plan targets risk of IVD shortages
  • USA – FDA OKs personal, Bluetooth-enabled ECG device
  • Malaysia – Malaysian regulators update MedC@st electronic medical device registration system
  • USA – US FDA rolls out notification requirements to protect medical device supply chains
  • USA – FDA: Device breakthrough program surpassed expectations, while novel device authorizations fell in 2021
  • International – Un ordinateur médical qui permet de protéger les nerfs
  • France – Vers un pansement libérant un agent antimicrobien si besoin
  • Europe – L’UE et la Suisse prennent des chemins différents sur la question des DM
  • France – Les dangers liés au MDR : la profession tire la sonnette d’alarme !
  • Europe – MDCG 2022-2 : Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
  • Europe – Règlement (UE) 2022/112 modifiant le règlement (UE) 2017/746
  • USA – FDA finalizes guidance on premarket review of combination products
  • Brazil – Brazilian regulators to allow sales of COVID-19 self-test kits to consumers
  • USA – COVID-19 pauses US FDA inspection plans, again
  • USA – Final FDA guidances focus on improving device trials
  • Europe – European Notified Bodies issue updates on MDR, IVDR implementation challenges
  • India – Indian regulators delay implementation of UDI for medical devices
  • Europe – MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
  • Europe – European Parliament endorses legislation bolstering EU’s ability to tackle shortages
  • USA – CDRH outlines plan to understand sex and gender differences in medical devices
  • USA – FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women
  • UK – Medical devices given exceptional use authorisations during the COVID-19 pandemic
  • USA – This Week at FDA: User fee update, Califf nomination…
  • Europe – Prothèses mammaires PIP : le certificateur TÜV Rheinland doit indemniser 1 600 nouvelles plaignantes
  • Europe – New Notified Body designated to IVD Directive in Europe
  • USA – US FDA lays out post-COVID EUA transition plans for medical devices
  • USA – Draft Guidance : Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  • Europe – IVDR: European Commission publishes second batch of harmonized standards
  • USA – FDA seeks comment on device shortage reporting guidance
  • USA – FDA issues draft guidance on assessing physiologic closed-loop control devices
  • Europe – European Commission publishes second batch of harmonized standards under MDR
  • USA – New blood test can identify presence of cancer
  • USA – Computational modeling and simulation: FDA outlines framework for assessing credibility
  • Switzerland – Medical device direct imports to users in Switzerland
  • UK – The past, the present, and the future of clinical trials transparency in the UK
  • USA – Covid-19 : les tests antigéniques seraient moins sensibles au variant Omicron
  • USA – New Sterilization Technology Offers an Alternative to EtO
  • Europe – EU IVDR Readiness Assessment Checklist
  • France – Inventer l’équivalent du pacemaker pour le cerveau
  • China – Première angioplastie coronaire avec l’assistance du robot R-One en Chine
  • Europe – Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation
  • UK – Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
  • Europe – EC outlines rules for electronic IFU for med devices
  • USA – Un algorithme associé aux montres connectées Fitbit apparaît fiable pour détecter la fibrillation atriale en population générale
  • USA – Discussion Paper: 3D Printing Medical Devices at the Point of Care
  • USA – Pharma, device groups oppose FDA’s planned drug to device transition
  • USA – Groups request clarifications to safety reporting draft guidance
  • UK – Marketing authorisation acquired for first and only transdermal contraceptive patch in UK
  • Europe – MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation
  • Japan – Japan PMDA updates MDSAP policies ahead of 2022 implementation deadlines
  • Canada – Canadian regulators issue new reporting requirements for medical device shortages
  • USA – FDA expands eSTAR filing to de novo devices, IVDs
  • UK – Le groupe LNE crée une filiale de GMED au Royaume-Uni
  • Europe – Intégrer design et aptitude à l’utilisation dans le développement d’un DM
  • Europe – Commission Européenne 25ème organisme notifié au Titre du Règlement (UE) 2017/745
  • Europe – EUDAMED : Règlement d’Exécution (UE) 2021/2078
  • Europe – Droit et éthique des DM à base d’IA : l’Europe et la France accélèrent !
  • Australia – Australian regulators plan up-classification of medical devices targeting circulatory, nervous systems
  • Australia – Australia Regulatory Roundup: medical device clinical evidence, reclassification, post-market monitoring
  • France – Le CHU de Clermont-Ferrand intègre le laboratoire de recherche SimatLab
  • USA – FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II
  • Europe – List of views provided and ongoing consultations under the PECP
  • USA – Industry, clinician groups have different wish lists for AI/ML-enabled device labels
  • China – IVD classification rules, medical device self-testing requirements
  • France – Forum sur l’évaluation de l’IA, le 24 novembre à Paris
  • Australia – Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin
  • Europe – Que disent les règlements européens sur les DM face aux défis de l’IA ?
  • Europe – Outil de filtrage pour le règlement européen sur les DMDIV
  • Australia – Software for use with COVID-19 rapid antigen self-tests
  • International – Robotic Surgery Ecosystem: The path to democratize surgery
  • Europe – Deal on stronger role for EU medicines regulator
  • India – Indian regulators propose easing ISO 13485-related requirements for medical device registrants
  • USA – FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
  • USA – FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
  • USA – CDRH outlines guidance plans for FY2022
  • International – Bandage can monitor chronic wounds
  • Europe – MDCG 2021-25 : Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
  • USA – Defining critical tasks for human factors validation tests of combination products
  • USA – FDA issues proposed OTC hearing aid rule
  • USA – FDA says IRB review still needed for IVD studies involving human specimens
  • UK – MHRA launches public consultation on future of medical device regulation
  • USA – FDA nixes GUDID submission requirements for class I consumer healthcare devices
  • Europe – IVDR: Commission proposes to delay implementation amid ‘grave’ notified body shortage
  • USA – Microspheres for knee osteoarthritis get breakthrough status
  • Europe – Eudamed update: Additional data entry modules now online for European medical device, IVD registrants
  • Japan – Japanese regulators extend Medical Device Single Audit Program (MDSAP) pilot
  • Australia – Classification of active medical devices (including software-based medical devices)
  • USA – FDA reclassifies surgical staplers, staples after review links devices to injuries and deaths
  • Europe – MDCG 2021-24 : Guidance on classification of medical devices
  • USA – FDA finalizes long delayed de novo classification rule
  • Australia – Australian regulators plans up-classification of medical devices targeting circulatory, nervous systems
  • USA – FDA drafts safety reporting guidance for drug and device investigators
  • UK – MHRA shares guidance on need to review registration of medical devices
  • USA – US FDA rolls out list of registered medical devices featuring artificial intelligence and machine learning
  • USA – FDA issues draft guidance on electronic 510(k) submissions
  • International – Asia-Pacific Roundup: TGA posts guidance on reclassification of certain implantable devices
  • USA – FDA publishes first batch of device material safety reports in ECRI partnership
  • USA – FDA Authorizes Software that Can Help Identify Prostate Cancer
  • USA – FDA OKs new pathology AI software, launches AI-enabled device database
  • Australia – Reclassification of spinal implantable medical devices
  • Australia – Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems
  • France – La FDA se réorganise et crée un  »bureau de la transformation numérique »
  • India – Indian regulators publish new classification lists for medical device registrants
  • Australia – Australia TGA to accept CE Mark conformity assessments for some high-risk medical devices, IVDs
  • Australia – Software for use with COVID-19 rapid antigen self-tests
  • UK – Transforming the regulation of software and artificial intelligence as a medical device
  • UK – MHRA launches public consultation on future of medical device regulation
  • Australia – Conformity assessment certificates, changes to requirements for certain medical devices
  • Japan – Convergence: First-year experience with Japan’s amended medical device rules
  • Singapore – Singapore HSA recommends cybersecurity protections against BrakTooth for Bluetooth medical devices
  • Europe – Le TUV Rheinland Italia SRL, 23ème ON habilité au titre du RDM
  • USA – FDA outlines safety and performance-based criteria for facet screw systems and denture base resins
  • Singapore – Singapore HSA finalizes Unique Device Identification (UDI) requirements for medical devices
  • USA – Vagal nerve stimulator for stroke rehab nabs FDA nod
  • UK – Register medical devices to place on the market
  • Europe – Proposal for an Artificial Intelligence Act (COM/2021/206) – MedTech Europe response to the open public consultation
  • China – Chinese regulators revise drug-device combination product registration requirements
  • Europe – MDCG 2021- 23 : Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • USA – FDA updates safety communication for robotically assisted surgical devices used in mastectomy
  • Europe – MDCG 2021-22 : Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
  • USA – FDA affirms increased risk with pelvic mesh products
  • USA – Update: Check first with FDA regarding their current availability to review a human factors validation test protocol
  • USA – Update: FDA is not accepting human factors validation test protocols for review until further notice
  • South Korea – South Korea MFDS plans several medical device regulatory updates for 2022
  • USA – Proposed US FDA program targets medical device supply chain shortages
  • Europe – Notified bodies report success — and some drawbacks — using remote audits
  • Brazil – Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers
  • UK – Post-Brexit medical device and IVD oversight: A new plan for the UK MHRA
  • Europe – CARMAT : annonce la première implantation humaine de son cœur artificiel Aeson® en Allemagne
  • Australia – Is my software regulated?
  • Australia – TGA international engagement strategy 2021-2025
  • Taiwan – Final exemption list, cybersecurity guidelines, COVID-19 measures and more (Update)
  • Europe – “UE for PDC”: Little bits of usability engineering for platform-device companies
  • USA – CDRH official offers advice for smoother Q-submission meetings
  • USA – FDA seeks expanded authority to boost device supply chain
  • Europe – Team-NB Position Paper on “implant card”
  • Europe – MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations
  • Europe – 22ème ON vient d’être notifié au titre du règlement UE 2017/745. Il s’agit d’Eurofins Italy
  • Europe – New guidelines published on integrating UDI into quality management systems under MDR, IVDR in Europe
  • Singapore – Singapore HSA holds consultation on SaMD classification draft guidance
  • China – China NMPA seeks feedback on optimization of medical device standards
  • Asia – Asia-Pacific Roundup
  • Europe – RDM : que faut-il retenir pour l’UE et quels impacts hors Europe ?
  • France – Simulations biomécaniques : l’avenir de l’ingénierie médicale
  • Australia – Consultation: Proposed refinements to the regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin
  • Europe – MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system
  • Europe – KIWA (Italy) – 21ème ON au titre du RDM
  • Asia – Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies
  • Europe – MDCG 2021-14 Explanatory note on IVDR codes
  • Europe – Euro Roundup
  • USA – FDA finalizes long-awaited UDI guidance
  • USA – US FDA revokes Emergency Use Authorizations (EUA) for some personal protective equipment (PPE)
  • Europe – Loi Jardé et Règlement (UE) 2017/745 : le point sur la matériovigilance
  • Europe – Le premier avis des groupes experts scientifiques dans les domaines des DM est publié :
  • UK – Freedom of Information responses from the MHRA – week commencing 3 May 2021
  • Europe – ANSM – Dispositions nationales relatives à l’enregistrement des DM dans l’attente de la mise à disposition d’EUDAMED
  • USA – FDA report examines use of patient experience data in decision-making
  • USA – US FDA aims to improve cybersecurity related to servicing and maintenance of medical devices
  • Singapore – Singapore HSA explains new developments for COVID-19 test kit authorizations
  • Europe – Conseil et Parlement Européen : projet de renforcement du rôle de l’EMA relatif aux médicaments et DM
  • Europe – MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
  • Europe – Clinical performance studies with companion diagnostic (CDx) devices
  • Europe – Health Technology Assessment: Informal deal between Council and European Parliament
  • Europe – Mon logiciel est-il un dispositif médical en vertu du règlement européen ?
  • USA – FDA explains when device ‘servicing’ becomes ‘remanufacturing’
  • China – Chinese regulatory bodies provide updates on revised medical device regulations
  • Europe – European Medical Device Nomenclature (EMDN) : Q & A
  • Singapore – COVID breathalyzer tests win provisional authorization in Singapore
  • Europe – Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID
  • USA – Testing for Biotin Interference in In Vitro Diagnostic Devices
  • Europe – IVDR: MDCG charts rollout in new implementation plan
  • Europe – May’s Regulatory Focus: EU MDR and EU IVDR update, and more
  • Australia – Australian Conformity Assessment Body (AU CAB) applications begin in July
  • Europe – MDCG 2021-11 Guidance on Implant Card – ‘Device types’
  • Europe – IVD devices: From performance evaluation studies to clinical performance studies, what has changed?
  • UK – Using the UKCA marking
  • Europe – MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN)
  • Europe – MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
  • Europe – Euro Roundup: Switzerland moves to mitigate split from EU on device regulation
  • USA – FDA authorizes new device to help diagnose pediatric autism
  • USA – US FDA considers updating labeling requirements for medical implants with metal components
  • Singapore – Singapore HSA releases draft guidance on medical device UDI system
  • Europe – Industry and patient groups call for IVDR delay
  • Europe – MDCG 2021-09 : Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
  • Australia – Medical devices reforms: Conformity assessment bodies
  • Canada – Medical Devices Action Plan: Progress report
  • USA – FDA issues new draft guidances on device postmarket surveillance
  • UK – MHRA updates device guidance as MDR takes effect in Northern Ireland
  • Europe – Medical Device Regulation comes into application
  • Asia – Asia-Pacific Roundup
  • Switzerland – Placing medical devices on the Swiss market after the EU MDR Date of Application
  • Europe – Strategic lifecycle approach to medical device regulation
  • USA – Eurofins’ COVID-19 test for children receives EUA
  • USA – FDA issues final medical device safety guidance for MRI
  • Australia – TGA publishes guidance documents for reclassified medical devices
  • USA – CDRH seeks feedback on proposed materials labeling framework
  • Europe – MDCG 2021-08 : Clinical investigation application/notification documents
  • USA – FDA finalizes brain-computer interface guidance, issues draft for glycemic control devices
  • USA – FDA pushes back deadline for removal of legacy identifiers to 2023
  • Europe – 2021 : les nouvelles pratiques de la recherche clinique sur les DM
  • Europe – Prothèses mammaires PIP : le certificateur TÜV reconnu coupable par la cour d’appel de Paris
  • Thailand – New Thai medical device regulations increase technical data requirements
  • Australia – Including IVD medical devices in the ARTG
  • Europe – « UDI Helpdesk est en ligne ! »
  • Australia – Presentation : EU Medical Device Regulation: Implications for the TGA and Australia
  • Europe – MDCG 2021-7 : Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
  • USA – Skin cancer detection device gets breakthrough status
  • USA – FDA OKs overnight lens for myopia management from J&J Vision
  • International – Early cancer detection blood test developed by Tzar Labs
  • USA – FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices
  • Australia – Medical devices reforms: Reclassification of certain medical devices
  • China – Medical device adverse event reports increase by 35% in China
  • Europe – Proposal for a Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act)
  • Europe – Dispositifs médicaux : manuels en ligne remplaçant les instructions sur support papier
  • Europe – MEP: E-cigarettes have a place in EU cancer plan, but we must remain vigilant
  • Taiwan – Taiwan update: Classification scheme, final fee schedule, post-market surveillance measures
  • Europe – MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
  • USA – FDA issues warning for unauthorized COVID-19 tests
  • Switzerland – Consultation open for Swiss ordinance governing IVD products
  • Europe – Bruxelles veut faire confiance à l’IA
  • Europe – Factsheet for Class I Medical Devices
  • Europe – Euro Roundup: UK says local plasma is acceptably safe in immunoglobulin medicines
  • Europe – European Commission issues MDR Q&A document on medical device clinical investigations
  • Taiwan – TFDA makes further announcements regarding new medical device regulations and fees
  • Japan – Japan PMDA issues guidance on package insert digitization requirements
  • Europe – Caractérisation des nanomatériaux dans les DM : état des lieux
  • UK – Register medical devices to place on the market
  • Europe – MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI
  • India – India CDSCO delays regulation deadline for implantable medical devices
  • USA – COVID test EUAs updated with pooled serial testing option
  • USA – MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations
  • Europe – MDCG 2021-6 : Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
  • Eruope – Normes harmonisées relatives aux DM et DMDIV
  • Vietnam – Vietnamese Ministry of Health proposes new decree for medical device regulation
  • USA – FDA issues final rule removing certain software from medical device regulations
  • Europe – Euro Roundup
  • Europe – MDCG 2021-5 Guidance on standardisation for medical devices
  • USA – US FDA announces medical device testing laboratories accredited under ASCA program
  • USA – Federal officials design new mask guidelines to better protect more workers
  • Europe – La CE propose un “Webinaire pour les patients – Des dispositifs médicaux sûrs et performants pour tous”
  • Taiwan – TFDA releases details about transition to new Taiwanese medical device regulations
  • Australia – The regulation of medical device software, February 2021 : TGA presentation
  • Asia – Asia-Pacific Roundup
  • USA – FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer
  • Europe – MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
  • USA – How to reduce bias, improve fairness in medical devices
  • USA – US FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview
  • USA – US FDA outlines next steps following COVID-19 Pandemic Recovery and Preparedness Plan (PREPP)
  • Europe – Evaluation renforcée des DM par des panels d’experts: la CE donne le feu vert
  • China – NMPA publishes guidelines for Device Master File (DMF) submissions
  • Europe – Eurofins Expert Services Oy est le 20ème ON
  • USA – HHS’ proposed 510(k) exemption proves the need for regulatory science
  • Brazil – Brazilian regulators update economic monitoring requirements for some medical devices
  • Australia – Clinical evidence guidelines: Medical devices
  • USA – US FDA to stop authorizing new imported respirators under reissued Emergency Use Authorization
  • USA – HHS proposes updates to patient labeling, BA/BE study regulation
  • China – NMPA publishes revised Chinese medical device regulations
  • USA – FDA okays first-in-world valve to address congenital heart disease
  • USA – Bending the arc of testing for COVID – and beyond
  • USA – US FDA unveils online resource center for biocompatibility assessment
  • Australia – TGA posts guidance to support self-testing for infectious diseases
  • USA – Device, digital health firms oppose HHS’ proposed 510(k) exemptions
  • Europe – Le Code de conduite RGPD des essais cliniques rédigé par l’EUCROF a été soumis le 17 mars à la CNIL
  • Europe – Is your softawre is a medical device ?
  • USA – US FDA publishes EUA templates for COVID-19 IVD submission
  • UK – Groundbreaking new technology to detect known variants of concern
  • Canada – Canadian researchers developing COVID-19 breath test
  • Switzerland – Swissmedic : New requirements and changes to authorisation practice as of May 2021
  • USA – FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
  • Canada – Foreign risk notification for medical devices guidance document
  • Singapore – Singapore HSA will require government accreditation for certification bodies issuing ISO 13485 certificates
  • USA – FDA issues safety warning for ankle replacement device
  • USA – FDA smooths the path for COVID screening tests
  • Europe – MDCG 2021-2 : Guidance on state of the art of COVID-19 rapid antibody tests
  • Europe – Disposer d’une couverture financière suffisante au regard du risque produit : une nouvelle obligation
  • Australia – Australia will develop UDI system for medical devices following new regulatory amendment
  • Europe – MDCG 2021-3 : Questions and Answers on Custom-Made Devices
  • USA – MCIT: Not a better way to pay for breakthrough devices
  • Europe – A Notified Body’s perspective on the clinical evaluation requirements under Regulation (EU) 2017/745 on medical devices
  • UK – Intérêt d’une approche guidée par un outil numérique d’aide à la décision et adaptée à des troubles anxiodépressifs sévères
  • Taiwan – New Taiwanese medical device regulations set for May 2021
  • Philippines – Guidelines released for transition in Philippines to ASEAN harmonized requirements
  • China – NMPA reports detail Chinese regulatory activities in 2020
  • USA – Trials without clinical sites offer chance for improved access, generalizability
  • UK – Guidance : Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
  • USA – COVID-19: FDA offers guidance on container closure switches
  • Canada – Publication of second Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users
  • USA – NIH to evaluate COVID-19 at-home testing system
  • Europe – MDCG 2021-1 : Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
  • USA – FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy
  • UK – UK passes post-Brexit medical device regulatory bill into law
  • UK – Guidance : Managing medical devices – Update
  • Australia – Regulatory framework for personalised medical devices: Frequently asked questions
  • India – Indian regulators propose use of American Standard Test Methods for medical device conformance
  • USA – FDA: Oximeters may be inaccurate in Black patients
  • USA – FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use Device
  • Australia – Clinical decision support software
  • USA – CDRH officials dissect early-pandemic test guidance missteps
  • Europe – Un 19ème organisme notifié au titre du RDM
  • Norway – Norwegian language requirement will apply following MDR implementation
  • Europe – EC : Management of Legacy Devices – MDR EUDAMED
  • UK – UK regulators publish new details on streamlined medical device clinical study review program
  • Europe – Replay : Séminaire EMA relatif à l’article 117 du Règlement DM UE 2017/745 modifiant la directive 2001/83/CE
  • USA – Medtech cybersecurity chief named by FDA
  • Canada – Health Canada clarifies Minister of Health’s product safety enforcement powers
  • USA – CDRH plans full ASCA pilot implementation, for 2021
  • USA – La FDA présente son plan pour réglementer les logiciels embarquant de l’IA
  • USA – FDA expands approval for migraine neuromodulation device
  • USA – HFE for over-the-counter medical devices and combination products: Nice to have or necessary?
  • USA – US FDA ramping up permanent 510(k) exemptions for dozens of low-risk medical devices
  • Australia – TGA carves out exemptions for some software-based medical devices
  • USA – Woodcock takes charge as acting FDA commissioner
  • China – Chinese regulators announce classification adjustments and UDI submission guidelines
  • Brazil – New Brazil INMETRO ordinance eases inspection and documentation requirements
  • USA – FDA : Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Action Plan
  • Australia – Regulation of software based medical devices : Update
  • Canada – Guidance on summary reports and issue-related analyses for medical devices: Overview
  • UK – Medicines and Medical Devices Bill: overarching documents
  • Australia – Face masks and COVID-19
  • USA – HHS pushes through last-minute policies impacting FDA
  • Europe – DM : La veille réglementaire et normative en un clin d’œil
  • USA – FDA lays out 2021 regulatory science areas of focus
  • Europe – Covid-19: Commission Notice on audits to be performed by notified bodies
  • USA – FDA: COVID-19 variants may affect molecular test results
  • Europe – Nouvel Organisme Notifié habilité au titre du RDM : SGS FIMKO OY, Finlande
  • UK – Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator
  • UK – Guidance – Designated standards: in vitro diagnostic medical devices
  • UK – Guidance Designated standards: medical devices
  • UK – Guidance – Designated standards: active implantable medical devices
  • UK – Medical devices: UK approved bodies
  • UK – MHRA : New guidance and information for industry from the MHRA
  • UK – UK MHRA issues post-Brexit medical device, IVD registration requirements
  • USA – US FDA provides extra response time for device submissions on hold and expands virtual options
  • Europe – What’s in the Brexit trade deal for the pharmaceutical and medical device industries?
  • USA – Guidance : Safer Technologies Program for Medical Devices
  • Canada – Importation and sale of medical devices for COVID-19 guidance document
  • Europe – CARMAT s’envole en bourse après le marquage CE pour son cœur artificiel
  • Canada – New regulations strengthening the post-market surveillance and risk management of medical devices in Canada
  • USA – FDA extends timeline for device submissions on hold during pandemic
  • Europe – « Cœur CARMAT » : Indication et population cible
  • Australia – TGA confirms nicotine e-cigarette access is by prescription only
  • China – NMPA guidances address real-world data, medical device naming, and IVD technical review
  • France – Une solution de gestion automatisée pour le diabète hautement instable
  • USA – FDA Approves Prosthetic Implant for Above-the-Knee Amputations
  • Europe – Euro Roundup
  • Europe – MDCG ongoing guidances – December 2020
  • USA – FDA Develops Fecal Test for COVID-19
  • France – Des DM, des données et de l’IA: la recette d’Implicity pour révolutionner la télécardiologie
  • Europe – Article 59 and European CE Marking for medical devices
  • Australia – TGA requires Declaration of Conformity in ARTG applications for Class 1 IVDs
  • Europe – MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
  • USA – Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19
  • UK – MHRA post-transition period information
  • Europe – EU OKs Alzheimer’s blood test from C2N
  • Europe – Enregistrement des Acteurs français dans Eudamed
  • France – BREXIT : fin de la période de transition au 31 décembre 2020
  • Europe – EC Q&A clarifies guidelines for medical device remote audits
  • USA – FDA posts final guidance on device-specific performance criteria
  • Europe – MDCG 2020-17 : Q&A on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions.
  • Europe- Une intelligence artificielle permet de détecter plus rapidement des cas critiques sur radio thoracique
  • Australia – Evidence requirements for face masks that are medical devices
  • UK – Guidance : Register as a manufacturer to sell medical devices
  • International – Asia-Pacific Roundup
  • Europe – Medical device clinical studies with medical devices and Brexit: Sponsors may suddenly become non-EU
  • UK – Medical devices given exceptional use authorisations during the COVID-19 pandemic
  • Europe – Pressions sur l’UE pour décaler la date d’application du RDMDIV
  • Australia – Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices
  • USA – Device shortage guidance gets a COVID update from FDA
  • Europe – Eudamed actor module FAQ now live
  • USA – Roche’s anti-SARS-CoV-2 antibody test granted EUA
  • France – COVID-19: Evaluation of diagnostic testing methods and devices
  • France – COVID-19 : cadre dérogatoire de nouveau en vigueur, pour la prise en charge des IVG médicamenteuses
  • USA – FDA details feedback request process for combo products
  • Europe – TÜV Rheinland Becomes 5th Notified Body Designated Under MDR
  • Australia – Priority applicant guidelines for medical devices (including IVDs)
  • Canada – New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19)
  • Mexico – Mexican regulators set aggressive new deadlines for medical device equivalency route approvals
  • Australia – Regulatory changes for custom-made medical devices
  • Australia – Guidance : Medical device patient information leaflets and implant cards
  • USA – US FDA introduces Certificate for Device Not Exported from the United States (CDNE)
  • Europe – EU expands use of BioMerieux COVID-19 test
  • Brazil – Brazil OKs COVID-19 test from Chembio Diagnostics
  • USA – At-home COVID-19 test kit from Lucira Health gets EUA
  • Malaysia – Malaysia MDA introduces new searchable medical device database
  • Taiwan – TFDA outlines new UDI requirements for medical devices in draft guidance
  • USA – Device sponsors get detailed electromagnetic compatibility guidance from FDA
  • Europe – Euro Regulatory Roundup
  • Europe – MDCG 2020-16 : Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
  • USA – Coronavirus : une appli serait capable de repérer l’infection en analysant la toux
  • USA – FDA finalizes guidance on microneedling devices
  • China – China’s NMPA approves 2 rapid COVID-19 antigen tests
  • Europe – La nouvelle certification CE permettra une plus grande utilisation des dispositifs médicaux personnalisés imprimés 3D
  • USA – Guidance : Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
  • Taiwan – TFDA suspends on-site inspections for foreign medical device manufacturers
  • UK – NICE launches consultation on its methods of drug evaluation
  • USA – First COVID neutralizing antibody test okayed by FDA
  • Europe – Euro Regulatory Roundup
  • Europe – Euro Convergence: Experts share advice, concerns and expectations for IVDR
  • UK – Brexit and the UK’s medical device usability requirements
  • Taiwan – Taiwan regulator releases draft guidances for medical device vigilance reporting
  • Europe – Euro Convergence: Pragmatic approaches to data collection needed to meet MDR
  • Singapore – HSA will introduce UDI labeling requirements for medical devices
  • Europe – SCHEER : Preliminary Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma
  • USA – US FDA presents premarket submissions pilot program and patient-centered data resource pages
  • Europe – EUDAMED : Actor registration module
  • Europe – Are your clinical activities in compliance with European standards for good clinical practice principles and national regulations?
  • USA – CDRH FY 2021 guidance slate includes post-EUA transition plan
  • UK – Medical Devices Safety Bulletin
  • USA – FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices
  • USA – FDA finalizes biotin interfering testing guidance
  • USA – During pandemic, FDA permits some respiratory swab, media swaps
  • China – Chinese regulators delay medical device UDI implementation
  • Brazil – ANVISA publishes list of exempted healthcare products and cybersecurity guide
  • Australia – TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID
  • Europe – Swiss referendum leaves MDR mutual recognition agreement question unresolved
  • Australia – New compliance dashboard for post-market medical device reviews
  • China – China asks for global distribution of its COVID-19 vaccines
  • India – Researchers in India develop paper-strip COVID-19 test
  • Canada – Guidance : Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications
  • Europe – MHRA provides more insights into Brexit preparations
  • USA – US FDA ASCA Program: How the new Accreditation Scheme for Conformity Assessment pilot will work for medical device premarket reviews
  • USA – US FDA publishes trio of final guidances for Accreditation Scheme for Conformity Assessment (ASCA) program
  • UK – Medical devices given exceptional use authorisations during the COVID-19 pandemic
  • Europe – Countdown to EU MDR and IVDR
  • Brazil – ANVISA suspends expedited registrations for COVID-19 products
  • USA – An assessment of the proposed rule to change US FDA’s interpretation of Intended Use
  • UK – How tests and testing kits for coronavirus (COVID-19) work
  • USA – FDA finalizes blood glucose monitor guidances
  • South Korea – South Korea’s MFDS publishes draft regulatory revision and new guidance documents
  • USA – FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants
  • Switzerland – Swiss Medtech demande une solution rapide et pragmatique pour l’industrie de la technologie médicale
  • USA – FDA finalizes ASCA pilot guidance as it gears up for launch
  • USA – US FDA releases draft guidance on patient-reported outcome instruments
  • Europe – GMED : Evaluation Biologique des Dispositifs Médicaux selon la Norme ISO 10993-1
  • Japan – Japan PMD Act revisions include fast-track reviews for some medical devices and IVDs
  • UK – Brexit Readiness Checklist for companies doing business with the UK
  • Brazil – ANVISA eliminates Cadastro pathway for Class II medical devices
  • Europe – Un 17ème Organisme notifié habilité au titre du RDM (3EC International SLOVAKIA)
  • Australia – Australia to permit some self-test IVDs after industry calls for change
  • Europe – MDR/IVDR update: Experts share what keeps them up at night
  • USA – Voluntary consensus standards guidance updated by FDA
  • USA – FDA updates Pre-Cert pilot for SaMD
  • USA – FDA clarifies EUAs for COVID multi-analyte respiratory panels
  • India – India’s CDSCO proposes extensive risk classification lists for medical devices and IVDs
  • USA – Self-selection Studies: Guarding against contraindicated use of OTC medical products
  • China – Medical device usability testing in China: Key considerations for manufacturers
  • USA – Use of International Standard ISO 10993-1, « Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process »
  • USA – US FDA publishes FAQs on registering and importing devices during COVID-19
  • Mexico – Mexican medical device regulators move to electronic appointment system to reduce risk of coronavirus exposures
  • Europe – Interprétation de l’évaluation clinique : orientations de la CE à l’intention des groupes d’experts
  • UK – Regulating medical devices from 1 January 2021
  • UK – MHRA posts suite of post-transition guidances
  • USA – Registration and Listing of Medical Devices during the COVID-19 Pandemic
  • USA – FDA releases draft guidance on PROs for device manufacturers
  • USA – Combination products: FDA releases PDUVA VI program report
  • USA – Rapid standalone COVID antigen test nabs EUA
  • Canada – Testing devices for COVID-19: test swabs safety and effectiveness guidance
  • Canada – Regulatory considerations for importing or selling face shields
  • USA – US FDA identifies first two medical device types eligible for new streamlined 510(k) registration
  • Europe – European Commission sets common specifications for reprocessing single-use devices
  • USA – FDA revokes umbrella EUA for some patient barrier enclosures
  • USA – HHS blocks FDA regulation of some lab tests
  • Australia – Medical device definitions and requirements for system or procedure packs : Update
  • USA – FDA qualifies decision tool for breast reconstruction studies
  • Europe – MDCG 2020-15 : Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number in the Member States
  • Europe – Updated European UDI FAQ features revised compliance deadlines
  • Europe – Understanding sufficient clinical evidence requirements under the European Medical Devices Regulation
  • USA – FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic
  • USA – FDA issues warning for unauthorized at-home COVID-19 tests
  • USA – Medical devices in shortage listed by FDA
  • USA – FDA finalizes penalties for trial reporting violations
  • USA – FDA proposes down-classifying bone grown stimulators
  • USA – FDA finalizes first device-specific safety and performance based pathway guidances
  • USA – Device importers’ COVID questions answered by FDA
  • Europe – European Commission identifies which Eudamed data to be publicly accessible
  • Europe – MDCG 2020-14 : Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the MDR/IVDR
  • Europe – Researchers develop fast triple antibody test
  • Europe – MDCG explains how notified bodies can use MDSAP audit reports
  • USA – Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices
  • USA – Pandemic prompts mask, ventilator EUAs from FDA
  • USA – US FDA launches pilot program for RFD and Pre-RFD electronic submissions process
  • Europe – Euro Regulatory Roundup
  • Australia – TGA advises on 3D-printed device risks
  • International – Robot conducts nasal swab tests
  • USA – FDA Purple Book Database now includes all CBER-, CDER-licensed biological products
  • USA – FDA authorizes first two semi-quantitative COVID-19 serology tests
  • USA – Lawmakers introduce EtO monitoring bill
  • UK – Roll-out of 2 new rapid coronavirus tests ahead of winter
  • USA – FDA clarifies pooled sample, multi-analyte coronavirus EUAs
  • Europe – Instructions For Use for reusable and re‐sterilisable Medical Devices
  • USA – Multiple Function Device Products: Policy and Considerations
  • Europe – MDCG 2020 – 13 : Clinical evaluation assessment report template
  • India – Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices
  • Canada – Regulatory considerations on the classification of non-medical masks or face coverings
  • Australia – Delays to the commencement of certain medical device regulatory changes
  • USA – FDA exempts additional Class II devices from 510(k) requirements
  • France – Des textiles intelligents grâce à des lignes de transmissions souples
  • Europe – The European MDR and human factors engineering: Evaluation of User Interface of Unknown Provenance (UOUP)
  • Europe – Guidance document on Aquatic and Sediment Toxicological Testing of Nanomaterials
  • Europe – Guidance Document for the testing of Dissolution and Dispersion stability of Nanomaterials and the use of the Data for further Environmental testing and Assessment strategies
  • Europe – Overview of REACH information requirements and available methods
  • Switzerland – Switzerland approves MedDO revision and moves toward MDR harmonization
  • USA – US FDA 2020 agenda includes ISO 13485 harmonization, De Novo classification scheme
  • Europe – Updates on MDR implementation, transparency; MDCG posts CEAR template
  • Australia – Actual and potential harm caused by medical software
  • USA – FDA issues final guidance for electronic submissions
  • Europe – MDCG 2020-13 : Clinical evaluation assessment report template
  • UK – Is your App a medical device? It’s healthy to know: regulator issues updated guidance
  • USA – FDA recommends changes to 2 final device guidelines
  • Europe – IMDRF – Personalized Medical Devices – Regulatory Pathways
  • UK – UK MHRA publishes list of exempted medical devices
  • USA – US FDA extends UDI deadlines for low-risk medical devices
  • Malaysia – Malaysia’s MDA publishes post-market surveillance guidance documents
  • USA – Unified agenda: FDA publishes lengthy to-do list
  • Europe – MDR Watch: 14 Notified Bodies now designated under EU Medical Devices Regulation
  • Europe – European Commission publishes survey results on Notified Body COVID-19 capacity
  • Europe – Brexit update: No extension of the transitional period
  • Europe – GMED : guide de certification en vue du marquage CE, Règlement UE 2017/745 (version de Juin 2020)
  • Europe – EC details device assessment capacity amid COVID-19
  • Europe – RDM : quelles responsabilités pour les différents opérateurs économiques ?
  • Europe – L’importance du niveau de preuve des données cliniques dans le RDM
  • Australia – TGA releases new fee schedule and announces reform delays
  • USA – Impact of COVID-19 emergency on US FDA interactions with medical device manufacturers
  • USA – Guidance : Review and Update of Device Establishment Inspection Processes and Standards
  • USA – UDI : Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
  • USA – FDA : Guidance Documents – Recently Issued
  • Europe – MDCG 2018-3 Rev.1 (June 2020) Guidance on UDI for systems and procedure packs.
  • USA – FDA issues final guidance on inspections of medical device establishments
  • USA – Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers
  • USA – Fauci: US won’t slow down COVID-19 testing
  • Europe – Quelle responsabilité attachée aux logiciels dispositifs médicaux ?
  • USA – FDA explains COVID-19 impact on MDUFA goals, meetings
  • USA – Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers
  • USA – FDA guidance offers statistical advice for clinical trials
  • USA – New accelerator to boost real-world COVID-19 diagnostics
  • UK – Researchers develop highly sensitive blood test for cancer
  • USA – US FDA clarifies adverse event reporting requirements for medical devices designated under Emergency Use Authorizations
  • Europe – Un 4ème ON désigné pour le Règlement DMDIV
  • China – New procedures released for medical device registration in China
  • Europe – NANDO : la base de données de la CE sur la règlementation et les organismes notifiés des DM & DMDIV
  • Europe – European Commission issues decision on harmonized standards for MDR, IVDR
  • Europe – MedTech Europe guidance for assigning Basic UDI-DI
  • Australia – Proposed delayed commencement of certain medical device regulatory changes
  • USA – First video game-based treatment gets go ahead from FDA
  • International – Self-Administration: What Drug-Delivery Device Manufacturers Should Know
  • USA – FDA grants first EUA for COVID next-generation sequencing
  • Europe – MHRA puts speed-to-market at center of post-Brexit vision
  • Europe – MDCG 2020-12 : MDCG 2020-12 : Guide relatif aux DM combinés à un substance active médicamenteuse ou conteant des tissus d’origine animale
  • Europe – RDM : AFNOR Certification se lance dans la course à l’habilitation
  • Europe – MDR delay impact extends beyond European Union
  • Europe – The European MDR and human factors engineering: Designing user-friendly software user interfaces and informational resources
  • France – L’union fait la force en règlementaire
  • USA – Devices Will Play A Greater Role in COVID-19
  • USA – FDA expands guidance on remote monitoring devices for COVID-19
  • Europe – Two Notified Bodies have officially withdrawn from providing CE Mark certifications
  • Canada – Health Canada adds private labels to scope of REP pilot program
  • Europe – MDCG n°11 : Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation.
  • UK – Action taken to halt sales of fingerprick coronavirus (COVID-19) antibody testing kits
  • Canada – Health Canada releases guidance to streamline COVID-19 clinical trials
  • USA – US FDA to temporarily accept changes to devices approved through PMA or HDE
  • Europe – European Commissioners loosen some MDD, AIMDD designation renewal requirements for Notified Bodies
  • Europe – Medical devices: guidance for manufacturers on vigilance
  • USA – FDA issues guidance on PMA, HDE supplements amid COVID-19
  • UK – Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices
  • USA – Standalone at-home COVID-19 nasal swab kit receives EUA
  • South Korea – South Korea adds renewal requirement for new medical device authorizations
  • Europe – COVID-19 et DM : Lignes directrices de la CE concernant l’adoption de dérogations
  • Europe – New Manufacturer incident report 2020
  • USA – FDA updates clinical trial guidance for drugs, devices
  • Europe – Intertek Medical Notified Body AB, 14ème Organisme notifié habilité au titre du RDM
  • Europe – MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
  • Europe – Eudamed update: Phased implementation planned for European medical device, IVD database
  • USA – Guidance : Clinical Trial Imaging Endpoint Process Standards
  • USA – FDA authorizes first antigen test for COVID-19, updates EUA templates
  • Australia – Post-market evaluation of serology-based point of care tests
  • USA – FDA Authorizes First COVID-19 Test Using Saliva Collected at Home
  • USA – FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection
  • USA – FDA abandons proposal for devices referencing drugs
  • USA – CDRH explains notification requirements for device shortages under CARES Act
  • Europe – EU device regulations, COVID-19 response and global regulatory strategy
  • Australia – Australia’s TGA publishes new guidances and consultation results
  • Europe – CE certificates up nearly 50% in 2019 in anticipation of MDR
  • China – Chinese government bodies introduce further COVID-19 responses
  • USA – FDA tightens oversight of antibody tests for COVID-19
  • USA – FDA creates umbrella emergency pathway for COVID-19 serology tests
  • Australia – Post-market review of face masks
  • Europe – Garantir la conformité au RDM des dispositifs avec assemblages électroniques
  • Mexico – COFEPRIS releases guidelines on priority devices amidst partial COVID-19 shutdown
  • USA – FDA Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions
  • UK – Major home testing programme for coronavirus will track levels of infection in the community
  • Brazil – ANVISA introduces temporary measures to combat COVID-19 in Brazil
  • USA – FDA seeks to expand use of remote digital pathology devices amid pandemic
  • USA – FDA drafts guidance on emergency-use injector reliability
  • Europe – MEDCERT : le 13ème ON au titre du Règlement UE 2017/745 (RDM), il porte le numéro NB 0483.
  • Europe – Le report d’un an du RDM publié en urgence au JOUE du 24 Avril 2020
  • Canada – Guidance : Requirements for serological antibody tests submitted under the COVID-19 Interim Order
  • Europe – Covid-19 : fin avril 2020, les tests diagnostiques biologiques sont nombreux, mais souvent peu performants
  • Europe – MDCG 2020-8 : Post-market clinical follow-up (PMCF) Evaluation Report Template
  • Europe – MDCG 2020-7 : Post-market clinical follow-up (PMCF) Plan Template
  • Europe – MDCG 2020-6 : Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC
  • Europe – Le report du RDM est publié au JOUE
  • Europe – Comment maîtriser la sous-traitance dans le cadre du RDM ?
  • Europe – Solution de gestion des données cliniques issues de DM d’imagerie
  • Europe – MDR delay moves forward as industry calls to push back IVDR
  • Europe – Guidelines on COVID-19 in vitro diagnostic tests and their performance
  • USA – Optimizing remote internal quality audits
  • Europe – The European MDR and human factors engineering: Use-related risks
  • Europe – COVID-19 IVD quality problems drive EC guidelines
  • Australia – Medical device labelling obligations
  • USA – FDA Grants EUA to First Saliva-Based Coronavirus Test
  • Europe – Passage à la loupe des paramètres laser en vue d’un marquage UDI conforme
  • USA – Guidance : Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
  • USA – FDA Authorizes Blood Purification Device to Treat COVID-19
  • USA – FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators
  • France – Coronavirus : interruption de l’essai clinique avec du sang de ver marin
  • Europe – RDM : le Conseil de l’Europe valide la demande de report d’un an de la Commission
  • Europe – MDCG 2019-3 Rev.1 : Interpretation of Article 54(2)b
  • Europe – Notified Body Audits During the Pandemic: New MDCG Guidance
  • Europe – COVID-19 in Europe: Emergency market access for PPE, medical device and IVD manufacturers
  • India – India’s CDSCO responds to COVID-19 with new approval, import, and safety measures
  • Europe – Eudamed’s Delay and its Impact on Clinical Investigations Under the EU MDR
  • Europe – Organismes Notifiés et RDM : le point à date
  • USA – FDA Offers Expanded Use for ECMO, Cardiopulmonary Bypass and Ophthalmic Devices Amid COVID-19
  • China – NMPA Seeks to Ensure Quality of Exports as China Becomes Key Supplier of COVID-19 Devices
  • USA – Has FDA relaxed its human factors expectations in response to the COVID-19 pandemic?
  • USA – Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
  • Europe – Proposition de la Commission Européenne au Parlement pour reporter d’un an la d’application du RDM
  • Europe – Launch of TEAM-PRRC : Persons Responsible for Regulatory Compliance
  • Europe – EU Regulatory Roundup
  • USA – BARDA opens research portal to combat COVID-19 pandemic
  • Europe – Contaminants inorganiques : les atouts des méthodes d’analyse spécifiques (Ref. norme ISO 19227)
  • USA – What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests
  • USA – Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  • USA – Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency
  • Europe – Evaluation biologique des dispositifs médicaux : de la méthodologie à la pratique
  • France – Piles à combustibles bio-enzymatiques : une source d’énergie naturelle
  • France – Organoïdes: des mini-organes au service de la recherche
  • France – Impression 3D : pas seulement les implants
  • Europe – Normes Européennes Harmonisées : Mise à jour Mars 2020
  • UK – UK announces COVID-19 regulatory response measures
  • Europe – Coronavirus: harmonised standards for medical devices to respond to urgent needs
  • USA – FDA Lifts Requirements for Masks, Respirators, Looks to Reprocessing to Ease Shortages
  • USA – COVID-19 Response: What manufacturers should know about US FDA Emergency Use Authorizations (EUA) for medical devices and IVDs
  • USA – FDA Eases Import Requirements for Devices and PPE to Fight Coronavirus
  • Europe – The European MDR and human factors engineering: Intended purpose
  • Europe – EU guidance documents offer additional details on MDR transition
  • Europe – Implementation of the MDR most likely postponed by one year
  • Europe – Vers un report du RDM d’un an ?
  • USA – New blood test may detect SARS-CoV-2 antibodies
  • USA – FDA urges device companies to report shortages
  • Europe – MedTech Europe calls for a pause on IVDR and MDR implementation to facilitate the fight against COVID-19 and to safeguard Healthcare Systems
  • USA – FDA Offers Flexibility for Changes to Non-Invasive Remote Monitoring Devices During Pandemic
  • USA – Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance
  • Australia – TGA suspends overseas GMP inspections and QMS audits until further notice
  • Europe – Les modalités pratiques de l’Ingénierie d’Aptitude à l’Utilisation dans le DM
  • China – Hong Kong regulator will continue to recognize South Korean approvals
  • Europe – MDCG 2020-3 : Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
  • Europe – Trois nouvelles guidances du MDCG en Mars 2020
  • Europe – COVID-19 et évaluation de la conformité des DM : La position de la Commission Européenne
  • Europe – As coronavirus roils region, EU device body adamant about steps to hit MDR deadline
  • Europe – MDR Eudamed (IT updates), March 2020
  • Europe – Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020
  • Europe – CLASSIFICATION DES DM : Comparaison DDM/RDM
  • Europe – EXIGENCES DE CONFORMITE : Comparaison DDM/RDM
  • UK – Advice for Management of Clinical trials in relation to Coronavirus
  • USA – FDA finalizes contentious guidance on third party 510(k) reviews
  • USA – FDA chief warns of supply ‘pressure’ on reagents for coronavirus tests
  • USA – Proposed Legislation Targets a Critical Regulatory-Reimbursement Gap for Medical Devices
  • Brazil – ANVISA will implement new rules for medical device modifications in Brazil
  • USA – Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
  • UK – New genetic test could pick out ‘high risk’ bone marrow cancer patients
  • Asia-Pacific – COVID-19 outbreak triggers regulatory interventions in Asia-Pacific region
  • Europe – An Update on ISO 11607 and EU MDR
  • USA – This Robot Gives Birth and We Can’t Stop Watching
  • Europe – The European MDR and human factors engineering: Introduction
  • USA – FDA Warns of Cybersecurity Vulnerabilities in Pacemakers, Blood Glucose Monitors
  • USA – Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s
  • Canada – Access our Canada medical device regulatory chart in RAMS
  • UK – UK Parliament advances regulatory bill and publishes factsheets
  • USA – FDA head wants new reporting rule for medtech firms
  • USA – FDA warns of possible medical supply shortages
  • Australia – Update on reclassification of a number of medical devices
  • USA – Bone Anchors: FDA Finalizes 510(k) Guidance
  • USA – FDA Seeks to Make Laparoscopic Power Morcellators Safer
  • USA – FDA will test interactive 510(k) submission template
  • Singapore – Singapore HSA revises guidance and technical documents
  • China – China CMDE publishes guidance on generic medical device names
  • USA – Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
  • USA – Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
  • Europe – Co-Diagnostics Grabs CE Mark for Coronavirus IVD
  • Australia – Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
  • India – India Commits to Phased Overhaul of Medical Device Regulations
  • South Korea – Seegene’s COVID-19 test authorized for emergency use in Korea
  • Australia – Review of Medicines and Medical Devices Regulation (MMDR)
  • USA – Modernizing ClinicalTrials.gov: NIH Seeks Feedback
  • India – Update: Expanded scope of medical device regulations, plus new expedited registration route
  • Switzerland – Double peine pour la medtech suisse
  • USA – Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
  • UK – NICE recommends wireless device for overactive bladder
  • UK – UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul
  • USA – Atherectomy 510(k) guidance finalized by FDA
  • Europe – Eudamed : un report de 2 ans à mettre à profit pour mieux se préparer au RDM
  • USA – FDA issues progress report for ASCA medical device conformity assessment pilot
  • Asia – Asia Regulatory Roundup
  • Europe – Guide PSUR et MDCG ?
  • Australia – TGA : Researcher considerations for medical devices
  • Japan – Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard
  • Europe – Updated: Czech Notified Body Yet to Apply Under MDR as Others Prep for Post-May Designations
  • Europe – First Brexit, now Swexit?
  • Europe – Norway’s DNV GL Designated as 10th Notified Body Under MDR
  • Europe – Brexit happened. EU MDR looms. 3 key questions on medtech’s future in Europe
  • Europe – EC : Call for applications: observers for the Annex XVI sub-group of the medical device coordination group
  • Europe – Economic Operators: Roles and Obligations Under EU’s MDR
  • Europe – Norme ISO 10993-18 : analyse des extractibles et des particules
  • Europe – Un forum mondial de l’UDI à Berlin du 21 au 23 avril 2020
  • UK – What Happens to SPCs and Patents After the Brexit Transition Period
  • Europe – European Commission provides latest figures on Notified Body MDR, IVDR designations
  • South Korea – South Korea issues final revisions to regulations for medical device importation requirements
  • Philippine – Philippine FDA Issues Guidance on Medical Device Authorizations
  • China – China’s NMPA greenlights 4 coronavirus detection products
  • USA – FDA Drafts 510(k) Guidance for Arthroscopy Pump Tubing Sets
  • UK – MHRA Updates Guidance on Clinical Investigations of Devices
  • UK – Brexit Withdrawal Signed Ahead of UK’s 31 January Departure
  • Europe – MDCG’s 2020 Meetings to Tackle Clinical Data, Annex XVI, UDIs and More
  • Europe – EC: 3 More Notified Bodies to be Designated Soon
  • Switzerland – MDR Watch: Is Switzerland becoming a Third Country?
  • Europe – The Essential List of Regulatory Authorities in Europe
  • Europe – EMA recommendation on their consultation by a NB on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device or active implantable medical device
  • USA – FDA Classifies Three Radiology Devices Into Class II
  • Europe – European Commission issues new guidance on Eudamed medical device database nomenclature
  • USA – OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show
  • USA – Ces lentilles connectées qui affichent des informations en réalité augmentée deviennent une réalité
  • USA – The FDA is Recommending Transition to New Duodenoscopes
  • USA – US FDA recognizes latest edition of ISO 14971 as medical device consensus standard
  • USA – FDA Finalizes Guidance on Annual Reports for Approved PMAs
  • USA – CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters
  • China – Un hôpital chinois implante des vertèbres thoraciques imprimées 3D
  • Europe – Major Concerns Remain With MDR, Industry Group and Expert Warn
  • Europe – Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs
  • USA – US FDA issues updates to classification regulations, hires verification services
  • Asia – The Essential List of Regulatory Authorities in Asia
  • India – India Gives Device Manufacturers Another Year to Meet Drug Regulations
  • Finland – Finnish Medicines Agency Takes Over Device Regulation
  • Europe – MDCG 2019-16 Guidance on Cybersecurity for medical devices
  • Europe – Recommandations du Groupe de Coordination des DM (MDCG) : le SCAC se fait attendre
  • USA – Industry, doctors, patients diverge on FDA outline for breast implant labels
  • USA – 10 Medical Devices Recently Approved by FDA
  • Europe – Notified bodies MedCert, BSI gain new EU MDR and IVDR designations
  • USA – FDA publishes final list of 510(k)-exempt devices
  • Europe – Netherlands names BSI as IVDR notified body
  • USA – Institutional Review Board (IRB) submissions: Necessary for usability tests?
  • USA – FDA issues draft guidance on communications with combo product developers
  • USA – Proton therapy lowers risk of side effects for cancer patients, study says
  • USA – FDA has nonpublic list of TAVR-related deaths
  • USA – US FDA issues final rule on paper and electronic copies for medical device premarket submissions
  • Canada – Guidance : Software as a Medical Device (SaMD)
  • Australia – Australian TGA publishes Uniform Recall Procedure update
  • Europe – MDCG 2019-15 Guidance Notes For Manufacturers of Class I Medical Devices
  • Europe – New guidance on medical device sampling criteria, Notified Body coding for European MDR, IVDR
  • USA – Bridging for Drug-Device and Biologic-Device Combination Products
  • Europe – European Parliament Adopts Second Round of MDR, IVDR Corrigenda
  • USA – FDA proposes to end quarterly reporting of medical device decisions
  • USA – FDA to allow electronic premarket submissions in place of paper
  • Europe – Number 8: Dekra’s Dutch NB Designated Under MDR
  • Europe – Winding down to the EU IVD and Medical Devices Regulations Deadlines: The Finish Lines in Sight?
  • USA – Guidance : eCopy Program for Medical Device Submissions
  • USA – FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
  • Europe – Questions Linger With Swiss-EU MRA and Device Regulation
  • Australia – IVD companion diagnostics : Guidance on proposed regulatory requirements
  • Australia – Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
  • USA – FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy
  • Europe – MDCG 2019-14 Explanatory note on MDR codes
  • Europe – MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
  • Europe – EU Commissioner for Health: MDR’s May 2020 Deadline Won’t Change
  • USA – FDA issues details on framework for abbreviated 510(k) medical device review pathway
  • USA – Lawmakers ask FDA’s plans about OTC hearing aids rules
  • USA – FDA can’t regulate contrast agent as drug, judge rules
  • Europe – RDM : l’enfer est pavé de bonnes intentions
  • Europe – European Commission : Technical Guidance on UDIs
  • USA – Lawmakers Reiterate Call to Integrate UDIs With Insurance Claim Forms
  • USA – FDA grants breakthrough status to eye-tracking Parkinson’s test
  • Europe – European Parliament Committee Signs Off on Second Round of MDR, IVDR Corrigenda
  • USA – FDA seeks public comments on pediatric medtech applications
  • Europe – MedTech Europe slams EU over lack of preparation for MDR/IVDR
  • Europe – Eudamed’s 2-Year Delay: CAMD Executive Group Calls for Interim Solutions
  • USA – US FDA Medical Device Classification Primer
  • Europe – MDR : le dernier corrigendum (rectificatif) de la CE est paru
  • USA – Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis
  • USA – FDA launches pilot to speed new ethylene oxide sterilization methods
  • USA – FDA scheduled to ban behavior-control devices
  • Europe – With 6 months until new EU medical device rules, what’s the state of play?
  • Europe – Second MDR Corrigendum Targets Class I Devices
  • USA – 3-D Printed Casts Offer Patients Customized Solutions for Bone Breaks
  • CDRH Unveils Pilot Project for Sterilization Changes
  • Brazil – ANVISA: Nearly half of all Brazil GMP certificates now issued under Medical Device Single Audit Program
  • USA – CDRH to Survey Manufacturers in Prep for Device Shortages
  • USA – FDA delays medtech, drug proposed rulemakings
  • Europe – Un test pour détecter le risque de surdité induite par les antibiotiques chez les nourrissons
  • Brazil – Update: ANVISA readies change application system, lists top medical device regulatory priorities
  • Europe – Medica 2019 report: MDR readiness checklist ahead of May 2020 deadline
  • South Korea – South Korean MFDS reduces submission requirements for high-risk medical devices
  • Malaysia – Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export
  • USA – FDA approves first contact lens indicated to slow the progression of nearsightedness in children
  • Europe – EU MDR: The Challenge of Compliance by May 2020
  • France – Les défis de la conception de capteurs portables connectés
  • USA – Apple Deepens Medical Research Commitment Through New App
  • USA – Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
  • Switzerland – Swissmedic Details Plans to Align Combination Product Rules With EU
  • USA – FDA updates safety recommendations on biotin interference in lab tests
  • Europe – Call for Experts on Medical Devices – Extended
  • Europe – Nouvelle version 2019 du guide d’application de la directive « machine » 2006/42/CE
  • USA – CRADA report from UL and US VA: Procurement as driver of medical device cybersecurity
  • Europe – Renouvellement du marquage CE des DM et nouveau règlement européen
  • Europe – 2 Dutch notified bodies (BSI & DARE!!) win EU MDR nod, lifting industry tally to 7
  • USA – Trump Nominates Hahn to be FDA Commissioner
  • Europe – The new EU MDR and its impact on drug device combination products
  • USA – Singapore HSA issues new guidance on special authorization routes for medical devices
  • Malaysia – Malaysian MDA medical device regulatory changes underway
  • USA – 10 Ways Medtech Is Battling Breast Cancer
  • Danmark – Danish Medicines Agency Ramps Up Capacity in Medical Devices
  • India – India Plans to Bring All Medical Devices Under CDSCO Oversight in December
  • Europe – BSI UK Becomes Second NB Designated Under IVDR
  • Europe – Appel à experts pour le RDM et le RDMDIV
  • Europe – Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body
  • Europe – MDR/IVDR Guidance: MDCG Explains What’s Coming
  • USA – FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements
  • USA – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication
  • Brazil – Brazil’s ANVISA proposes updates to medical device, IVD registration requirements
  • India – Medical device, IVD regulatory updates announced by Indian CDSCO
  • USA – Newly Added Guidance Documents
  • Europe – Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) : Questions & Answers
  • USA – AAMI TIR102:2019
  • USA – Metals Used in Medical Devices
  • USA – Off-The-Shelf Software Use in Medical Devices
  • Europe – Désignation de groupes d’experts dans le domaine des dispositifs médicaux
  • Europe – Applicability of EHSR of the Machinery Directive (2006/42/EC) to Medical Devices
  • Europe – Directive DIV : une nouvelle spécification technique commune publiée
  • Europe – Guidance on the vigilance system for CE-marked medical devices : Breast Implants
  • Europe – Guidance on the vigilance system for CE-marked medical devices : Cardiac Implantable Electronic Devices
  • Europe – European Commission Expert Panels on Medical Devices and IN VITRO Diagnostic Devices
  • USA – Senators urge FDA to clarify difference between servicing, remanufacturing
  • Europe – MDCG 2019-6 v2 – Requirements relating to notified bodies : Questions and answers
  • USA – MCM-Related Guidance by Date
  • Europe – MDCG 2019-9 : Summary of safety and clinical performance – A guide for manufacturers and notified bodies
  • Europe – MDCG 2019-12 Designating authority’s final assessment form
  • France – Des lunettes connectées qui guident la pose d’une prothèse du genou
  • USA – FDA Addresses Questions on 510(k) Third-Party Review Program
  • Europe – Le « risk-based-monitoring » : une solution adaptée au dispositif médical
  • France – Valider le nettoyage, la désinfection et la stérilisation des DM réutilisables
  • France – DM « intelligents » : comment maîtriser les risques de responsabilités ?
  • USA – Researchers Find 15% of Trials Could be Replicated Using Real World Data
  • USA – FDA Clears First Rapid Diagnostic Test for Ebola
  • Inde – Nouvelle définition des dispositifs médicaux pour inclure les nébuliseurs et les seringues
  • Europe – MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
  • USA – CDRH Proposed Guidances for Fiscal Year 2020
  • USA – FDA Issues Two Final Guidances on Guidewires, Catheters and Delivery Systems
  • USA – FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials
  • Europe – MDCG 2019 -10 : Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
  • Brazil – Brazil’s ANVISA approves formal regulations for custom-made medical devices
  • Europe – Regulatory Strategies for EU MDR and IVDR Implementation
  • USA – FDA to Further Investigate Implantable Devices Containing Certain Metals
  • USA – FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software
  • USA – US FDA updates guidance for telehealth and digital products qualifying as medical devices
  • Europe – MDGC Guidances
  • USA – EPA requires firms to provide info on EO emissions
  • Europe – TÜV Rheinland Becomes 5th Notified Body Designated Under MDR
  • USA – Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
  • USA – Clinical Decision Support Software
  • Australia – Australian regulatory action on breast implants and breast tissue expanders
  • China – Graphene-Based Artificial Throat Could Help Mute People Speak
  • USA – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
  • India – India To Enhance Oversight Of Medical Devices
  • Europe – Fitbit Users in Europe Can Now Monitor their Heart Rhythms for Irregularities
  • USA – Electronic Device Submissions: FDA Drafts Guidance
  • UK – MHRA: Role of UK Responsible Person and Importer are the same
  • China – China Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme
  • USA – Patient Engagement in Device Trials: FDA Drafts Guidance
  • Europe – 27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR
  • USA – FDA Details Long-Awaited Standards Accreditation Pilot in New Draft Guidance
  • USA – First MDR Certificate Issued for Class III Device
  • USA – Safer Technologies Program for Medical Devices
  • USA – Not Quite a Breakthrough Device, FDA Introduces New Safer Technologies Program
  • UK – Regulating medical devices in the event of a no-deal Brexit
  • UK -Businesses supplying medicines and medical devices: preparing for Brexit
  • Europe – New details from European Commission on Expert Panels under MDR, IVDR
  • USA – CDRH releases Four Final 510(k) Guidances
  • Europe – EC Explains New MDR, IVDR Rules for Designating Expert Device Panels
  • Europe – EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante
  • USA – Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity
  • USA – FDA issues final guidance on de novo approvals
  • USA – De Novo Requests: FDA Finalizes Three Guidances
  • USA – Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations
  • USA – Humanitarian Use Device (HUD) Designations
  • USA – New Report Compares FDA Quality System Requirements With ISO 13485:2016
  • Europe – Implementation of IVDR and MDR Into National Legislation
  • UK – Deal or no deal: Key Brexit-related issues for medical device, IVD sectors
  • Mexico – Mexican regulators to require online submission of medical device import permit applications
  • Europe – AMDR comments on issues of EU single-use medical devices specifications
  • USA – How to produce more medical devices for kids
  • Europe – Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit
  • Europe – No-deal Brexit, more likely than not: Key issues for medical device, IVD sectors
  • China – Chinese NMPA publishes UDI system rules for medical device registrants
  • Germany – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn
  • Australia – Medical device incident reporting (MDIR) guide
  • Australia – TGA’s UDI Proposal Gets Broad Industry Support
  • International – Researchers develop ‘highly sensitive’ breast cancer blood test
  • UK – Screening test may prompt earlier ovarian cancer detection
  • Denmark – Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance
  • Europe – IMQ becomes fourth Notified Body designated to MDR
  • Europe – Gestion du rapport bénéfice/risque des dispositifs médicaux – Projet de norme PR XP S99-223
  • Europe – New IMDRF recommendations for Conformity Assessment Body recognition requirements
  • Singapore – Regulatory chart: Medical device & IVD registration in Singapore
  • Europe – DEKRA accredited under the MDR
  • UK – New MDR Conformity Assessment Routes guide
  • Switzerland – L’ON SUISSE QS ZÜRICH AG jette l’éponge
  • USA – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (Draft Guidance)
  • USA – US FDA finalizes post-market safety reporting guidance for combination products
  • USA – Examining US FDA criteria for medical device cybersecurity and risk management
  • USA – U.S. asks E.U. to delay MDR/IVDR by 3 years
  • A Wearable Device Is Changing the Way Clinicians Manage Parkinson’s Patients
  • Australia – Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?
  • UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario
  • Australia – Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)
  • China – US-China trade war unlikely to shift manufacturing to US
  • Australia – European implementation of Medical Device and IVD Regulations – Implications for Australia
  • Australia – Thermography should not be relied on for early detection of breast cancer
  • Brazil – Brazil’s ANVISA now requires electronic submissions of medical device FSCAs
  • Australia – Australian TGA finalizes medical device and IVD cybersecurity guidance
  • USA – Designing a Drug-Delivery Device? Read This First
  • USA – Bioabsorbable Materials 101
  • USA – FDA Finalizes Combo Product Postmarket Safety Reporting Guidance
  • USA – Bluetooth-enabled implant may be future of medication management
  • Australia – Cyber security for medical devices and IVDs
  • Australia – Breast implants and anaplastic large cell lymphoma
  • USA – Updated Fundamentals of US Regulatory Affairs Book
  • China – Chinese regulators preparing medical device UDI pilot
  • Europe – European Commission clarifies medical device vigilance requirements
  • Europe – State of flux: European Notified Body numbers decrease further ahead of MDR, IVDR
  • USA – 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design
  • UK – The Human Medicines and the Medical Devices Regulations 2019
  • Europe – Why Industry Anticipates a ‘Cliff-Edge’ Scenario With EU MDR/IVDR
  • USA – AdvaMed asks FDA to revise draft guidance on medtech inspections
  • Europe – Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
  • Europe – Call for applications: observers for the nomenclature sub-group of the medical device coordination group
  • UK – UL UK to Sunset Operations Under EU’s Medical Device Directive
  • UK – Device for preventing and relieving pain of cluster headaches approved by NICE in draft guidance
  • China – Chinese NMPA update: eRPS, predicate device data, technical review guidelines
  • France – Liste des DM génériques remboursable nécessitant un code d’identification individuel : démarche simplifiée
  • Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health
  • Spain – Spanish NB Applies for EU MDR Designation
  • USA – US FDA issues final rule for appealing medical device regulatory decisions
  • Europe – Medical Devices: Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
  • Europe – MDCG 2019-7 : Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’
  • South Korea – MFDS rolls out new regulation for IVD devices
  • Europe – EC Seeks Feedback on New and Revised MDR/IVDR Standards
  • Canada – Pre‐market Requirements for Medical Device Cybersecurity : Guidance Document
  • UK – New prostate cancer test could diagnose five years earlier
  • USA – US FDA shakes up Medical Device Reporting Program
  • USA – CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers
  • Maylasia – Process chart: Medical device & IVD registration requirements in Malaysia
  • UK – EU Exit preparedness
  • Europe – European Commission forecasts potential supply disruptions due to MDR, IVDR
  • USA – CDRH Drafts Clinical Recommendations for Prostate Tissue Ablation Devices
  • Australia – TGA Creates Guidance on Device Standards for Quality Management Systems
  • Europe – Notified Body Survey Offers New Data on EU Medical Device Certificates
  • Europe – European Commission Expert Panels on Medical Devices and In Vitro Diagnostic Devices
  • USA – FDA Releases 20 Years of Data on Medical Device Adverse Event Reports
  • UK – New implant recommended by NICE for uveitis
  • Australia – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019
  • Canada – Health Canada Consults on New Proposed Device Regulations
  • Europe – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’
  • Brazil – Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices
  • International – Real-World Data Collection – What Role Could Your Device Play?
  • Europe – EC Cautions on MDR/IVDR Impact on Device Availability
  • UK – LRQA winding down Notified Body services for Medical Devices and IVDs
  • USA – FDA Received 6,000 Reports About Essure in 2018
  • USA – CDRH Drafts Guidance on Mouse Embryo Assays
  • Europe – EC Selects Four UDI Issuing Entities
  • Japan – Japanese firm develops assay with integrated circuit for cancer detection
  • Europe – EU awards Active Implants a grant of around $6.8M
  • UK – UK NB Will Not Apply for EU MDR/IVDR
  • Europe – M2M Data Exchange Services Definition (v1 29 May 2019)
  • Europe – M2M data exchange services and entity models introduction (v1 29 May 2019)
  • Europe – Brexit sans accord: la Commission européenne fait le point sur les préparatifs avant le Conseil européen (article 50) de juin
  • China – China’s NMPA reports major decrease in medical device approvals
  • USA – 11 Medical Devices Recently Approved by FDA
  • Europe – Lignes directrices de NICE sur les meilleures pratiques avec le PICO[TM]
  • Europe – Nouvelle Version 1.22 du Manuel Produits Frontière est sortie
  • USA – The Best Predicate or the Worst?
  • USA – FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
  • Spain – Spain Introduces Portal for Electronic Reporting of Medical Device Adverse Events
  • Europe – MDCG 2019-6 : Requirements relating to notified bodies – Questions and answers
  • USA – NESTcc Taps Apple Watch as First Wearable Project
  • France – Carmat va reprendre la production de ses coeurs artificiels pour les essais cliniques
  • China – Chinese NMPA update: ePRS, predicate device data, technical review guidelines
  • Europe – EU MDR: Are Your Labels Compliant?
  • International – Roche launches first IVD test for detecting ROS1 protein in cancers
  • Europe – Spanish NB Bows Out Ahead of EU MDR
  • USA – GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements
  • Europe – Guidelines for Member States on the use of Data Exchange solutions
  • Europe – Eudamed Data Exchange Services and Entity Models Introduction
  • Europe – EU Device Industry Groups Call to Accelerate MDR Implementation
  • USA – NESTcc Advances Data Quality and Study Design Frameworks
  • China – China’s NMPA Strengthens Oversight of Imported Medicinal Materials
  • Europe – Le temps presse pour les fabricants de DM de classe I
  • USA – US FDA calls for test cases for its SaMD Pre-Cert Program
  • USA – Experts Discuss CDRH Proposals That May Require New Authorities
  • USA – FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
  • USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
  • USA – FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
  • USA – Developing a Wearable Display for Surgeons
  • USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming
  • Europe – May 2019 Regulatory Roundup: Europe on the verge of MDR
  • Europe – Changements significatifs dans le cadre de la période transitoire (article 120) : Guide GMED pour l’interprétation
  • USA – AI could spot lung cancer before radiologists
  • India – India Assigns Risk Categories to Imaging Scanners, Other Recategorized Devices
  • USA – FDA provides updates on postmarket safety review of Bayer’s Essure
  • Canada – Performance Standards for the Fees in Respect of Drugs and Medical Devices Order
  • Europe – Is Your Testing Program Ready for the EU MDRs?
  • Europe – Évaluation biologique des dispositifs médicaux — Partie 23 : Essais d’irritation PR NF EN ISO 10993-23 – Enquête Publique – Date de clôture : 05/07/2019
  • International – Connected medical device design for the Internet of Things
  • USA – Final FDA Q-Submission guidance includes medical device cybersecurity coverage
  • USA – FDA Finalizes Two Guidances to Align X-Ray Imaging Devices With International Standards
  • USA – FDA Finalizes Q-Submission Feedback and Meetings Guidance
  • USA – FDA to End Alternative Summary Reporting for Devices
  • Europe – EC Explains What UDI Information to Provide for Eudamed
  • USA – FDA Publishes List of Priority Patient Preference Areas for Medical Devices
  • UK – New NICE guideline to help spot suspected neurological conditions
  • Europe – Widespread Concern Over Europe’s Uncertain Regulatory Future Highlights Region’s Importance
  • Brazil – Spring 2019 medical device regulatory recap: Brazil
  • Canada – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing : Publication of the Guidance Document
  • Europe – Brexit update: Extension to October 31, 2019
  • International – IMDRF Takes Another Stab at IVDs, MDSAP
  • Switzerland – Swiss Medtech : L’incertitude juridique paralyse l’industrie de la technologie médicale
  • USA – FDA Drafts Guidance on Adjusting for Covariates in Randomized Trials
  • China – China Starts Clampdown on Unregistered Devices, Threatens Severe Punishments
  • USA – Could Secret Sales Bar Your Ability to Patent a Medical Device?
  • USA – There’s a New Weight-Loss Device in Town and TPS Is Its Name
  • USA – FDA permits marketing of first medical device for treatment of ADHD
  • Europe – TEAM-NB : Survey on NBs applications against IVD new regulation
  • Europe – TEAM-NB : Position Paper on Spinal Classification per the MDR
  • USA – CDRH Draft Guidance Tackles Nitinol Devices
  • USA – CDRH Drafts Guidance on Quantitative Imaging
  • Europe – Investigational site and personnel selection for medical device clinical studies
  • Europe – EU Device Coordination Group Offers Eudamed Guidance
  • Europe – RDM et RDMDIV : les fabricants dans l’attente des organismes notifiés
  • USA – Purified Fat Could Be an Alternative to Breast Implants
  • USA – FDA Removes 9% of Medical Device Registrations from Database
  • UK – Virtual manufacturing of medical devices
  • UK – ‘Use greener asthma inhalers’, encourages NICE
  • International – IMDRF Works to Speed Entry of Devices Across Multiple Countries
  • Europe – COCIR Pushes to Harmonize Device Standards
  • Europe – Comment protéger le logiciel d’exploitation d’un DM ?
  • USA – FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD
  • USA – FDA Proposes Radiological Health Deregulatory Action
  • UK – NICE backs PredictImmune’s IBD prognosis test
  • UK – BREXIT : où en est-on ?
  • UK – BREXIT : Fiches d’information et FAQ
  • USA – FDA Drafts Guidance on Inspections of Medical Device Establishments
  • Europe – GMDN Agency Welcomes Alignment of Medical Device Database to Global Nomenclature
  • USA – FDA Panel Recommends New Postmarket Requirements for Breast Implants
  • Europe – MDIVD : Get ready for the new regulation
  • Europe – EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates
  • Europe – EU MedTech Industry Signals Need for Harmonized Approach to Cybersecurity
  • China – Hong Kong Proposes Overhaul of Guidance on Medical Device Responsible Persons
  • Europe – European Panel Offers Advice on Complex Drug Trials
  • Europe – EU MDR/IVDR Coordination Group Urges Exemption Clarification
  • Europe – Rationalize Your Labeling Approach to Prepare for the EU MDRs
  • Europe – Dutch regulators weigh in on no-deal Brexit impact for medical device companies
  • UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices
  • Europe – Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)
  • USA – CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders
  • Europe – EUDAMED : Draft Functional specifications
  • Italy – Italian medical device nomenclature to be adapted for Eudamed database
  • USA – MDIC Works to Standardize Oversight of NGS-based Assays
  • USA – FDA proposes exempting some flow cytometers from 510(k) requirements
  • UK – Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal
  • Europe – EUDAMED – la nomenclature CND va remplacer celle du GMDN
  • USA – FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures
  • Brazil – Notification pathway for Class I devices nearing publication in Brazil
  • China – Chinese scientists develop nanogenerator for cancer drug delivery system
  • Europe – U.S. and EU Agree to Work Together on UDI Standards
  • India – Healthcare needs a unified regulator for drugs and devices, advise experts
  • USA – Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh
  • India – India to Treat Implants and Imaging Equipment as Drugs From April 2020
  • USA – Exemptions for Unclassified Devices: CDRH Updates Guidance
  • USA – Combo Product Reviews: FDA Drafts Guidance
  • Europe – Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer
  • USA – Medtronic Launches Mazor X Stealth Edition for Robotic-Assisted Spine Surgery
  • USA – Boston Sci’s BPH Treatment Effective in Preserving Sexual Function After 4 Years
  • USA – Integrated Device Design Critical to Rapid Medical IoT Development
  • USA – After the Product-Centric Medical Industry – What’s Next?
  • USA – CES 2019 : revue des technologies qui vont stimuler l’essor du numérique en santé
  • USA – Applied Tissue Technologies’ negative-pressure dressing gets FDA nod
  • Europe – Survey on NBs applications against IVD new regulation
  • International – 11 innovative medical devices you need to know from 2018
  • India – India’s health ministry accepts eIFU for medical devices
  • Europe – Is Progress on MDR and IVDR Happening Fast Enough?
  • Europe – Latest Brexit Agreement Voted Down by British Parliament
  • USA – FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices
  • UK – Brexit: 10 key changes to UK product safety laws?
  • Europe – Kheiron Medical launches trial of AI algorithm for breast cancer Dx
  • USA – Wearable dialysis system gains breakthrough designation from FDA
  • Europe – MDR & NBs – L’inquiétude grandit (The worry is growing)
  • Australia – Australia Explores Adopting UDI System
  • Australia – TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity
  • USA – What Will 2019 Bring for Medtech?
  • South Korea – S. Korean devicemaker debuts AI-based diagnostics platform
  • Europe – European Regulators Publish UDI Guidance
  • China – China FDA Reorganization: Impact for medical device registrants
  • USA – FDA Reclassifies Some ECT Devices
  • USA – FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices
  • USA – FDA Finalizes Rule to Simplify Medical Device Classification Procedures
  • UK – New NICE standards to improve digital health tech uptake
  • UK – PredictSURE IBD gains CE mark, set for UK and EU launch
  • UK – Scientists develop revolutionary tech to improve prostate cancer detection
  • USA – Benefits of ERP in an FDA-Regulated Environment
  • Europe – Evaluations conjointes des organismes notifiés dans le secteur des dispositifs médicaux : état des lieux
  • UK – Are Smaller Hip Implants in Older Patients More Cost Effective?
  • Europe – Déployer des dispositifs médicaux IoT en toute confiance
  • USA – First Device Cleared for the Prevention of Cluster Headache
  • Canada – Health Canada Proposes Changes to Priority Review Requests for Medical Devices
  • USA – Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators
  • USA – New steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
  • Europe – 7 Things That Have Medtech Companies Thankful in 2018
  • Europe – Is Progress on MDR and IVDR Happening Fast Enough?
  • Europe – BSI achieves Designation for its Netherlands Medical Devices Notified Body
  • Israel – How One Digital Health Company is Outsmarting Diabetes
  • USA – Benefits of ERP in an FDA-Regulated Environment
  • USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs
  • USA – Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating
  • USA – Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver
  • USA – Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years
  • USA – Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?
  • USA – Top 10 Medical Innovations for 2019
  • USA – UDI: 5 Opportunities You May Not Have Considered
  • International – Artificial Intelligence : the Future in Healthcare and Medical Device Manufacturing
  • Europe – EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes
  • USA – 7 electronic design problems that boost medical device costs
  • USA – Your device design looks great. Now how do you get reimbursement?
  • Europe – European Commission Offers Guidance on UDIs
  • USA – CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator
  • USA – Doctors to monitor hip, knee surgery patients using Apple Watch
  • Australia – Patient implant cards and consumer device information leaflets
  • USA – CDRH Drafts New Framework to Create a Pediatric Device Safety Network
  • USA – FDA Warns of Cyber Vulnerability in Medtronic Implantable Cardiac Devices
  • International – Body Vision Releases LungVision for Early-Stage Lung Cancer Diagnostics
  • USA – CDRH Works to Develop Proposed De Novo Regulation
  • USA – Eximo Medical’s Atherectomy Laser Cleared by FDA
  • USA – Self-Fitting Hearing Aid Receives Nod from FDA
  • UK – Roche CoaguChek device producing inaccurate results
  • Europe – The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across Europe.
  • USA – CDRH Offers Look at Upcoming Guidance Documents in FY 2019
  • Europe – Digital health projects win £17 million
  • USA – Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved
  • USA – Philips Unveils Augmented Infant Resuscitator for Safe Rescue of Asphyxiated Newborns
  • Europe – Effects of “No Deal” Brexit for Medical Device Sector
  • USA – FDA Reveals Vision for the Transition to ISO 13485
  • USA – Intuitive Surgical Could Help Usher in a New Era for Medtech
  • USA – Paladin Carotid PTA Balloon with Embolic Protection Filter Cleared by FDA
  • USA – FDA Clears Pure-Vu Slim Sleeve to Clean Out Colons Using Slim Colonoscopes
  • USA – Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance
  • UK – Notify MHRA about a clinical investigation for a medical device
  • USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps
  • USA – FDA Looks to Make FOIA Process Easier
  • Canada – Health Canada to Amend List of Recognized Standards for Medical Devices
  • Study – Modernizing the Medtech Supply Chain
  • USA – Microfluidic Device Corrals Viable Sperm for IVF
  • Canada – Veta Smart Case for Epinephrine Auto Injectors Now Available
  • USA – Masimo’s Tiny Breathing Sensor Cleared for Tiny Patients in U.S.
  • Europe – New Device Vibrates Skull to Diagnose Cause of Dizziness
  • UK – Versius Robotic Surgical System Unveiled by UK Company
  • USA – Two New Penumbra Catheters to Suck Out Stroke-Causing Clots
  • Europe – Electronic implant offers hope for preventing epileptic seizures
  • Europe – Europe Update: Notified Body MDD, AIMDD Timelines
  • Europe – Taking a Deeper Look at Device Certification and Recertification
  • Discovery – Eye Test to Detect Alzheimer’s Disease Before Symptoms Start
  • Discovery – Vagus Nerve Stimulation Highly Effective at Treating Drug Resistant Depression
  • USA – A Temporary Fix for the EpiPen Crisis?
  • Australia – Expands Range of Acceptable Foreign Regulators for Device Applications
  • Discovery – VistaTablet for Monitoring Patients’ Eight Vital Signs from Anywhere
  • Discovery – Building a Better Insulin Infusion System
  • USA – FDA Approves First Contraceptive Mobile App
  • Australia – TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance
  • Découverte – Recherches bibliographiques pour l’évaluation de la performance clinique
  • Category: International
    • Israel – New study use musical tests for early detection of cognitive decline
    • International – MDSAP policy for remote quality system audits to expire in September 2022
    • South Africa – South African regulators issue guidance for medical device imports, advertising
    • Saudi Arabia – Saudi FDA postpones Unique Device Identification compliance deadlines
    • International – Des valves cardiaques imprimées en 3D
    • International – IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback
    • International – Révision de la norme ISO 10993-17 : quelles évolutions ?
    • International – Le CES et la Banque mondiale mettent la santé des femmes à l’honneur
    • International – Regulators issue Good Machine Learning Practice guiding principles for AI/ML medical device development
    • International – Du matériel médical conçu pour l’homme blanc
    • International – Recommandation sur l’éthique de l’intelligence artificielle
    • International – FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice
    • Saudi Arabia – Saudi FDA extends deadlines for Unique Device Identification compliance
    • International – Eurasian Economic Union revises medical device registration system
    • International – Bandes ou bas de contention : Le doute subsiste
    • International – Covid-19 : quelle protéine virale les TROD doivent-ils cibler en sérologie pré-vaccinale ?
    • International – Hydrogel brain implant mimics brain tissue
    • International – Blood test monitors ACE2 protein in COVID-19 patients
    • Saudi Arabia – SFDA revises guidance on storing and transporting medical devices
    • International – La Norme ISO 9001 ne sera pas révisée
    • International – Use Errors Part 2: Estimating the severit