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- 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
- International – Audit MDSAP : le retour d’expérience d’un expert en affaires règlementaires
- 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 ?
- USA – FDA issues final guidance on devices containing animal-derived materials
- France – 32,3 jours : le délai d’attente pour une IRM urgente en 2018
- France – ANSM – Nominations : Décision n° 2018-216 du 28/09/2018
- Audio Tour App Detour Steers You Away from the Typical Tourist Traps
- Mathematica 10 released on Raspberry Pi
- I built an app that does triangulation of points on the earth
- Terraform – Cross PaaS configuration management?
- Scalable code without bloat: DCI, Use Cases, and You
- Bonjour tout le monde !
- Catégorie : Médicaments
- 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
- Europe – EMA starts rolling review of the Sputnik V COVID-19 vaccine
- 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
- Europe – EMA review of regdanvimab for COVID-19 to support national decisions on early use
- 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
- Europe – First oral treatment for spinal muscular atrophy (SMA) recommended for approval
- Europe – EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab)
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2021
- 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 – Regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2
- 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
- Europe – EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
- 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 – EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen
- 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
- Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
- UK – NICE rejects Lilly’s Verzenios for advanced breast cancer
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
- Europe – EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
- UK – NICE turns down bluebird bio’s gene therapy Zynteglo
- USA – Synairgen’s inhaled COVID-19 treatment included in US trial
- Europe – Clarification on Sputnik V vaccine in the EU approval process
- France – Médicament : les conditions de remboursement du Smecta vont se durcir
- Europe – Euro Roundup: NICE seeks feedback on how it develops health technology guidance
- Europe – EMA preparing guidance to tackle COVID-19 variants
- USA – FDA working on guidance to address coronavirus variants
- Europe – Type-IA variations: questions and answers
- Europe – Type-IB variations: questions and answers
- 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
- France – Comment relancer l’innovation Pharmaceutique en France ? par Frédéric BIZARD, Economiste
- 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
- Europe – EMA reviewing data on monoclonal antibody use for COVID-19
- 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 – COVID-19 vaccines: development, evaluation, approval and monitoring
- Europe – EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
- Europe – EMA : Good pharmacovigilance practices
- Europe – EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
- 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
- Europe – Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
- Europe – EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab)
- 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
- Europe – EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
- Europe – EMA : Clarification of Comirnaty dosage interval
- UK – NICE recommends Revlimid for newly diagnosed multiple myeloma patients
- 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
- USA – CDER issues list of draft guidances for release this year
- Mexico – Mexico wants more information before approving Sputnik V
- USA – Regeneron’s antibody cocktail prevents COVID-19 in high-risk patients
- USA – A look at FDA’s data on priority and competitive generics
- 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
- 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
- Europe – EMA : Human medicines – highlights of 2020
- 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
- Europe- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
- Europe – Cyberattack on EMA – Update
- 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: post-authorisation
- Europe – Treatments and vaccines for COVID-19: authorised medicines
- Europe – Treatments and vaccines for COVID-19: medicines under evaluation
- Europe – EMA : Treatments and vaccines for COVID-19: research and development
- 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 – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
- Europe – European Pharmacopoeia Commission adopts new general chapter Contaminant pyrrolizidine alkaloids (2.8.26)
- Europe – EMA : Extra dose from vials of Comirnaty COVID-19 vaccine
- 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 – Pharmeuropa 33.1 just released: don’t miss this opportunity to provide your comments
- 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
- Europe – EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU
- 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
- 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
- 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 : Data breach was limited to one IT application
- Europe – EMA organises a second public meeting about the new COVID-19 vaccines
- 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
- Europe – EMA recommends first COVID-19 vaccine for authorisation in the EU
- 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
- Europe – Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 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 – EMA Management Board: highlights of December 2020 meeting
- Europe – COVID-19 guidance: research and development
- Europe – COVID-19 guidance: assessment and marketing authorisation
- Europe – COVID-19 guidance: post-authorisation
- Europe – Euro Roundup
- UK – Guidance on MAH and QPPV location from 1 January 2021
- USA – FDA issues final guidance on controlled correspondence
- France – Le parcours de Christelle Ratignier-Carbonneil, nouvelle directrice générale de l’ANSM
- 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
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
- 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 – EMA : Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
- Europe – BREXIT : fin de la période de transition au 31 décembre 2020
- 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
- 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
- France – Le label « priorité nationale de recherche »
- 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
- Europe – EMA : Public-health advice during COVID-19 pandemic
- 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 – ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
- 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
- Europe – Chloroquine et hydroxochloroquine : risques de troubles psychiatriques selon le PRAC
- 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
- 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
- Australia – COVID-19 vaccines undergoing evaluation
- USA – FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
- Europe – EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
- Europe – Market survey: Data Access to an electronic health care record database from the United Kingdom
- Europe – EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
- Europe – EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
- 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
- France – La liste noire des 93 médicaments à éviter en 2021
- Europe – Questions and answers on labelling flexibilities for COVID19 vaccines
- Europe – Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
- 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
- Europe – Update on remdesivir – EMA will evaluate new data from Solidarity trial
- Europe – HMA/EMA statement on approval of vaccines
- 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
- Europe – EMA organises public meeting on COVID-19 vaccines
- USA – FDA issues 34 new and revised product-specific guidances
- Europe – EMA revises remote pharmacovigilance inspections guide
- India -India testing five COVID-19 vaccines
- France – Covid-19. Pfizer, Moderna, Sanofi : six questions pour s’y retrouver parmi ces vaccins prometteurs
- 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
- France – ANSM : Rapport d’activité 2019
- USA – FDA finalizes certificates of confidentiality guidance
- Europe – EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
- 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 – Evaluation of anticancer medicinal products in man
- 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 – EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
- Europe – Nitrosamines: EMA aligns recommendations for sartans with those for other medicines
- Europe – Meeting highlights from the CHMP 9-12 November 2020 : Five new medicines recommended for approval
- 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
- International – International regulators and WHO join forces to address COVID-19 challenges
- 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
- International – Vaccins contre la COVID-19 : un point sur les essais de phase III en cours
- 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 – COVID-19 vaccines: development, evaluation, approval and monitoring
- 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
- France – Covid-19 : L’Institut Pasteur développe un vaccin issu de celui de la rougeole
- USA – FDA revises REMS MAPP for new comparable ETASU provisions
- Europe – Extra transparency measures for COVID-19 vaccines and therapeutics
- 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
- Europe – PRAC reviews EMA guidance on risk management plan requirements for COVID-19 vaccines
- 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
- Europe – Regulatory update – EMA encourages companies to submit type I variations for 2020 by end of November
- 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
- Europe – Strengthening global collaboration on COVID-19 real-world evidence and observational studies
- UK – ICR urges change as NICE rejects Keytruda plus chemotherapy
- USA – FDA plans master protocols to monitor COVID vaccine safety, efficacy
- 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
- 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
- France – Servier se dote d’une direction « Digital, data et systèmes d’information »
- Europe – UPDATE : Metformin-containing medicines
- 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
- Europe – EMA : First long-acting injectable antiretroviral therapy for HIV recommended for approval
- Europe – CHMP recommended ten medicines for approval at its October 2020 meeting
- Europe – EMA : First treatment for rare condition primary hyperoxaluria type 1
- Europe – EMA : New gene therapy to treat rare genetic disorder metachromatic leukodystrophy
- Europe – EMA : First CAR-T cell medicine for mantle cell lymphoma
- 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
- France – L’expérimentation de l’usage médical du cannabis : Décret n° 2020-1230 du 7 octobre 2020
- 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
- France – Loi anti-cadeaux : nouvelles dispositions présentées par Simmons & Simmons
- Canada – Guidance : Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications
- Europe – EMA : IRIS new online platform for scientific advice
- 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 – EMA starts second rolling review of a COVID-19 vaccine
- 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 – Pharmacovigilance Risk Assessment Committee (PRAC) Highlights 28 September – 1 October 2020
- 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
- Europe – EMA starts first rolling review of a COVID-19 vaccine in the EU
- 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
- Europe – New : PRAC recommendations on signals and new product information wording
- France – ANSM : Lutényl/Lutéran et risque de méningiome
- 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
- Europe – How incidents with medicines are managed in the EU – a ten-year analysis
- 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
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020
- USA – FDA explains how to measure symptoms in COVID-19 trials
- France – L’Union européenne signe avec Sanofi-GSK un contrat de précommande de vaccins contre la Covid-19
- Europe – New oral treatment for moderate to severe atopic dermatitis
- Europe – New treatment for children with chronic kidney disease
- 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
- France – Mise en garde sur l’utilisation potentiellement dangereuse de médicaments chez des enfants atteints d’autisme
- USA – FDA releases temporary guidance on production operations
- UK – NICE backing for AZ’ Tagrisso
- International – AstraZeneca resumes trial of COVID-19 vaccine
- Europe – Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
- 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
- France – Un Guichet unique pour accompagner l’innovation
- 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
- 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
- UK – NICE no for Pierre Fabre’s Braftovi
- UK – Updated guidance on pharmacovigilance procedures
- Europe – PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
- 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 – 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 – 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
- Europe – EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19
- 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
- Europe – ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs – Q &A
- 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
- Europe – EMA’s governance during COVID-19 pandemic
- 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
- Europe – Post-authorisation : Grouping of Variations – Q & A
- 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
- France – Choix méthodologiques pour l’évaluation économique à la HAS
- 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 – Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden
- Europe – EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
- Europe – Authorised uses of cancer medicine Yondelis unchanged following review of new data
- Europe – First antibody-drug conjugate for multiple myeloma patients with limited treatment options
- 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
- Europe – COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
- 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
- Europe – Clarification on the acceptability of requests for revision of CEP applications
- Europe – EMA : Quality of water for pharmaceutical 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
- 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
- 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
- Europe – EMA finalises opinion on presence of nitrosamines in medicines
- International – International regulators align positions on 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 – Treatments and vaccines for COVID-19
- 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
- Europe – Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
- 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
- France – La relocalisation de la production de médicaments en cinq questions
- 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
- Europe – First COVID-19 treatment recommended for EU authorisation
- Europe – Emer Cooke nominated as new EMA Executive Director
- UK – NICE green light for Roche’s Rozlytrek
- USA – FDA gives Project Renewal update at AACR
- USA – FDA finalizes bacterial pneumonia drug development guidances
- Europe – Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
- 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
- France – ANSM et COVID-19 – Demandes de visas publicitaires de médicaments
- Europe – From laboratory to patient: the journey of a centrally authorised medicine
- USA – FDA: Follow CDC guidance for COVID-infected employees
- Europe – Academia developing medicines for rare diseases to receive free EMA scientific advice
- Europe – European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines
- 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
- Europe – International regulators stress value of safe and effective vaccines
- UK – Government authorises use of dexamethasone for COVID-19
- China – Sinovac reveals positive preliminary data for COVID-19 vaccine
- France – Venant juste d’être octroyée en France, l’AMM de Baclocur® (baclofène) est suspendue par le justice !
- 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
- Europe – Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
- 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
- Europe – EMA : Highlights of Management Board: June 2020 meeting
- 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
- Europe – EU actions to support availability of medicines during COVID-19 pandemic – update #7
- USA – FDA releases compliance program for CDER, CDRH-led combination product inspections
- Europe – EMA receives application for conditional authorisation of first COVID-19 treatment in the EU
- 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
- France – France Biotech annonce la création d’un nouveau groupe de travail dédié au « Market Access » des sociétés innovantes en santé
- 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
- Europe – New vaccine for prevention of Ebola virus disease recommended for approval in the European Union
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
- Canada – Health Canada releases guidance to streamline COVID-19 clinical trials
- Europe – Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
- Europe – European medicines regulatory network fully mobilised in fight against COVID-19
- Europe – European Medicines Regulatory Network COVID-19 Business Continuity Plan
- Europe – Prospective dialogue between developers and regulators makes for better evidence generation
- Europe – Qualification of digital technology-based methodologies to support approval of medicinal products (Questions and Answers)
- Europe – EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines
- 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
- Europe – EMA calls for high-quality observational research in context of COVID-19
- 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 – Global regulators commit to cooperate on observational research in the context of COVID-19
- 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 – Pre-authorisation guidance
- Europe – European Pharmacopoeia welcomes Mexico as observer state
- UK – New COVID-10 guidelines for CKD and interstitial lung disease
- Europe – Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
- 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
- Europe – International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
- Europe – Update of EU recommendations for 2020/2021 seasonal flu vaccine composition
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020
- France – HAS : KEYTRUDA – Cancer bronchique non à petites cellules 1ere ligne
- 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
- Europe – Pharmacopée européenne 10e Edition, suppléments 10.3-10.5 – Nouvel abonnement ouvert à la vente !
- USA – COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- Europe – EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
- 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 – Big Data : Update
- 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 – Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
- Europe – Oxygen 98%: Ph. Eur. requests feedback on new oxygen quality to boost availability
- Europe – Guideline on Good Pharmacovigilance practices (GVP) : Module Vll – UPDATE
- Europe – COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
- International – ICH Q3C (R6) Residual solvents
- 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 – EMA starts rolling review of remdesivir for COVID-19
- Europe – EMA : Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
- 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
- Europe – Pharmacovigilance inspection procedures: human
- 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
- Europe – International regulators pledge collective support to combat COVID-19 pandemic
- UK – NICE u-turn backs Stelara for UC
- Europe – EU actions to support availability of medicines during COVID-19 pandemic – update #3
- 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
- Europe – COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine
- 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 – Update to guidance on regulatory expectations in the context of COVID-19 pandemic
- Europe – Procedural guidance during COVID-19 pandemic
- Europe – Submission deadlines for orphan designations
- USA – Guidance : S9 Nonclinical Evaluation for Anticancer Pharmaceuticals–Questions and Answers
- Europe – EMA’s governance during COVID-19 pandemic
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 April 2020
- Europe – Treatments and vaccines for COVID-19
- Europe – Public-health advice during COVID-19 pandemic
- Europe – Availability of medicines 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)
- Europe – Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data
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- 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 – Update : GCP – requirements for the qualification and validation of computerised systems used for managing clinical trial data
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- 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
- Europe – Guidance on regulatory requirements in the context of the COVID-19 pandemic
- Europe – Update on EU actions to support availability of medicines during COVID-19 pandemic
- 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
- France – COVID-19 et médicaments importés : attention au risque d’erreurs médicamenteuses
- Europe – EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
- Europe – Global regulators stress need for robust evidence on COVID-19 treatments
- 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
- Europe – EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
- 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
- Europe – EMA provides recommendations on compassionate use of remdesivir for COVID-19
- 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 – EMA : COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
- Europe – EMA : Explanatory note on general fees payable
- 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 – Update on treatments and vaccines against COVID-19 under development
- 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 to issue electronic certificates for medicines
- 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
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) March 2020
- 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 – Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
- 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
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- Europe – Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
- Europe – EudraVigilance – Inclusion/exclusion criteria for the ‘Important medical events’ list
- Europe – EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
- 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
- France – Médicament en tension ou rupture de stock
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee
- USA – Competitive Generic Therapies Guidance for Industry
- Europe – COVID-19: developers of medicines or vaccines to benefit from free scientific advice
- 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 – Le microbiote intestinal, une source de traitements contre le diabète
- 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)
- Europe – ICH Q12 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
- Europe – Update on nitrosamines in EU medicines
- 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
- Europe – EMA organisational changes come into effect
- USA – Guidance Snapshot Pilot
- Europe – Meeting highlights from the CHMP 24-27 February 2020
- 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 – EU ISO for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting
- 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
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- 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 – ICH E9 statistical principles for clinical trials
- Europe – Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation
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- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee : 10-13 February 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
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- Asia – Asia Regulatory Roundup
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- 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
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- USA – Biologic and Biosimilar Misinformation: FDA Drafts Guidance
- Europe – CHMP : Fifteen new medicines recommended for approval
- 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
- UK – UK withdrawal from the EU on 31 January 2020
- 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)
- France – Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance
- 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
- UK – Brexit Withdrawal Signed Ahead of UK’s 31 January Departure
- USA – Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
- UK – Tagrisso hit with NICE rejection for NSCLC
- USA – In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions
- USA – Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions
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- USA – FDA kicks off 3rd phase of OND restructuring
- Europe – EU Court of Justice Rules in Favor of EMA in Transparency Case
- USA – FDA to launch Drug Risk Management Board this month
- 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
- Europe – PRAC confirms four-week limit for use of high-strength estradiol creams
- 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
- Europe – Mandatory use of international standard for the reporting of side effects to improve safety of medicines
- UK – NICE rejects Keytruda, asks for more info
- Europe – Bientôt en ligne : nouveau site Pharmeuropa
- 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
- Europe – Pharmeuropa 32.1 just released
- 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
- Luxembourg – Création d’une « Agence luxembourgeoise des médicaments et des produits de santé » (ALMPS)
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- France – Prorogation de l’accord-cadre entre le Leem et le Comité économique des produits de santé
- Europe – Révision du chapitre général 5.8 sur l’harmonisation des pharmacopées
- USA – FDA Drafts Guidance on Demonstrating Substantial Evidence of Effectiveness
- Europe – Signal management
- USA – Bridging for Drug-Device and Biologic-Device Combination Products
- 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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- Europe – Launch of international pilot programme on inspection of manufacturers of sterile medicines
- Europe – 4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system
- 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 – Detection of N-nitrosamine impurities: the Ph. Eur. launches a public consultation on the revised general monograph Substances for pharmaceutical use (2034)
- 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 – Six-year review shows success of the EU signal management system in improving safe use of medicines
- Europe – Guidelines on good pharmacovigilance practices (GVP)
- Europe – How will pharmacovigilance look in 2030?
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- South Korea – Samsung executives found guilty of destroying evidence in fraud case
- 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
- USA – Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids
- 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
- UK – New ‘smart pill’ technology reports 100% success rate
- 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 – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – Novembre 2019
- 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
- France – L’Assemblée Nationale adopte un amendement historique sur la transparence
- UK – Mavenclad granted accelerated access by NICE
- Europe – PRAC recommendations on signals : 28-31 October 2019 meeting
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- 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
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- 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
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- USA – Labeling for Biosimilar Products
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- Europe – Dutch authorities hand over final building to EMA in Amsterdam
- Europe – EMA : Mid-year report 2019
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- UK – NICE ‘OK’ for Sativex in MS
- Europe – IRIS guide to the Industry portal
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- Europe – Consultation publique de la Pharmacopée Européenne sur le chapitre général 2.4.20. Dosage des impuretés élémentaires
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- UK – NICE recommends Elmiron for bladder pain syndrome
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- 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
- International – Tripartite meeting held between the EMA, FDA and PMDA to discuss regulatory approaches for the evaluation of antibacterial agents
- 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)
- USA – FDA has little authority to control quality of foreign-made APIs
- 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
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019
- USA – Drug Shortages: Root Causes and Potential Solutions
- Europe – EudraVigilance registration documents for Production
- Europe – Electronic registration process in EudraVigilance XCOMP : registration phases I, II and III
- USA – Determining the Clinical Benefit of Treatment Beyond Progression with Immune Checkpoint Inhibitors
- USA – Supporting Drug Development Through Physiologically Based Pharmacokinetic Modeling
- Europe – Brexit-related guidance for companies
- Europe – EudraVigilance Release Notes v.1.21
- USA – Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics
- Europe – ICH guideline E19 on optimisation of safety data collection – Step 2b
- International – ICH M10 on bioanalytical method validation
- USA – FDA Task Force Recommends Rating System for Drug Manufacturing Quality
- USA – Evaluating the Potential of Microengineered Human Cellular Systems to Predict Drug Effects in the Clinic
- 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
- Europe – EMA encourages companies to submit type I variations for 2019 by end of November 2019 : Regulatory update
- USA – Guidance : Providing Regulatory Submissions in Electronic Format – IND Safety Reports
- Europe – PRAC recommendations on signals
- Europe – EMA outlines process for nitrosamine impurity testing
- 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
- China – Dialogue with Chinese authorities on medicine regulation
- 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
- France – ATU – Autorisations temporaires d’utilisation
- 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)
- UK – Comparator products in Bioequivalence/Therapeutic Equivalence studies after Brexit
- Europe – Requesting and receiving EMA certificates through urgent and standard procedure from November 2019 to January 2020 : Notification
- USA – Newly Added Guidance Documents
- Europe – Enhancing consistency in wording of therapeutic indications to support healthcare decision-making
- USA – MCM-Related Guidance by Date
- 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 »
- Europe – First non-injectable treatment for severe low blood sugar levels
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- 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
- Europe – United Kingdom’s withdrawal from the European Union (‘Brexit’ Update)
- USA – FDA Unveils New Tables for Submitting Bioanalytical Methods
- Europe – Clinical Trial Regulation : Update
- Europe – PRAC : Four-week limit for use of high-strength estradiol creams
- 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
- Europe – Procedure for orphan medicinal product designation
- Europe – How to ensure that novel analytic methods are fit for decision-making
- USA – Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
- USA – Generic Drugs Guidances & Reports
- Europe – Delays in treatment of requests for revision and renewal of CEPs
- 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
- France – Bordeaux : médicaments commercialisés sans autorisation, un pôle de recherche scientifique dans le collimateur
- France – Nouvelle décision de police sanitaire à l’encontre du « Fonds Josefa » du Pr Fourtillan
- 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
- EMA -Change of name of liposomal medicines at high risk of medication errors
- Europe – EMA EudraVigilance Registration Manual
- UK – NICE delivers final ‘no’ for Novartis’ migraine treatment Aimovig
- Europe – EMA advises companies on steps to take to avoid nitrosamines in human medicines
- 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
- France – Médicaments : les laboratoires bientôt sanctionnés en cas de pénurie
- 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
- USA – FDA Drug Competition Action Plan
- 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
- UK – Businesses supplying medicines and medical devices: preparing for Brexit
- France – Un essai clinique mené sans autorisation chez des patients atteints des maladies de Parkinson et d’Alzheimer interdit par l’ANSM
- France – Mediator Ouverture d’un Procès Hors Norme
- 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 – Data submission on authorised medicines (Article 57)
- Europe – EMA to provide guidance on avoiding nitrosamines in human medicines
- Europe – EMA to review ranitidine medicines following detection of NDMA
- 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 – Novartis Inhaler is First Device to be Certified Under MDR
- 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
- 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
- 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
- Europe – Paediatric investigation plans: questions and answers
- 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
- Pharma’s development races are heating up
- China – Novartis plans to submit 50 new drug applications in China by 2023
- 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?
- Europe – Quality data packages in early access approaches : workshop report published
- Europe – Names of liposomal medicines to be changed to avoid medication errors
- France – L’ANSM a constitué ses nouveaux comités scientifiques permanents – Point d’Information
- Europe – EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020
- 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 – First ‘histology-independent’ treatment for solid tumours with a specific gene mutation
- Europe – European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
- Europe – 25 July 2019 batch release
- Russia – Compliance with Russia’s « most complex » track and trace requirements given a boost
- International – Needle free: Erase wrinkles without injection
- 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
- Europe – EMA takes note of the European Ombudsman’s decision on pre-submission activities
- UK – MHRA launches consultation on how to best engage patients and the public
- USA – FDA Discusses RWD, RWE With Industry, Academia
- 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
- USA – What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains
- 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
- Europe – Pharmeuropa 31.3 just released
- 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
- 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 !
- 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
- France – Parution du nouveau Guide Pharma
- 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
- Europe – Call for all sponsors to publish clinical trial results in EU database
- France – HAS : « Choix méthodologiques pour l’évaluation de l’efficience à la HAS – Guide méthodologique
- 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 – One additional country to benefit from EU-US mutual recognition agreement for inspections
- 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
- France – Androcur et ses génériques (Acétate de cyprotérone) et risque de méningiome : Résultats de l’enquête de pharmacovigilance
- 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
- USA – Drugmakers Call for Changes to FDA Bioavailability Guidance
- 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
- Tout ce qu’il faut savoir sur les Biosimilaires – Interview du Pr Jean-Hugues Trouvin par Yves Tillet
- USA – FDA : Statement on a new effort to improve transparency and predictability for generic drug applicants
- France – La transplantation de microbiote fécal
- 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
- Europe – United Kingdom’s withdrawal from the European Union (‘Brexit’)
- Europe – Brexit-related guidance for companies
- Europe – Clinical Trial Regulation
- 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
- France – Levothyrox et médicaments à base de lévothyroxine : Rapport final
- France – Point de situation sur la disponibilité des corticoïdes en France – Point d’Information
- 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
- Europe – Two additional countries to benefit from EU-US mutual recognition agreement for inspections
- 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
- Europe – Bientôt disponible : La Pharmacopée Européenne (Ph. Eur.) 10e Edition
- 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 – Consultation on draft guideline on quality requirements for medical devices in combination products
- France – La prophylaxie pré-exposition (PrEP) au VIH par ténofovir disoproxil/emtricitabine (TRUVADA® et ses génériques)
- 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
- France – Seule une refondation de la politique du médicament permettra de retrouver une industrie pharmaceutique compétitive
- 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
- Europe – EMA facilitates early engagement with medicine developers to combat antimicrobial resistance
- 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
- France – ANSM : Cannabis à visée thérapeutique en France : Les experts poursuivent leurs travaux sur les modalités de mise à disposition
- 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
- 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 »
- Europe – EMA annual report 2018 published
- 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 – MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- France – ANSM : Venclyxto (vénétoclax) : signal de sécurité issu de l’essai clinique évaluant le vénétoclax dans le traitement du myélome multiple – Point d’Information
- USA – Drugmakers, EMA Comment on FDA Guidance on Assessing Food Effects on Drugs
- USA – FDA accused of failing to act on Parkinson’s drug dangers
- 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
- Europe – EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo
- USA – FDA Drafts Guidance on Adjusting for Covariates in Randomized Trials
- France – Antiépileptiques au cours de la grossesse : Etat actuel des connaissances sur les risques de malformations et de troubles neuro-développementaux
- USA – FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products
- USA – FDA : New steps to strengthen the process of initiating voluntary recalls
- 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
- USA – Bispecific Antibodies: FDA Drafts Guidance for Developers
- France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves – Point d’Information
- UK – NICE final guidance published for Cimzia
- Europe – Pharmaceuticals: EU refines intellectual property rules
- Europe – Registered substances mapped for regulatory action
- Canada – Health Canada Opens Generic Drug Guidances for Consultation
- UK – Akcea steals march on Alnylam with NICE approval
- Europe – Update of EU recommendations for 2019/2020 seasonal flu vaccine composition
- Europe – European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit
- Europe – EMA Enters Into Information-Sharing Agreement With EU Quality Body
- Switzerland – Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans
- USA – FDA Expands RWE Demonstration Project
- France – ANSM : Répertoire des médicaments génériques -Avril 2019
- France – Indemnisation record pour les malades du Mediator
- Europe – Préparation à un Brexit sans accord: la Commission européenne dresse le bilan des préparatifs et fournit des orientations pratiques pour garantir une approche coordonnée au niveau de l’UE
- UK – Novartis’ Kisqali hit with NICE rejection
- UK – UK requests another Brexit deadline extension, furthering market uncertainties
- USA – FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
- UK – MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates
- France – LEVOTHYROX : la nouvelle étude annoncée par la presse n’est qu’un article d’opinion
- 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
- USA – Patient Groups, Industry Seek Changes to Rare Disease Drug Guidance
- France – Levothyrox : les deux formules du médicament ne seraient pas substituables, selon une étude
- UK – MHRA Offers Additional No-Deal Brexit Guidance
- Canada – Release of ICH E6(R2): Good Clinical Practice – Notice
- Europe – Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines
- Australia – TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals
- Europe – First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)
- USA – Gottlieb signs off with flair – and pledge of further drug price commentary
- USA – FDA Begins Plotting Pathway for Cannabis Product Approvals
- France – Lipidots : des cargos moléculaires pour la délivrance de médicaments
- USA – FDA releases new digital health rules for pharma companies
- USA – Revocation of the Test for Mycoplasma
- UK – NICE nod for Lilly’s breast cancer drug Verzenio via CDF
- Europe – EU recommendations for 2019/2020 seasonal flu vaccine composition
- Europe – Regulatory information – 1.7% increase of fees from 1 April 2019
- Australia – Guidance for TGO 101
- UK – BREXIT : où en est-on ?
- Europe – BREXIT : Fiches d’information et FAQ
- Europe – New gene therapy to treat rare inherited blood condition
- Europe – Symposium EDQM-USP : les différentes utilisations des étalons de référence de pharmacopée
- Europe – New EudraVigilance system improves reporting of side effects and detection of safety signals
- Europe – Scientists Gene-Edited Tequila Bacteria to Make Cannabinoids
- UK – NICE green light for Imfinzi in groundbreaking early lung cancer treatment
- Europe – 20 years of sampling & testing programme for medicines authorised for the EU
- 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
- Europe – Brexit-related guidance for companies
- USA – CBER Finalizes Guidance on Use of Standards in Regulatory Submissions
- India – Indian regulators waive clinical trials for drugs approved elsewhere
- UK – NICE recommendation for Steglatro in type II diabetes
- Europe – HSCT Remains Standard in Childhood ALL, Despite CAR T-Cells
- Europe – European Panel Offers Advice on Complex Drug Trials
- USA – NCCN: Updated NSCLC Guidelines Hone in on PD-L1 Testing
- 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
- Europe – EMA Management Board: highlights of March 2019 meeting
- USA – FDA’s OCP Works to Modernize Review Functions
- USA – Applying human factors to nicotine replacement therapy drug products
- UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices
- USA – FDA Finalizes Two Guidances on HIV Drug Development
- Australia – Australian manufacturing licences and overseas GMP certification
- 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 – FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders
- Canada – Health Canada Begins Release of Clinical Data on Drugs and Devices
- USA – Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance
- 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
- Australia – Updated GMP licence application e-forms
- UK – Completed Paediatric Studies – submission, processing and assessment in the event of a no deal scenario
- USA – FDA approves a new generic valsartan
- USA – FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility
- UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal
- China – China may launch trials on new gene-editing technology within 2 years
- France – Nouvelle mesure d’accès à l’innovation : ATU de cohorte d’extension d’indication pour l’utilisation de Lynparza dans certains cancers gynécologiques
- 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 – Gottlieb to Resign as FDA Commissioner
- Europe – Adjusted fees for applications to EMA from 1 April 2019 – Regulatory information
- USA – New Impurity Found in Blood Pressure Drug Prompts Expanded FDA Recall
- France – Gardasil 9: Les françaises plus résistantes que les américaines?
- France – Le déremboursement entraîne une hausse immédiate des ventes des médicaments non remboursables
- 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 – New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
- Europe – CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease
- Europe – First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban
- Europe – First treatment for rare disease characterised by high levels of triglycerides in blood
- Europe – New add-on treatment for patients with severe asthma
- 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
- Europe – First guidance for managing Drug/Device combination
- Europe – Elemental impurities reference standards: leaflets now include expanded uncertainty
- Europe – The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8.
- USA – Continuous Manufacturing: FDA Drafts Quality Guidance
- Europe – Procedural update on submission of Type I variations to EMA in March, April and May 2019
- India – India Advances Plan to Create Mobile Drug Testing Laboratories
- UK – Roche Wins Approval for Perjeta in Breast Cancer Subgroup
- France – Maladies rares : l’Inserm coordonne un programme européen d’ampleur inégalée
- USA – Generic Drugs: FDA Releases 74 Product-Specific Guidances
- USA – FDA Defends its Efforts to Ensure Generic Drug Quality
- France – « Pharma Papers ». Produire des médicaments « équitables », efficaces et au juste prix : les Pays-Bas l’ont fait
- France – OPIOÏDES : augmentation des décès, des intoxications et du mésusage selon l’ANSM
- Europe – Les eaux à usage pharmaceutique : principes de production et critères de la Ph. Eur.
- USA – FDA Offers Guidance on Nicotine Replacement Therapies
- 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
- Europe – EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database
- 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 – ‘Inflexible’ NICE blocking access to rare disease drugs
- France – Le Cabinet WHITE-TILLET recrute un consultant, docteur en pharmacie ou ingénieur
- UK – Report finds NICE’s routine appraisals need reform
- India – Indian regulators tweak drug trial rules
- France – Clinical trials on medicinal products submitted to the ANSM as part of the FastTrack procedure
- 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
- USA – Competitive Generic Therapy Designations: FDA Explains Process in New Draft Guidance
- China – China plans to reduce VAT for rare disease therapies
- UK – Advertise your medicines
- Europe – Role of big data for evaluation and supervision of medicines in the EU
- UK – Alunbrig recommended by NICE for non-small-cell lung cancer
- UK – NICE changes its mind on Perjeta
- UK – Novartis first to benefit from NICE advice on ‘patient preference’
- USA – Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds
- Europe – Initiative citoyenne européenne: la Commission enregistre l’initiative «Let’s demand smarter vaping regulation!»
- UK – New NICE guidelines on antibiotic prescribing for pneumonia
- UK – New ‘Trojan horse’ cancer treatment shows early promise
- Europe – EMA : New online platform for parallel distribution
- 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
- USA – Regulatory Intelligence, Risk Management and Drug Promotion
- 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
- Europe – Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
- Europe – First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
- 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
- Europe – European Commission Consults on Orphan Drug Applications
- France – REVUE PRESCRIRE : LA LISTE NOIRE DES 68 MÉDICAMENTS DANGEREUX
- USA – Marketing Status Notifications: FDA Drafts Guidance
- Europe – UK and Russia sign MoU on Regulatory Cooperation on Medicines
- USA – FDA Pushes Back eCTD Deadline for Type III DMFs Again
- Europe – European Commission Focuses New Report on Pharma Competition Enforcement
- Europe – European Commission Updates Q&A on Safety Features for Medicinal Products
- Europe – Novartis urges government to ‘minimise disruption’ in no-deal Brexit
- USA – FDA Takes Steps to Address Root Causes of Sartan Safety Issues
- UK – UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit
- USA – FDA Issues Draft Guidance on Tentatively Approved ANDAs
- Europe – Ph.Eur. Supplement 9.8 available now
- USA – Assessing the Effectiveness of REMS: FDA Drafts Two New Guidances
- Europe – Shire Raises ‘Substantial Concerns’ About ICH Guidelines in Feedback to EMA
- USA – Immunogenicity Testing: FDA Finalizes Guidance on Assay Development and Validation
- 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
- Europe – EMA relocation updates
- 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 – Brexit No-deal: MHRA Looks to Ease Grandfathering of Centrally Authorized Products
- UK – Trivalent gets UK green light for flu in over 65s
- Europe – EU Advances SPC Waiver Proposal
- France – Génériques. L’association Gemme présente des résultats 2018 jugés moroses
- France – Pénurie de vaccins et de médicaments : Les inquiétudes de France Assos Santé confirmées par une enquête exclusive
- 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
- USA – FDA to beef up cell and gene therapy staff
- France – L’année 2019, une année cruciale pour la loi « anti-cadeaux » !
- Europe – Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing
- Europe – Regulatory Science to 2025
- 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
- Europe – Revised guideline aims to strengthen global approach to development of new antibacterial medicines
- 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
- France – Cancer du système lymphatique : deux nouveaux traitements s’affichent à plus de 300 000 euros
- UK – Good pharmacovigilance practice
- UK – NICE says Novartis’ migraine drug Aimovig too costly for NHS
- Canada – Bipartisan Bill would allow Drug Imports from Canada
- 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 – Principe des 3R : avancées de la Commission européenne de Pharmacopée ces dix dernières années
- USA – CDER Outlines Drug Safety Priorities
- 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
- Europe – ‘Certification of Suitability to the monographs of the Eur Ph’ : Revised EDQM Guidelines
- Europe – EDQM revised guideline on Content of the dossier for chemical purity and microbiological quality
- USA – Drug Sponsors Urge FDA to Think Bigger About Master Protocols
- UK – NICE approves Xeljanz for Ulcerative Colitis
- UK – Drug pricing is pharma’s top concern in 2019
- UK – AstraZeneca wins NICE backing for asthma injection
- Europe – Human medicines: highlights of 2018
- UK – MHRA responds to consultation on Brexit no-deal proposals
- USA – FDA updates endpoint guidance for cancer trials
- USA – FDA helps to lead fight against antimicrobial resistance
- France – Novartis to buy France’s CellforCure to boost cell, gene therapy
- USA – Aorta Tears With Certain Antibiotic Use, FDA Warns
- 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
- USA – Warren Seeks to Create Government-Run Generic Drug Manufacturer
- 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
- Europe – Omega-3 Meds Not Effective After MI, EMA Panel Concludes
- 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
- Europe – Procédure de « Certification de Conformité aux monographies de la Pharmacopée européenne » – révision de certaines lignes directrices
- 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 – Gottlieb: New FDA policies could pave way for interchangeable insulin
- USA – Biomarker Qualification: FDA Drafts Guidance
- USA – Definition of the Term “Biological Product”
- UK – NICE says no to rival Alnylam and Akcea amyliodsis drugs – but deal could be done
- Europe – Nouvelle ligne directrice de l’EDQM « Comment lire un CEP »
- New Zealand – New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections
- China – China publishes 38 punishments for IP fraud, theft
- USA – FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics
- Europe – Major 3Rs achievement for Official Control Authority Batch Release of human vaccines
- USA – New efforts to assure the quality of compounded drugs
- UK – Pharma calls for more detail on plan for post Brexit meds access
- UK – NICE turns down Opdivo/Yervoy combo for kidney cancer
- Canada – Premarket Device Cybersecurity: Health Canada Issues Draft Guidance
- 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
- Europe – Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal
- UK – NICE backs Cimzia for psoriasis, but rejects Ilumetri
- USA – FDA Issues Draft Guidance on NASH Drug Development
- USA – Biosimilars Forum Calls for FDA Guidance to Address Misinformation
- USA – Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances
- Europe – EDQM laboratory: new NMR accreditation strengthens characterisation capacity for reference standards
- Europe – Update on the review of CEP applications for sartans
- Europe – Ph. Eur. Section 3. Materials and containers: clarification of legal status
- USA – FDA Finalizes Guidance on Post-CRL Meetings With ANDA Applicants
- France – Le CNOP dévoile trois rapports sur la prévention, les nouvelles technologies et la pharmacie clinique
- France – Le médicament Levothyrox au cœur d’un procès hors norme
- 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
- USA – GAO Raises Questions on FDA’s Orphan Drug Designation Process
- France – Nouveau rappel de médicaments à base de valsartan
- Europe – Revised guideline to assess risk of human medicines for the environment
- Europe – Data from patient registries to replace clinical trials in previously untreated haemophilia patients
- UK – NICE u-turn on Opdivo for skin cancer recurrence
- International – How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?
- France – Les Prescriptions médicamenteuses hors AMM en France : une clarification indispensable
- UK – Bayer’s Stivarga wins NICE backing for advanced liver cancer
- USA – New Product-Specific Guidances Focus on Drugs Without Generic Competition
- Europe – European Commission Revises Q&A on Safety Features for Medicinal Products
- Europe – Reflection paper on the qualification of non-genotoxic impurities
- France – Médicaments : rapport sur le progrès thérapeutique, édition 2018
- France – Baromètre Ipsos/Leem 2018 du médicament
- USA – Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages
- UK – NICE lung cancer backing for Keytruda is biggest expansion yet
- International – ‘Reprogrammed’ stem cells implanted into patient with Parkinson’s disease
- Europe – Révision du Guideline relatif à la Révision ou au Renouvellement de CEP : version corrigée disponible
- USA – FDA Works to Reduce Dog Testing in Drug Development
- Europe – Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
- 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
- France – ATU – Autorisations temporaires d’utilisation
- Europe – Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics
- Europe – CHMP recommends first oral-only treatment for sleeping sickness
- France – ALCOOL : LE BACLOFÈNE OBTIENT SON AMM
- Europe – Guideline on the quality of water for pharmaceutical use
- France – Les « Pharma Papers » : tout ce que les labos pharmaceutiques voudraient vous cacher
- France – Homéopathie : 74 % des Français veulent le maintien du remboursement
- France – Hépatite C. Le laboratoire Gilead baisse le prix de ses coûteux traitements de 20 %
- UK – NICE issues final draft guidelines for Novartis’ Kymriah
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
- 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
- France – Renouvellement de la commission de la transparence de la HAS
- France – Faut-il lyncher les médecins payés par les laboratoires pharmaceutiques ?
- USA – FDA Drafts Guidance on Using Metastasis-Free Survival Endpoints in Prostate Cancer Posted 13 November 2018 | By Ana Mulero
- Europe – EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision
- Japan – Stem cell-based Parkinson’s therapy tested in Japan
- USA – New drug options, risk factors added to U.S. heart guidelines
- France – MÉDICAMENTS en LIGNE : Les conditions d’une automédication en toute sécurité
- France – L’ANSM met en place un dispositif accéléré d’autorisation d’essais cliniques (Fast Track)
- Europe – WORKING WITH STAKEHOLDERS TO IMPROVE AVAILABILITY OF MEDICINES IN THE EU
- USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program
- Europe – EMA Issues Guideline on GVP Considerations for Pediatric Populations
- 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 – FDA Finalizes Guidance on Developing Fixed Combination Hypertension Drugs
- USA – Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance
- China – China Creates Guidance to Fast Track Important Drugs Approved Overseas
- France – L’ancienne formule du Levothyrox sera bien disponible en 2019
- 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
- USA – U.S. FDA Approves TherapeuticsMD’s Menopause Drug
- UK – AbbVie’s Venclyxto hit with NICE rejection
- France – Loi n° 2018-892 du 17 octobre 2018 relative à la désignation aléatoire des comités de protection des personnes
- UK – AbbVie’s Venclyxto hit with NICE rejection
- UK – NICE turns down hyperkalaemia therapies
- France – Un médicament fait ses preuves contre le cancer du sein hormonodépendant
- USA – FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline
- France – Médicaments : d’inquiétantes ruptures de stock
- USA – FDA warns 465 websites selling unapproved opioids, drugs for cancer, HIV
- 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
- Immunotherapy improves survival in patients with metastatic breast cancer
- USA – FDA committee to discuss CV trials for diabetes drugs
- International – Immuno-Oncology: What’s Next for Pharma?
- France – Plainte d’Anticor contre des experts du cholestérol
- UK – NICE rejects Lilly’s breast cancer drug Verzenios
- USA – FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH
- Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018
- USA – La FDA (Food and Drug Administration) approuve la première pilule numérique
- France – Plateforme de signalement des effets indésirables : un premier bilan
- UK – NHS set to save £150 million by switching to new versions of most costly drug
- France – Un référentiel pour justifier le « non substituable » ? Médecins et pharmaciens craignent une usine à gaz
- France – L’agence du médicament lance un dispositif accéléré d’autorisation d’essais cliniques
- USA – Oncologists’ Off-Label Prescribing Pits Access Against Reimbursement
- Europe – EMA Scales Back Medium-Priority Activities as Brexit Bites
- USA – FDA issues draft guidance to enhance efficiency in drug development
- France – La commission de la transparence précise et adapte ses principes d’évaluation des médicaments
- USA – Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence
- UK – UK Expands Access to Medical Cannabis
- USA – FDA Sets Record for Number of Generic Drug Approvals Again
- China – China approves 17 anti-cancer drugs for medical insurance coverage
- Europe – The European Medicines Agency (EMA) has launched a new version of its corporate website
- 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 – FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products
- Europe – Brexit-related guidance for companies
- USA – Complex Generic Drugs: FDA Offers Two Draft Guidances
- USA – FDA OKs Inotersen (Tegsedi) for Hereditary ATTR With Polyneuropathy
- Europe – Falsified Medicines Directive: Implications for parallel importers and of Brexit
- UK – FMD regulations won’t apply after ‘no-deal’ Brexit, says MHRA
- USA – The First FDA-approved Digital Pill – What It Means for Pharma
- USA – Study: Prenatal gene editing treats congenital disease in mice
- UK – Gilead strikes deal with NHS England on Yescarta access
- USA – New Flu Drug Cuts Time to Recovery
- South Korea – S. Korean officials extend seasonal flu vaccine to very young children
- Japan – Japanese study underscores efficacy of HCV drug elbasvir/grazoprevir
- 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 – Drug reaction reporting scheme now more accessible to healthcare professionals
- Europe – UK launch for Alliance’s pregnancy anti-nausea and vomiting drug
- USA – FDA Warns of Dosing Errors With Compounded Injectables
- USA – Drugmakers Call for Changes, Additions to FDA’s Purple Book
- USA – Clinical Trials: FDA Releases Two Draft Guidances
- USA – US green light for Pfizer’s lung cancer drug
- USA – Special 510(k)s: FDA Seeks Input to Expand Eligibility
- Europe – Draft NICE decision rejects Respreeza for incurable, genetic disorder
- Europe – High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin
- Europe – CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys
- USA – Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance
- China – Third Form 483 Surfaces for China Company at Center of Valsartan Contamination
- USA – End of the eCTD? FDA Pushes for New KASA System to Improve Assessments
- USA – J&J files ‘breakthrough’ bladder cancer drug in US
- USA – CDRH Finalizes Guidance to Reduce Heparin Product Overdose Errors
- Europe – NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma
- France – AFAR : soirée BREXIT
- USA – Data Integrity a Top Concern for Manufacturers, FDA Says
- China – Takeda gets China’s approval for $62 billion Shire purchase
- Europe – NICE nod for Novartis’ targeted skin cancer combo
- UK – ‘Streamlined’ medicines regulation promised in ‘No Deal’ Brexit scenario
- USA – US approves AZ’ hairy cell leukaemia drug
- Europe – Regulators Detail Challenges in Defining Orphan Conditions in EU
- USA – ANDA Technical Specifications: FDA Guidance
- 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 – Good clinical practice for clinical trials
- Europe – Dismay as NICE rejects Roche’s MS drug Ocrevus
- Europe – EC green-lights MSD’s Keytruda combo for lung cancer
- Europe – Les mauvais brevets limitent l’accès aux médicaments en Europe
- Europe – Pre-authorisation guidance
- USA – Industry, Pharmacists Call for Changes to FDA Labeling Guidance
- 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
- France – Zelboraf/Cotellic : Rappel du risque d’atteintes opthalmiques et de leur prise en charge
- Europe – Revised Guideline on requirements for revision/renewal of CEPs
- USA – Complex Innovative Trial Designs Pilot Program
- UK – DHSC publishes Brexit guidance for pharmaceutical industry and suppliers of medical devices
- USA – FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation
- Europe – NICE U-turn on Crystiva for rare bone disease
- China – Home-grown colorectal cancer drug approved in China
- 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
- USA – Limit Placebo Use in Cancer Clinical Trials, Says FDA
- Europe – New EU Task Force Unveils Two-Year Regulatory Roadmap to Mitigate Medicine Shortages
- USA – Ascend Therapeutics Draws FDA Untitled Letter Over Estrogel Claims
- Europe – EU approves first CAR-T therapies
- USA – FDA Singles Out Three Drug Substances to Not be Compounded
- Asia – Six Asian Firms Blocked for Refusing FDA Inspections
- USA – FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions
- 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 – Researchers Question Level of Patient Input in Clinical Outcome Assessments in FDA Compendium
- Europe – Esmya: new measures to minimise risk of rare but serious liver injury
- Europe – ICH M9 on biopharmaceutics classification system based biowaivers – Step 2b – First version
- Europe – Brexit Impact: EMA Suspends Publication of Clinical Trial Data
- 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 Approves First Generic Drug to Receive CGT Designation
- USA – FDA Launches New Medication Guide Database
- USA – FDA Finalizes ICH Guidance on Elemental Impurities
- Europe – EC Drafts Guideline on GCP for Advanced Therapies
- Europe – EMA: More Staff Than Anticipated Quit Ahead of Brexit Relocation
- Europe – EMA Consults on Genetically Modified Cell Products Guideline
- Catégorie : International
- 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 E8 General considerations for clinical studies
- International – International regulators discuss available knowledge supporting COVID-19 medicine development
- 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 M9 on biopharmaceutics classification system based biowaivers
- International – ICH Plots Closer Collaboration With PIC/S
- International – WHO publishes its draft Policy brief on traceability of health products for comments
- International – FDA, MHRA Officials Stress the Criticality of Data Integrity in Clinical Trials
- 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 – EU-U.S. trade talks: milestone reached in mutual recognition on pharmaceuticals
- 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 – Two additional countries to benefit from EU-US mutual recognition agreement for inspections
- 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 – Differences and similarities between FDA 21 CFR Part 820 and ISO 13485
- International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections
- International – NICE and Canadian counterpart to offer joint advice service
- International – Biosimilar use may increase with scrutiny of high drug prices
- International – Drug price disclosures could influence consumer thinking, study finds
- International – Industry Comments on ICH Product Lifecycle Management Guideline
- 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 – FDA to Follow EMA With Move From London to Amsterdam
- International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States
- International – Mylan recalls 15 lots of blood-pressure drug containing valsartan
- International – Pfizer to increase some drug prices in 2019
- 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 – EMA Takes Further Action in Ongoing Review of Tainted ‘Sartans’
- Afrique – Les faux médicaments, un fléau pour l’Afrique
- International – Innovative Designs in Early Phase Oncology Studies
- International – Scientists Have Engineered a Potential New Class of Antibiotic That Can Kill Superbugs
- International – Updated: FDA, Health Canada and EMA Spot Second Impurity in Valsartan
- Emerging Market Access Strategy in the Pharmaceutical Industry the example of Thailand – by Thomas Dreyfuss
- International – Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal
- International – WHO Opens Consultation on New Biosimilar Q&A
- Catégorie : France
- Catégorie : Europe
- Catégorie : Amériques
- Catégorie : Asie-Pacifique
- Catégorie : Découverte
- Catégorie : Dispositifs Médicaux
- 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
- Australia – Consultation: Proposed regulatory options for medical devices containing nanomaterials
- 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
- Europe – COVID-19 tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19
- 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
- Europe – European Commission announces appointments to medical device, IVD Expert Panels
- 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
- Europe – Un 18ème organisme vient d’être notifié au titre du RDM : UDEM Adriatic d.o.o. (Croatie)
- 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
- Europe – EC publishes IVDR classification rules and draft standardization request
- 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
- Europe – Euro Convergence: Suboptimal use of MDR grace period is storing up trouble
- 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 – Evaluation clinique : Guide du GMED
- 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
- Australia – Face masks and respirators that are regulated by the TGA
- 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
- Europe – 22 hazardous chemicals added to EU regulation on imports and exports
- 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 – Le GMED enfin habilité au titre du RDM !
- 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
- UK – Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)
- 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
- Europe – European Commission updates on MDR, IVDR implementation timeline
- 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
- Europe – List of harmonised standards that the EC is asking CEN and CENELEC to review for use in the MDR and the IVDMDR
- 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 – Comment rendre un implant orthopédique connecté et intelligent
- 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 – MDCG 2020 – 5 : Clinical Evaluation – Equivalence A guide for manufacturers and notified bodies
- 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
- USA – FDA finalizes medical device post-inspection feedback guidance
- Europe – The European MDR and human factors engineering: Use-related risks
- Europe – COVID-19 IVD quality problems drive EC guidelines
- Europe – HPRA Medical Devices Newsletter – Issue 50 – April 2020
- 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
- Australia – Manufacturing medical devices for COVID-19 including 3-D printing
- 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
- Europe – Hungarian Notified Body is 12th to be Designated Under MDR
- 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
- Europe – Legacy Devices: How MDR Alters the Landscape
- 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 – Et le 11ème organisme notifié habilité pour le RDM est…le NSAI (Irelande)
- 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
- UK – MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies
- 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
- Canada – Health Canada Creates New Medical Devices Directorate
- 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
- Europe – 3D-Printed Breast Implants Could Be the Next Big Thing in Plastic Surgery
- 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
- Europe – First Netherlands-Based Notified Body Designated Under MDR
- 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 – Une solution dédiée à l’impression 3D de modèles anatomiques réalistes
- 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 – Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices
- 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
- Europe – EC Unveils First Notified Body Designation Under IVDR
- USA – FDA Issues Two Final Guidances on Guidewires, Catheters and Delivery Systems
- USA – FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials
- UK – Medical devices regulation in the event of no deal
- 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 – CDRH Takes First Step to Operationalize New Safety and Performance Based Pathway
- 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
- Europe – European MDR covers cosmetic and aesthetic products: Are these firms ready?
- 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
- USA – FDA Finalizes Guidance on Metal Expandable Biliary Stent 510(k)s
- Brazil – Brazil’s ANVISA now requires electronic submissions of medical device FSCAs
- Australia – Australian TGA finalizes medical device and IVD cybersecurity guidance
- USA – FDA Recognizes Standards for Medical Device Interoperability, Safety Assurance Cases
- 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
- USA – First FDA-Developed Medical Device Development Tool Receives Qualification
- 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
- Europe – EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays
- 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
- Europe – May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says
- USA – CDRH Drafts Guidance on Mouse Embryo Assays
- UK – Biggest Regulatory Challenge is Software Safety
- 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 – EUDAMED UDI Device Data Dictionary
- 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 – Draft guideline on quality requirements for medical devices in combination products
- 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
- International – IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices
- 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
- Europe – TÜV SÜD Becomes Second NB to be Designated Under EU MDR
- 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
- USA – Industry raises concerns with FDA guidance on post-inspection feedback
- International – Trends in Healthcare and Medical Device Manufacturing
- International – 9 human factors pitfalls to avoid for safer orthopedic surgical devices
- Europe – Brexit update: Extension to October 31, 2019
- Europe – New long-lasting implant to treat opioid dependence
- USA – FDA Finalizes Guidance on Convenience Kit UDI Marking
- USA – FDA Finalizes Guidance on UHMWPE in Orthopedic Devices
- International – IMDRF Takes Another Stab at IVDs, MDSAP
- USA – FDA Finalizes Guidance on Non-Clinical Bench Performance Test Reports for Device Submissions
- 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 – FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products
- USA – There’s a New Weight-Loss Device in Town and TPS Is Its Name
- USA – CDRH : New steps to help reduce risks associated with surgical staplers for internal use and implantable staples
- USA – FDA : New steps to strengthen the process of initiating voluntary recalls
- USA – FDA permits marketing of first medical device for treatment of ADHD
- Japan – Japanese regulators extend participation in Medical Device Single Audit Program (MDSAP)
- 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 – MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR
- USA – Experts Tell Device Companies Not to Fret Over QMS Transition
- Europe – Investigational site and personnel selection for medical device clinical studies
- USA – FDA stops all US sales of Surgical mesh intended for transvaginal repair of pelvic organ prolapse (POP)
- Europe – EU Device Coordination Group Offers Eudamed Guidance
- Europe – RDM et RDMDIV : les fabricants dans l’attente des organismes notifiés
- Europe – European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit
- USA – Purified Fat Could Be an Alternative to Breast Implants
- USA – FDA Reclassifies Certain Device Accessories to Class I
- USA – FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion
- Europe – Préparation à un Brexit sans accord: la Commission européenne dresse le bilan des préparatifs et fournit des orientations pratiques pour garantir une approche coordonnée au niveau de l’UE
- USA – FDA Removes 9% of Medical Device Registrations from Database
- UK – Virtual manufacturing of medical devices
- UK – ‘Use greener asthma inhalers’, encourages NICE
- USA – FDA’s De Novo Program Gains Momentum
- USA – US FDA identifies hundreds of device types affected by sterilization facility closures
- Australia – An Action Plan for Medical Devices
- 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 ?
- Japan – Japanese regulators increase medical device registration fees for 2019
- USA – US FDA targets safety of materials used in medical devices
- USA – FDA wants public input on AI-enabled device regulation
- USA – FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD
- Europe – MedTech Europe Flags MDR/IVDR ‘Burning Points’
- Ireland – No-deal Brexit could affect accessibility of 40% of devices in Ireland
- Europe – GDPR and human factors studies for medical devices: Key issues for manufacturers and sponsors
- USA – FDA Proposes Radiological Health Deregulatory Action
- USA – FDA Classifies IVDs for Bacillus Detection
- 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 – CDRH Proposes New IMDRF Work Item on Standards
- 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 – MHRA Guidance on a No-Deal Brexit
- Europe – European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario
- Europe – Brexit delay: Reduced risk of no-deal withdrawal for medical device manufacturers?
- Europe – EU MDR/IVDR Coordination Group Urges Exemption Clarification
- USA – FDA’s OCP Works to Modernize Review Functions
- 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
- Europe – EU Publishes First Corrigenda for MDR, IVDR
- UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices
- USA – CDRH to Review Materials Used in Medical Devices
- USA – FDA Wants to Take a Hard Look at Medical Device Materials
- Australia – Australian medical device regulators preparing Brexit contingency plans
- Europe – Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)
- USA – CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials
- Canada – Health Canada Begins Release of Clinical Data on Drugs and Devices
- USA – CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders
- USA – CDRH Qualifies 3rd Medical Device Development Tool
- USA – Top 10 Patient Safety Concerns in 2019
- Europe – Medical devices: the shift from embedded to connected
- Europe – EUDAMED : Draft Functional specifications
- Europe – Première version des spécifications communes pour consultation publique des Etats membres de l’UE
- USA – Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines’ Initial Release
- Italy – Italian medical device nomenclature to be adapted for Eudamed database
- Australia – TGA Proposes 5 Medical Device Classifications in Line With EU MDR
- 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
- USA – CDRH Classifies Software App for Contraception into Class II
- USA – Gottlieb to Resign as FDA Commissioner
- Israel – Startup develops electrospinning device for wound treatment
- Europe – EUDAMED – la nomenclature CND va remplacer celle du GMDN
- USA – Capturing Device Identifiers for Non-Sterile Orthopedic Implants at Point of Care
- 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
- International – Innovation, Personalization Power 3D-Printed Medical Device Market
- China – Chinese scientists develop nanogenerator for cancer drug delivery system
- UK – Parallel imports of medical devices
- Europe – No-deal Brexit: Key Questions for Medical Device Companies
- USA – FDA warns consumers to avoid using thermography devices to detect breast cancer
- USA – CDRH Issues Guidance on Brain-computer Interface Devices
- USA – Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect
- 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 – CDRH Classifies Auto Titration Device for Oral Appliances
- Switzerland – Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) – updated information
- USA – FDA issues draft guidance on non-binding feedback on inspections
- USA – CMS now covers Clarify’s phototherapy psoriasis treatment
- Australia – TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices
- 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
- Australia – Australia Proposes to Reclassify Spinal Implants in Line With EU MDR
- UK – Medical devices: information for users and patients
- USA – Exemptions for Unclassified Devices: CDRH Updates Guidance
- USA – Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds
- USA – 7 Pro Tips for New and Aspiring Roboticists
- USA – Combo Product Reviews: FDA Drafts Guidance
- USA – Behind the Invention: Wearable Artificial Kidney
- UK – New UK conformity mark to replace the CE mark in a « no-deal » scenario
- USA – CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions
- Europe – Another Reason to Update Your Biocompatibility Approach: EU MDRs
- Europe – Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer
- USA – GS1 Guidance to Support Point-of-Care Scanning of UDI Data for Implantable Devices
- USA – FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices
- Canada – Health Canada Seeks to Better Define Regulatory Requirements for SaMD
- Europe – US, EU Pledge to Cooperate on UDI Specifications
- China – Hong Kong Medical Device Regulatory Update: IVD listings, acceptance period for NMPA approvals
- China – NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software
- 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 – 510(k) Modernization: FDA Floats Need to Pursue New Authority
- Europe – Survey Highlights Looming Shortfall of IVDR-designated Notified Bodies
- USA – After the Product-Centric Medical Industry – What’s Next?
- UK – UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit
- 3D Printing Prosthetics and Implants With Precision
- 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
- USA – CDRH Revamps 510(k) Clearances With ‘Safety and Performance Based Pathway’
- Europe – Survey on NBs applications against IVD new regulation
- International – 11 innovative medical devices you need to know from 2018
- Europe – Are Wearables Medical Devices Requiring a CE-Mark in the EU?
- India – India’s health ministry accepts eIFU for medical devices
- Europe – EU Lists First Notified Body Under MDR
- USA – Device makers seek transparency on Breakthrough Devices Program
- Europe – Is Progress on MDR and IVDR Happening Fast Enough?
- USA – Wearable device studied for detection of pediatric anxiety, depression
- USA – US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase
- 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?
- USA – Impact of the USMCA on the Medical Device Industry
- Canada – Canada Completes Transition to MDSAP
- USA – Abbott Snags FDA Approval for Neonatal Heart Device
- Europe – Kheiron Medical launches trial of AI algorithm for breast cancer Dx
- Canada – AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices
- China – China’s NMPA Launches Voluntary Device Master File Process
- USA – Wearable dialysis system gains breakthrough designation from FDA
- USA – Seizure Monitoring Smartwatch Cleared for Use in Children
- USA – FDA to Test PreCert De Novo Requests Under Pilot
- Europe – MDR & NBs – L’inquiétude grandit (The worry is growing)
- Europe – Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation
- Australia – Australia Explores Adopting UDI System
- USA – FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’ Corrections
- Australia – TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity
- USA – MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes
- USA – What Will 2019 Bring for Medtech?
- South Korea – S. Korean devicemaker debuts AI-based diagnostics platform
- Europe – European Regulators Publish UDI Guidance
- USA – Medical Device QMS Harmonization: US Considers Aligning to ISO 13485
- China – China FDA Reorganization: Impact for medical device registrants
- International – Predict and Prevent: The Emergence of Real-Time Sensor-Based Care
- USA – Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny
- USA – FDA Reclassifies Some ECT Devices
- Canada – Health Canada Details Medical Device Action Plan
- Europe – Brexit Contingency Action Plan Issued by European Commission
- USA – US Regulatory Landscape for Medical Devices: A Year in Review and a Look Ahead
- USA – US FDA Finalizes Guidance on Breakthrough Medical Device Pathway
- USA – FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance
- USA – Medical device industry regulation is changing: What you need to know
- Canada – Health Canada Setting Pre-market Medical Device Cybersecurity Requirements
- USA – Considering Old and New 510(k) Predicates
- USA – FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices
- USA – FDA Finalizes Rule to Simplify Medical Device Classification Procedures
- USA – FDA Finalizes Guidance on Changes to Device Manufacturing Sites
- Europe – La Ph. Eur. révise le chapitre général sur la spectrophotométrie infrarouge
- Europe – Révision : guideline sur la validation des systèmes informatisés
- Europe – Rushing to EU MDR deadline could disrupt supply, delay approvals
- 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
- Australia – Regulation of Software as a Medical Device
- Europe – EU Commission adopts REACH nano changes
- USA – FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
- Europe – Brexit Update: New Notified Body Designated in The Netherlands
- Canada – Canada’s MDSAP Transition Deadline Fast Approaching
- USA – FDA Drafts Guidance on Oncology Companion Diagnostics
- USA – Benefits of ERP in an FDA-Regulated Environment
- Europe – Evaluations conjointes des organismes notifiés dans le secteur des dispositifs médicaux : état des lieux
- USA – FDA Proposes Rule to Implement New De Novo Classification Process
- UK – Are Smaller Hip Implants in Older Patients More Cost Effective?
- Europe – Déployer des dispositifs médicaux IoT en toute confiance
- Canada – Health Canada to Release Action Plan for Medical Devices Amid Reports of Faulty Implants
- USA – Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions
- China – What does the U.S.-China trade war mean for medical device companies?
- China – Hong Kong Regulators Launch Online IVD Classification Tool
- Europe – Diabeloop Is 2nd to Win CE Mark for Artificial Pancreas System
- Germany – New Virtual Surgical Simulator Debuts in Germany
- USA – FDA issues revised draft guidances for blood glucose monitors
- UK – Concept Device Designed to Tame Menopausal Hot Flashes
- USA – First Device Cleared for the Prevention of Cluster Headache
- USA – FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems
- USA – CDRH Redrafts Policies on CLIA Waivers for IVDs
- Canada – Health Canada Proposes Changes to Priority Review Requests for Medical Devices
- USA – Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators
- Europe – European MDR Transition: Update at the Halfway Point
- USA – New steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
- USA – Does More FDA Oversight Equal Better Compliance?
- Europe – European Medical Device Regulation: The Compliance Advantage
- Europe – Diagnostics Are Helping Counter Antimicrobial Resistance, But More Work Is Needed
- USA – CDRH Touts Uptick in Foreign Device Inspections
- Europe – 7 Things That Have Medtech Companies Thankful in 2018
- USA – Intracranial Hemorrhage Detection Software Receives FDA Clearance
- USA – FDA – MD Safety Action Plan to enhance post-market safety : Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health
- International – Google’s Verily spikes glucose-sensing lens project with Novartis’ Alcon
- USA – FDA Proposes New Framework on Prescription Drug-Related Software
- Europe – Is Progress on MDR and IVDR Happening Fast Enough?
- Europe – Draft Brexit Agreement’s Implications for Medical Device Sector
- Europe – BSI achieves Designation for its Netherlands Medical Devices Notified Body
- How Digital Health Technologies Could Make a Difference
- Europe – NEW REGULATION – GUIDANCE
- Israel – How One Digital Health Company is Outsmarting Diabetes
- USA – Benefits of ERP in an FDA-Regulated Environment
- UK – Abbott’s wearable glucose monitor to be available across England
- USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs
- Australia – Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018
- Malaysia – Malaysian Regulators Launch New Medical Device Databases
- USA – Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating
- USA – Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver
- China – Chinese Regulators Revamp Innovative Medical Device Review Process
- USA – UL Wades into Cybersecurity of Connected Medical Devices
- USA – US FDA Updates UDI Policy for Direct Marking of Medical Devices
- Europe – MDR and IVDR Implementation: Update from the European Commission
- Europe – Manual on Borderline and classification in the Community Regulatory Framework for Medical Devices
- USA – FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
- USA – Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years
- USA – CDRH Issues Final Orders on Medical Devices for Insulin Adjustment, Drug Screening
- USA – FDA Withdraws Proposed Rule on Electronic Labeling for Certain Devices
- USA – FDA isn’t doing enough to prevent medical device hacking, HHS report says
- USA – US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot
- Europe – EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns
- USA – Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?
- USA – FDA Issues New Classification for Implantable Bone Conduction Hearing System
- France HEMARINA named National French Start-Up of the Year by EY
- USA – CDRH Works on Clinical Objectivity in Patient-Reported Outcomes
- USA – How electronic skin tech is improving home wearable devices
- USA – Top 10 Medical Innovations for 2019
- USA – First Version of NEST to Launch in 2019
- UK – Decide if your product is a medicine or a medical device
- USA – US FDA Publishes Highly Anticipated Update to Medical Device Cybersecurity Recommendations
- South Korea – South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO 13485:2016
- Europe – MDCG WORKING GROUP : Notified bodies, UDI, …
- USA – Device Firms to Inform New FDA Framework on Servicing
- USA – UDI: 5 Opportunities You May Not Have Considered
- USA – CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices
- Australia – TGA Proposes Regulation on IVD Companion Diagnostics
- International – Artificial Intelligence : the Future in Healthcare and Medical Device Manufacturing
- USA – FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews
- International – Novartis, Foundation Medicine collaborate on companion diagnostics
- Italy – Valeritas launches wearable insulin delivery device in Italy
- Europe – EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes
- International – 25 Medtech Startups You Need to Know
- USA – 7 electronic design problems that boost medical device costs
- USA – Your device design looks great. Now how do you get reimbursement?
- USA – FDA Tweaks List of Recognized Consensus Standards for Devices
- Europe – European Commission Offers Guidance on UDIs
- Europe – EU Releases Working Plan to Implement MDR/IVDR
- USA – Cybersecurity: FDA Spells Out Updated Premarket Policies
- USA – CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator
- UK – Regulator seizes almost 10,000 unsafe STI + HIV test kits
- USA – US FDA Clarifies Human Subject Requirements for Clinical Investigations
- USA – Doctors to monitor hip, knee surgery patients using Apple Watch
- China – Scientists create color-changing lenses for delivering eye treatments
- 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
- Europe – Medical devices: EU regulations for MDR and IVDR
- Canada – Health Canada: MDSAP Could Force Some Manufacturers Out
- Canada – Health Canada Developing MDL Policies for 3D-Printed Medical Devices
- Europe – KPMG and RAPS: Medical Device Companies Under-prepared for European MDR
- USA – Cybersecurity: CDRH to Update 2014 Premarket Policies
- USA – AdvaMed Backs Wright Medical in Hip Liability Case
- International – Body Vision Releases LungVision for Early-Stage Lung Cancer Diagnostics
- USA – CDRH Works to Develop Proposed De Novo Regulation
- UK – Notify MHRA about a clinical investigation for a medical device
- USA – Continuous Quality: FDA’s Goal for the Case for Quality Program
- USA – Eximo Medical’s Atherectomy Laser Cleared by FDA
- China – Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List
- USA – Self-Fitting Hearing Aid Receives Nod from FDA
- UK – Roche CoaguChek device producing inaccurate results
- USA – US FDA’s Medical Device Division Lays Out Regulatory Guidance Plans for 2019
- UK – UK’s NICE recommends Procept’s robotic system for BPH
- Europe – Abbott’s glucose monitoring system with real-time alarms wins EU nod
- 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.
- Europe – TÜV SÜD Survey: Expected Shortage of Notified Bodies Under EU MDR/IVDR
- USA – CDRH Offers Look at Upcoming Guidance Documents in FY 2019
- USA – US FDA Launches Pilot to Expand Special 510(k) Market Pathway
- Europe – Digital health projects win £17 million
- USA – Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved
- USA – Gottlieb Defends Digital Health Approach
- USA – Philips Unveils Augmented Infant Resuscitator for Safe Rescue of Asphyxiated Newborns
- USA – IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways
- USA – FDA Reduces Regulatory Burden for Female Condoms
- USA – US Regulators Update Policies for Medical Device Voluntary Consensus Standards
- 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
- USA – Device Makers Call for Changes to FDA’s Biliary Stent Guidance
- UK – Notify MHRA about a clinical investigation for a medical device
- USA – MYnd Analytics stock rallies after FDA gives breakthrough status for company device
- Europe – Are You Really Ready For MDR?
- USA – FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert
- USA – FDA rolls out plan to reduce third party 510(k) re-reviews
- USA – Appropriate Use of Consensus Standards: FDA Issues Draft and Final Guidance
- USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps
- USA – Device Firms to Prep for Electronic Submission Shift Under FDA Proposed Rule
- USA – FDA Looks to Make FOIA Process Easier
- USA – FDA to bolster cybersecurity of medical devices
- Canada – Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers
- USA – US FDA Rolls Out Pilot for Simplified 510(k) Submissions
- 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
- USA – CDRH Works With IMDRF to Establish a Medical Device Single Review Program
- USA – FDA Clarifies Policies on Acceptable Levels of Uncertainty for Devices
- UK – Versius Robotic Surgical System Unveiled by UK Company
- USA – Two New Penumbra Catheters to Suck Out Stroke-Causing Clots
- USA – Theranos is Reportedly Shutting Down for Good
- USA – A Few Things SaMD Developers Should Know
- Europe – Electronic implant offers hope for preventing epileptic seizures
- Europe – Europe Update: Notified Body MDD, AIMDD Timelines
- USA – Researchers Call on FDA to Tighten Requirements for Breakthrough Devices
- Europe – Taking a Deeper Look at Device Certification and Recertification
- USA – ISO Preps for FDA’s Proposed Overhaul of Device Quality System Regulation
- Discovery – Eye Test to Detect Alzheimer’s Disease Before Symptoms Start
- USA – Updated: FDA Warns Zimmer Biomet’s Indiana Plant
- USA – 6 Questions to Ask Yourself about ISO 11607 Compliance
- USA – FDA plans to use ISO 13485 for medical devices regulation
- Discovery – FlexDex Intuitive Laparoscopic Instruments Going on Sale in U.S.
- USA – Medical Device Validation: What You Need to Know and Why It’s Important
- USA – New Hip Replacement Procedure Launches
- Discovery – Vagus Nerve Stimulation Highly Effective at Treating Drug Resistant Depression
- USA – A Temporary Fix for the EpiPen Crisis?
- Canada – Health Canada to Adopt IMDRF Table of Contents Format
- Australia – Expands Range of Acceptable Foreign Regulators for Device Applications
- USA – FDA Medical Device Safety Action Plan: Good or Bad for Medtech?
- Discovery – VistaTablet for Monitoring Patients’ Eight Vital Signs from Anywhere
- Discovery – Building a Better Insulin Infusion System
- Dispositifs Médicaux – AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan
- USA – FDA Issues Two Final Guidances on Communications Not Included In Product Labeling
- USA – FDA Approves First Generic Versions of EpiPen
- USA – FDA Approves First Contraceptive Mobile App
- Australia – TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance
- USA – FDA Targets Unapproved Vaginal Rejuvenation Devices
- USA – AngioDynamics to Pay $12.5M to Settle Allegations Over Two Unapproved Devices
- Découverte – Recherches bibliographiques pour l’évaluation de la performance clinique
- Catégorie : International
- International – Norme ISO 14155:2020 : quels changements pour quels impacts ?
- International – L’IMDRF publie un document concernant la classification des DMDIV
- International – Facebook développe une montre connectée tournée vers la santé
- Saudi Arabia – Saudi classification guidance explicates submissions process and product changes
- International – January’s Regulatory Focus: The impact of disruption on the global regulatory community
- International – WHO’s Essential Diagnostics List updated for COVID-19
- Egypt – Egypt will begin requiring registration of IVD reagents
- International – La norme ISO 10993-21 est publiée
- International – Intellectual Property at the Intersection of Medical Devices and Artificial Intelligence
- International – Design with the end in mind
- International – Cold chain management for COVID-19 vaccines: Ensuring safe and effective distribution
- WEBINAR – VACCINS ANTI-COVID De quoi parle-t-on ?
- International – Roche links with Moderna to include antibody test in COVID-19 vaccine trial
- International – MDSAP Council updates guidance on conformity assessments and related requirements
- International – Turkish Notified Body TSE no longer available for European IVDD
- International – Amendement de l’IEC 60601-1-2 : quel sera l’impact sur les fabricants ?
- International – IMDRF proposes update on postmarketing device studies
- International – 2020 amendments to IEC62366 – implications for medical device usability engineering
- Russia – Russian Ministry of Health articulates role of SaMD in medical device regulation
- International – Medical Device Innovation Consortium Releases Real-World Evidence Framework for In Vitro Diagnostics
- International – Strategies to Prevent Component Shortages During a Crisis
- International – EU OKs coronavirus test from Macrogen
- International – 10 steps to conducting a use-related risk analysis as part of your Human Factors Engineering process
- International – Researchers develop prostate cancer blood test
- International – ISO/TR 20416:2020 – Surveillance après mise sur le marché incombant aux fabricants
- International – Demonstrating medical device cyber risk management to regulators and clients
- International – Recasting CAPA as a continuous improvement process
- International – (CFR) 21 part 820.30 : Design verification and validation versus human factors validation
- International – ISO/TR 24971:2020 – Guidance on the application of ISO 14971
- 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 – Medical Writing: The Language and Art of Scientific Communication
- International – Using risk management to support outsourcing activities
- International – IMDRF medical device cybersecurity guidance recommends UL 2900 compliance
- International – EFTA countries and Russia introduce COVID-19 policy changes
- International – Antiviral and Antimicrobial Additive Developed for Face Masks, Medical Apparel
- International – Implications of the new ISO 14971 edition for usability engineering
- International – IMDRF finalizes guidances on cybersecurity, personalized devices and conformity assessment bodies
- International – IMDRF Consultations Focus on IVD Classifications, Regulatory Assessors
- International – COVID-19: Daily Report for Life Sciences and Health Care Companies
- International – Le In Silico bientôt supplanté par les Organoïdes
- International – ISO 14971 : 2019 – GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013
- International – WHO publishes its draft Policy brief on traceability of health products for comments
- Saudi Arabia – Saudi FDA extends GHAD deadlines, issues guidance documents
- International – DM et Phtalates
- International – Improving Biosecurity with first International Standard for Biorisk Management
- International – Unique Device Identification and Recall Management: Starting with the Patient in Mind
- International – WHO Drafts Policy on Designating Regulators as Listed Authorities
- International – 2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020
- International – Nouvelle version 2019 de la norme ISO 14971:2019
- Saudi Arabia – Saudi FDA moves to single electronic platform for medical device registrations
- International – Report: Medtech-related adverse events more in women than in men
- International – The Transformation of Digital Health: What it Means for Regulatory Professionals
- International – Des implants rachidiens plus performants grâce à l’impression 3D
- International – Breaking down “universal,” “inclusive,” and “accessible” medical device design
- Israel – Le premier implant de ménisque artificiel au monde réalisé en Israël
- International – Connected injection devices: Human Factors Challenges
- International – Value of Human Factors Engineering for ancillary adherence technologies in clinical studies
- International – L’usage de la vidéo au service de la recherche clinique
- International – Un vecteur d’innovation qui dépasse largement le cadre du DM sur mesure
- International – Révision de la norme ISO 10993-18 : introduction au concept de l’AET
- International – IMDRF Offers Three Final Clinical Guidelines
- International – Evolving Global Regulatory Landscape, Strategies and Best Practices
- International – Guide to improve usability for wearable injector devices
- International – IMDRF New Guidance : Principles and Practices for Medical Device Cybersecurity
- International – 3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks
- International – DM connectés : de l’aptitude à l’utilisation à l’expérience utilisateur
- International – Patent Considerations for Connected Medical Devices
- Saudi Arabia – Saudi Arabia medical device market update: MDMA fee increases, new regulations in the works
- International – Cybersecurity becomes critical for hospitals buying devices
- International – The convergence of medical device cybersecurity requirements in Australia, Canada and the USA
- International – Disinfecting Devices at the Point-of-Care
- International – IMDRF Opens Consultation on Annex Related to Adverse Event Terminology
- International – What Could Blockchain Technologies Mean for the Medical Device Industry?
- International – Implementing the IEC 60601-1 Medical Electrical Equipment Standard
- International – WHO’s five-year plan to help build effective and efficient regulatory systems
- International – Human factors studies: Considerations for recruiting rare and complex user populations
- International – WHO Updates Lists of Essential Medicines, Diagnostics
- International – IMDRF Releases New and Revised Documents Following March Meeting
- International – 3 Critical Considerations for Evaluating Off-the-Shelf Software for Medical Devices
- International – Medtech Salary Survey 2018
- International – Regulatory Recap: Global Trends June 2019
- International – Regulatory Recap: Global Trends June 2019
- International – WHO Outlines Process to Designate Regulators as WHO-Listed Authorities
- International – Regulating Software as a Medical Device in the age of Artificial Intelligence
- International – 10 of the Most Influential Companies in the Cardiovascular Space
- International – Taux de croissance de la production du marché des dispositifs médicaux connectés 2019-2025
- Saudi Arabia – Saudi FDA regulatory update: MDR, UDI and Brexit
- International – GHTF final documents (updated)
- International – IMDRF Documents (updated)
- International – WHO Guideline: recommendations on digital interventions for health system strengthening
- International – Calculating Sample Sizes For Human Factors Studies: What’s The Magic Number?
- International – WHO Drafts Global Strategy on Digital Health
- International – Top 5 issues for medical device risk management and design controls
- France – Trois fabricants partagent leur expérience de la mise en conformité à l’UDI
- International – Is your software a medical device?
- Brazil – Brazil’s ANVISA launching Notification pathway for low-risk medical devices and IVDs
- International – Transition to ISO 13485:2016 Comes to an End
- International – A Look at the Competitive Landscape of Diabetes Devices
- India – Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices
- International – WHO Advances International Harmonized Nomenclature for Medical Devices
- International – Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?
- International – Human Factors Engineering and Usability: What you should know about diary studies
- Israel – New Israeli fund to support medical device development
- International – CE Mark suspended for Endologix Nellix stent graft
- International – REACH FAQs for Medical Device Professionals
- International – IMDRF Gains Ground with Plans for a Medical Device Single Review Program
- Ireland – Ireland’s research center for medtech eyes animal testing facility
- India – Roche Diagnostics launches cervical cancer screening lab in India
- International – Beta Bionics Wins Readers’ Choice for Medtech Company of the Year
- International – Injecting quality into software development with industry-specific guidance on ISO 9001
- India – India Adds Four Medical Device Types to CDSCO List of Regulated Products
- India – India still lacks comprehensive regulations for medical devices
- International – Could AI Become the New Quality Control Manager in Medical Device Manufacturing?
- International – No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security
- International – REACH FAQs for Medical Device Professionals
- International – Emergo by UL Regulatory Recap: Global Trends November 2018
- International – ISO 14155 Third Edition Preview: Role of Risk Management in Clinical Investigations
- International – Investigative Report Casts a Troubling Light on the Medical Device Industry
- International – Cybersécurité : un sujet à prendre au sérieux pour les dispositifs médicaux
- International – 5 award-winning medical device innovations for unmet needs
- International – Livre blanc sur les rapports d’évaluation clinique dans l’industrie des DM
- International – Les points clés pour faire de l’IoT une opportunité dans le domaine du DM
- International – Industrie medtech : léger fléchissement de l’indice LIMEDex
- International – IMDRF Finalizes Work on Standards for Regulatory Use, Essential Principles, Personalized Devices
- International – MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016
- International – Global spinal fusion devices market poised for growth
- International – Surgical Robotics Market Due for a Shake Up?
- International – ISO 13485 : ISO board seeks feedback on quality systems standard
- Saudi Arabia – Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions
- International – FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK
- Brazil – Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions
- International – Insights on Upcoming Revisions to ISO 13485
- International – 5 Innovative Trends of the Future in Healthcare and Medical Device Manufacturing
- International – ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations
- India – India Medical Device and IVD Regulatory Update: September 2018
- International – With new blood test, Roche dives deeper into personal cancer care
- Australia – Australia Unveils Strategy for Engaging With Foreign Regulators
- Brazil – Brazil’s ANVISA Readies Regulations for Custom-made Medical Devices
- Australia – Australian TGA to Accept Medical Device Approvals from Additional Overseas Regulators
- International – Device Makers Combating Cyber Risks to Patient Health
- International – Alcon Pulls CyPass Micro-Stent from Market Based on Long-Term Safety
- International – Immersive Technologies in Medical Device Development: Today and Tomorrow
- International – Boston Scientific Speaks Out About Pelvic Mesh Controversy
- Catégorie : France
- France – N°3 – DM : veille en un clin d’œil
- France – Cartographie industrielle de la filière diagnostic dans le Sud de la France
- France – COVID-19 : l’ANSM suspend la commercialisation du « spray nasal COV-Defense » et « spray nasal Biokami »
- France – Classification fonctionnelle, selon leur finalité d’usage, des solutions numériques utilisées dans le cadre de soins médicaux ou paramédicaux
- France – Un masque décontaminant contre la Covid-19 et ses variants a été mis au point avec l’Université de Lille
- France – Masques Barrières à usage sportif : un guide pour les fabricants
- France – Méta-analyse de l’intérêt diagnostique des tests RT-PCR salivaires de détection du SARS-CoV-2
- France – Ordre du jour de la réunion du 9 février du Comité d’interface Groupe de travail « Règlements DM/DMDIV » de l’ANSM/ Organisations professionnelles représentatives des industries des DM/DM-DIV
- France – Cette entreprise française produit des verres de lunettes pour les daltoniens
- France – AFNOR Certification, 2ème organisme notifié français : à quelle échéance ?
- France – N°2 – DM : une veille en un clin d’œil pour joindre l’utile à l’agréable
- France – Un coeur artificiel installé à vie pourrait être bientôt commercialisé
- France – Rapport annuel d’activité 2019 sur les évènements indésirables graves associés à des soins (EIGS)
- France – Joël Ankri est nommé président du Conseil scientifique de l’ANSM
- France – Programme Breakthrough Device : un raccourci vers le marché américain
- France – IQSS 2020 – ETE ORTHO : Événements thrombo-emboliques après pose de prothèse totale de hanche ou de genou
- France – Distributeurs de produits de santé remboursés
- France – Cartographie des impacts organisationnels pour l’évaluation des technologies de santé
- 2021 ! Année de l’espérance
- France – Le parcours de Christelle Ratignier-Carbonneil, nouvelle directrice générale de l’ANSM
- France – Comité d’interface Agence nationale de sécurité du médicament et des produits de santé / Organisations professionnelles représentatives des Industries des DM/DM-DIV
- Europe – Brexit : préparer le marquage de conformité UKCA en 10 étapes
- France – La propriété intellectuelle : une nécessité pour protéger son DM
- France – Réformer notre système de santé : l’atout décisif des dispositifs médicaux innovants
- France – HAS : Revue rapide sur les tests RT-LAMP sur prélèvement salivaire (hors système intégré de type EasyCoV)
- France – HAS : Revue rapide sur les tests RT-PCR SARS-CoV-2 sur prélèvement salivaire
- France – La HAS détaille l’évaluation des dispositifs médicaux embarquant de l’IA
- France – L’analyse physico-chimique dans l’évaluation biologique des DM
- France – Concept de garantie humaine : quels enjeux pour les fabricants de DM ?
- France – Diabète: prise en charge du système d’autosurveillance Dexcom G6
- France – Le SNITEM met à jour sa collection de livrets synthétique relatifs au MDR
- France – COVID-19 : une crise qui n’épargne pas le secteur du dispositif médical
- France – Une technologie de mesure 3D adaptée aux besoins des DM
- France – Evaluation des DM embarquant de l’IA en vue de leur remboursement
- France – Rapprocher les concepteurs de DM des utilisateurs
- France – ANSM : Rapport d’activité 2019
- France – La HAS guide les demandes d’évaluation de DM embarquant de l’intelligence artificielle
- France – Implant files : le Tribunal Administratif contraint le GMED de dévoiler certaines informations qu’il jugeait confidentielles
- France – HAS : Un nouvel outil pour l’évaluation des dispositifs médicaux embarquant de l’intelligence artificielle
- France – Loi anti-cadeaux : nouvelles dispositions présentées par Simmons & Simmons
- France – La simulation multiphysique pour innover en diagnostic in vitro
- France – Dispositif anti-cadeaux : la dernière pièce du puzzle réglementaire publiée
- France – Patch de micro aiguilles : une avancée pour la thérapie photodynamique
- France – Le décret no 2020-1090 du 25 Août 2020 modifie les conditions de la prise en charge des DM connectés
- France – La LOI n° 2020-105 du 10 février 2020 interdit (art. 82) les microplastiques et d’autres substances dans les DM en 2024
- France – Un Guichet unique pour accompagner l’innovation
- France – Renouvellement de la présidence et du Bureau de l’APIDIM
- 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 -ANSM : Diabète : prudence avec les applications permettant de créer soi-même un système de délivrance automatisée d’insuline
- France – HAS : Forfait innovation (maj)
- France – ANSM et COVID-19 – Demandes de visas publicitaires de DM et DMDIV
- France – Prothèses PIP : la Cour de Justice confirme des indemnisations réservées aux victimes françaises
- France – Logiciel dédié à l’enregistrement en ligne de dispositifs médicaux
- France – France Biotech annonce la création d’un nouveau groupe de travail dédié au « Market Access » des sociétés innovantes en santé
- France – Coronavirus & dispositifs médicaux : et demain ?
- France – Qualification de dispositif médical : quoi de nouveau sous le soleil ?
- France – La contribution sur les dépenses de promotion des dispositifs médicaux
- France – Nordson EFD aide les fabricants à répondre à la demande de DM pour traiter le COVID-19
- France – La HAS se prononce sur les tests sérologiques rapides – TDR, TROD, autotests – dans la lutte contre le COVID-19
- France – Evaluation clinique et valorisation des DM connectés à l’ère future du RDM
- France – La HAS soumet à consultation publique un projet de grille de classification fonctionnelle des solutions numériques selon leur finalité d’usage.
- France – Dépistage massif du coronavirus à l’aide de caméras IDS
- France – Patch à base de graphène pour la télésurveillance des plaies
- France – COVID-19 : dépistage PCR et diagnostic sérologique (Arrêté du 14 Avril 2020)
- France – Deux nouveaux bénéficiaires du Forfait Innovation, dont le cœur Carmat
- France – Développement et fabrication de DM implantables actifs
- France – Des outils d’aide à la surveillance post-commercialisation de DM
- France – Le pôle Medicen recense les initiatives contre le Covid-19
- France – Coronavirus : Thuasne se lance dans la production de masques barrières réutilisables
- France – SNITEM : un tableau simple pour mieux comprendre l’UDI en pratique
- France – Du collagène capable de réparer les vaisseaux sanguins
- France – Les changements avec le RDM : le livret explicatif et pédagogique du SNITEM (Mars 2020)
- France – Un DM plus discret grâce à la simulation acoustique
- France – HAS – Webinaire sur l’évaluation des dispositifs médicaux : visionnez le replay
- France – Contraception : pourquoi l’agence du médicament rappelle certains anneaux vaginaux
- France – Avis CNEDIMTS (HAS) sur les DM (2020)
- France – Le Cœur CARMAT (CARMT TAH) éligible au forfait innovation (HAS) sous conditions de nouvelles données cliniques
- France – Remboursement de DM : un webinaire de la HAS pour réduire les non-conformités
- France – ANSM – Comité d’interface du 6 Février – EUDAMED
- France – Arrêté relatif à l’obligation pour un distributeur de détenir un accord de distribution avec le fabricant ou son mandataire
- France – L’industrie française du matériel médical s’estime pénalisée par les lenteurs réglementaires
- France – Relations entreprises – influenceurs : le décret est publié
- France – Relations entreprises – influenceurs : le décret est publié
- France – Conférence finale du projet JAMS sur les dispositifs médicaux : un modèle de coopération européenne piloté par l’ANSM
- France – HAS : Projet de grille d’analyse pour l’évaluation de dispositifs médicaux avec intelligence artificielle
- France – La HAS soumet à concertation sa grille d’analyse des dispositifs médicaux embarquant de l’IA
- France – Des solutions et services pour faciliter l’accès aux technologies connectées
- France – Santé 4.0 : un patch intelligent pour mesurer les paramètres vitaux
- France – Interview choc : les points sensibles des contrats avec les organismes notifiés par Maître Alexandre Regniault, Avocat associé chez Simmons & Simmons
- France – Quand le logiciel devient un “dispositif médical”
- France – Dispositifs médicaux: une plateforme de dépôt des dossiers auprès du CEPS effective en 2020
- France – Le référencement des verres ophtalmiques
- France – Trois nouveaux DU pour maîtriser les nouvelles exigences réglementaires du Dispositif Médical
- France – Dispositifs médicaux : le nouvel horizon réglementaire
- France – Vers une jurisprudence ?
- France – Dispositifs médicaux » Sequent Please » et » Sequent Please Neo » annulation du refus de prise en charge
- France – La norme ISO 11607-1 subit une révision majeure
- France – SNITEM & EUROPHARMAT : Guide sur l’application du MDR
- France – Permettre un accès privilégié au marché aux DM les plus innovants
- France – Cœur Artificiel : Carmat lève 60 M€ pour passer au Stade Industriel
- France – Identification individuelle pour une inscription en ligne générique des dispositifs médicaux
- France – ANSM : L’ANSM lance une consultation publique sur un projet de recommandations pour la cybersécurité des dispositifs médicaux – Point d’information
- France – HAS : Toutes nos publications par thèmes – Recommandations, médicaments, actes, dispositifs, …
- France – L’évaluation médico-économique des DM : état des lieux et enjeux
- France – Application du règlement européen relatif aux dispositifs médicaux : l’ANSM met en place une phase pilote pour la partie investigations cliniques – Point d’information
- France – Téléimagerie : guide de bonnes pratiques
- France – Des semelles connectées pour prédire le risque de chute chez des personnes âgées ostéoporotiques
- France – Industries de la santé et transformation numérique
- France – Départ et nominations
- France – Modalités de dépôt d’un dossier de demande d’évaluation d’acte professionnel
- France – HAS : Journée d’information des fabricants de dispositifs médicaux – 29 mai 2019
- France – France Bans Textured Breast Implants
- France – L’ANSM décide, de retirer du marché des implants mammaires macrotexturés et des implants mammaires à surface recouverte de polyuréthane, par mesure de précaution
- France – AFNOR : Projet de norme – Gestion du rapport bénéfice/risque PR XP S99-223
- France – ASSEMBLEE NATIONALE : Rapport d’information sur les DM
- France – Prévention des risques d’infection associés à l’utilisation des sondes d’échographie endocavitaire
- France – ANSM – Prolapsus pelviens et de l’incontinence urinaire : Point d’étape sur les actions de contrôle et surveillance en cours
- France – Modalités pratiques de dépôt d’un dossier auprès de la CNEDiMTS
- France – Évaluer les dispositifs médicaux connectés, y compris ceux faisant appel à l’intelligence artificielle
- France – Spécificités méthodologiques d’évaluation clinique des Dispositifs Médicaux Connectés
- France – Un projet basé sur l’IoT pour la prise en charge des patients à domicile
- France – Dispositifs médicaux : garantir leur sécurité et leur efficacité
- France – Un guide sur l’aptitude à l’utilisation des DM co-signé Cetim et Snitem
- France – Signature du Contrat stratégique de la filière « Industries et Technologies de Santé »
- France – Nouveau livret du SNITEM : la Personne chargée de veiller au respect de la réglementation
- France – Nouveau livret du SNITEM : le Fabricant
- France – Dispositifs médicaux : garantir leur sécurité et leur efficacité
- France – Prothèses capillaires et accessoires (HAS)
- France – Plus de marquage CE pour les implants mammaires texturés d’Allergan
- France – Face à une situation de plus en plus critique, la France lance un appel à candidatures d’organismes notifiés
- France – Grande Enquête Nationale sur les Dispositifs Médicaux et sur l’application du Règlement UE 2017/745 (RDM)
- France – L’enquête internationale « Implant Files » montre les « incroyables lacunes de la surveillance en France »
- France – Préservatif remboursé : la Sécu aurait-elle les bourses trop pleines ?
- France – Implants: ce que les nouvelles règles vont changer
- France – Premier préservatif remboursé par l’Assurance maladie
- France – Affaire Implant Files: le SNITEM communique
- France – Les dispositifs médicaux sont « une zone d’ombre et d’inquiétude », selon Agnès Buzyn
- France – « Cash Investigation » : le scandale sanitaire des prothèses vaginales
- France – Implants médicaux : le manque de contrôle dénoncé par un consortium de journalistes
- France – Cancers : « La balance bénéfice/risque est toujours favorable aux implants mammaires pour les femmes », rassure Agnès Buzyn
- France – Il est désormais possible d’imprimer des implants en PEEK
- France – Les objets connectés de santé : attention aux fausses promesses !
- France – Reste à Charge 0 ou 100 % santé : le projet de décret dévoilé
- Snitem – Application de diagnostic personnalisé pour le nouveau règlement européen
- France – Éval. techno santé : place de la qualité de vie
- France – Loi n° 2018-892 du 17 octobre 2018 relative à la désignation aléatoire des comités de protection des personnes
- France – La HAS accorde le Forfait Innovation au système WISE CRT, dispositif médical implantable de resynchronisation cardiaque
- France – Une nouvelle norme (ISO 14607) pour les implants mammaires
- France – Prothèses PIP : la Cour de cassation ordonne un nouveau procès pour le certificateur TÜV
- France – Cœur artificiel : la société Carmat ouvre sa première usine et vise une production de 500 prothèses par an
- France – Jugées dangereuses, 50% des machines pour le don de plasma ont été retirées en France
- France – HAS/CNEDiMTS : Contribution patients : nouvelle règle à compter du 01/08
- France – Le LNE filialise son activité GMed de certification médicale
- Catégorie : Europe
- Catégorie : Amériques
- Catégorie : Asie-Pacifique
- Catégorie : Découverte
- Catégorie : Cosmétiques
- Catégorie : France
- France – L’alcool de betterave bio français de Tereos obtient la certification COSMOS
- France – Présentation des informations relatives à la fin d’une recherche : Arrêté du 26 janvier 2021
- Webinar – REGLEMENTATION EUROPEENNE DES PRODUITS BIOCIDES
- Webinar : REGLEMENTATION EUROPEENNE DES PRODUITS COSMETIQUES
- France – Gel hydroalcoolique, gel pour les mains : quelle différence ?
- France – L’ANSM délivrera des certificats BPF aux fabricants souhaitant exporter des produits cosmétiques vers des pays tiers
- 2021 ! Année de l’espérance
- France – 60 Millions de Consommateurs relance la polémique sur les cosmétiques
- France – Nanomatériaux : Evaluation du dispositif national de déclaration R-Nano
- France – La FEBEA lance CLAIRE, une application innovante pour décrypter les ingrédients des Produits Cosmétiques
- France – Certificat de conformité aux bonnes pratiques de fabrication de produits cosmétiques (Décret n° 2020-1337 du 2 novembre 2020)
- France – COSMED : L’intelligence économique et stratégique des entreprises de la filière cosmétique
- INSTITUT SCIENTIS – Webinar : Réglementation européenne des produits biocides
- France – Délivrance des Certificats BPF par l’ANSM : Finalisation des Décrets !
- France – Produits Hydro-Alcooliques : écoulement des stocks report de l’échéance au 31 mars 2021
- France – La FEBEA dénonce la Méthodologie approximative de l’étude publiée par 60 Millions de Consommateurs et conteste ses Accusations
- France – Produits de protection solaire : Comment les choisir et les utiliser ?
- France – Produits Hydro-alcooliques : Évolution des mesures dérogatoires
- France – COVID 19 : Impact sur le calendrier des sujets réglementaires
- France – Solaires pour enfants : Où en est-on ?
- France – Solutions hydroalcooliques (SHA) et tolérance au soleil : le point par la Société Française de Dermatologie
- France – Perturbateurs endocriniens : La France s’associe à ses partenaires européens pour constituer la liste des substances reconnues comme telles
- France – Pharmaciens désirant fabriquer du gel hydro-alcoolique : avis de la douane
- France – Gels ou solutions hydro-alcooliques : avis de la douane
- France – Lignes directrices émises par la FEBEA : prévention COVID-19, distanciations et produits cosmétiques
- France – Etude du potentiel cancérogène du glyphosate : l’Anses annonce la sélection des équipes scientifiques retenues pour conduire les études toxicologiques complémentaires
- France – Biocides : Réactions cutanées et oculaires provoquées par des bracelets répulsifs contre les insectes
- France – Fausse Polémique sur les Gels et Solutions Hydro-Alcooliques
- France – Nouvel étiquetage des gels hydroalcooliques (Arrêté du 17 avril 2020 modifiant l’arrêté du 13 mars 2020)
- France – L’ANSM et la DGCCRF publient des recommandations à destination de l’industrie cosmétique pour une meilleure utilisation des allégations « sans »
- France – Arrêté du 10 avril 2020 relatif au prix maximum de vente des gels hydro-alcooliques
- France – Communication MEDEF COVID-19/Gel Hydroalcoolique
- Europe – ANSES : Intoxications liées à la désinfection et aux autres situations à risque
- France – Cosmétiques : à la recherche du « naturel »
- France – Conseils COSMED pour la mise sur le marché rapide d’un gel Hydro-Alcoolique conforme au Règlement Biocide
- France – Covid-19 : LVMH va fabriquer des gels hydro-alcooliques pour les hôpitaux
- France – Les formations de l’Institut SCIENTIS
- France – Quel regard sur les cabines de bronzage ?
- France – Hygiène : Des Français plus propres malgré des résistances
- France – La Cour des comptes recommande un renforcement de la cosmétovigilance
- France – Lingettes pour bébé : un nouvel étiquetage prévient des dangers d’un composant
- France – Formations Institut Scientis
- France – Dgccrf : Composition des cosmétiques : l’exigence d’une information claire des consommateurs
- France – La FEBEA Révèle Deux Etudes Inédites sur l’Impact Socio-Economique et sur l’Attractivité de la Cosmétique Française
- France – L’Anses recommande de restreindre les substances persulfates dans les produits capillaires
- France – La France domine le marché mondial de la beauté mais doit s’adapter
- France – Les produits cosmétiques non rincés contenant du phénoxyéthanol ne doivent pas être utilisés sur les fesses des enfants de 3 ans ou moins – Point d’Information
- France – Programme d’évaluation de la conformité des sites aux BPL de l’ANSM (médicaments à usage humain, produits cosmétiques et produits de tatouage) : mise à jour de la liste
- France – Formations Cosmétiques 2019
- France – FORMATION : Réglementation Européenne des Produits Biocides
- France – FORMATION EN LIGNE : Microbiologie des Produits Cosmétiques
- France – Livre Blanc « Que Contient Mon Produit Cosmétique ? »
- France – New app to help consumers avoid ‘undesirable or allergenic’ cosmetics ingredients
- France- Bronzage en institut : Les précautions d’usage de la DGCCRF
- France – Applications cosmétiques : La FEBEA pointe les insuffisances scientifiques
- France – INSTITUT SCIENTIS : Formations et Wébinaires 2019
- Europe – Projet de règlement Phenylene Bis-Diphenyltriazine
- France – Publicité & Langue Française
- France – Lumière bleue : L’industrie cosmétique cherche à consolider les bases scientifiques de ses revendications
- France – Applications cosmétiques: les industriels veulent plus de « rigueur scientifique »
- France – Nanoparticules : Quel est le sens de la plainte de l’UFC-Que Choisir ?
- France – WEBINAIRE Décryptage du microbiome : applications cosmétiques et biocides Mercredi 26-sept – 10h-11h
- France – Mise à jour : La liste des installations d’essai du programme d’évaluation de la conformité aux BPL de l’ANSM
- France – Mise sur le Marché Européen des Produits Cosmétiques-Généralités
- France – Les Français sceptiques quant à l’efficacité des compléments alimentaires beauté
- France – Silab met en évidence les modifications du microbiote des peaux caucasiennes âgées
- France – Le CED fait sa rentrée sur le vieillissement cutané
- France – La France va inventorier les substances nuisibles aux récifs coralliens
- Catégorie : Europe
- Europe – European Commission adds natural whole-hemp CBD to CosIng database
- Europe – Cruelty-free cosmetics: Are we getting closer to a global animal testing ban?
- Europe – OCTOCRYLENE : Preliminary opinion of SCCS/1627/21
- Europe – L’Oréal Perso lipstick device debuts under YSL
- Europe – Microplastics and digital services part of ‘intense regulatory change’ in 2021
- Europe – Cosmetic ingredient safety: SCCS closes comment period on endocrine disruptor and nano toxicity prelim opinions
- Europe – Tatouages et maquillages : Règlement 2020/2081 de la Commission du 14 décembre 2020
- Europe – Les allergènes, principale source de non-conformité des cosmétiques en Europe
- Europe – Chemicals: EU takes action for safer tattooing inks and permanent make-up
- Europe – New method for determination of polar N-nitrosamines in cosmetic products
- Europe – EDQM reports presence of allergenic fragrances in cosmetics sold as “perfume-free”
- Europe – EC stands by ECHA rulings for animal data on cosmetic ingredients under REACH
- Webinar – Règlementation Européenne des Produits Cosmétiques
- Europe – Règlement (UE) 2020/1682 modifiant l’annexe III du règlement (CE) no 1223/2009 relatif aux produits cosmétiques
- Europe – Mouthwash against SARS-CoV-2? Unilever’s ‘very promising’ prelim study opens door to more research
- Europe – Beauty majors sign joint statement claiming EU animal testing ban is ‘being undermined’ by ECHA
- Europe – SCCS : Opinion on Copper (nano) and Colloidal Copper (nano)
- Europe – SCCS : Opinion on Hydroxyapatite (nano)
- Europe – Latest: L’Oréal to launch AI Perso lipstick device first in Q1 2021
- Europe – Beauty business: Are you prepared for Brexit?
- Europe – Nanomaterials : Advice on the safety of nanomaterials used in cosmetic products published by the SCCS
- Europe – Dioxyde de titane : opinion finale du SCCS
- Europe – The big split: Preparing for the end of the Brexit transition period
- Europe – Green Deal: Commission adopts new Chemicals Strategy towards a toxic-free environment
- Europe – Skin creams, make-up and shampoos should be free from Pluralibacter
- Europe – SCCS : Request for a scientific advice on Methyl-N-methylanthranilate (CAS No. 85-91-6, EC No. 201-642-6)
- Europe – Règlement cosmétique européen (CE) n°1223/2009 : Le manuel relatif d’application mis à jour
- Europe – Scientific opinion on Methyl salicylate (methyl 2-hydroxybenzoate; CAS: 119-36-8; EC number: 204-317-7) used in cosmetic products
- Europe – Liens entre REACH et Règlement cosmétiques : essais sur les animaux
- Europe – Cosmetics Europe launches updated Charter and Guiding Principles on Responsible Advertising and Marketing Communications
- Europe – ECHA : Microplastics restriction
- Europe – Titanium dioxide safe? SCCS seeks comment for use in cosmetics
- Europe – Cosmetics testing: OCCL network
- Europe – Four new hazardous chemicals to be phased out
- Europe – Europe’s microplastics phase-out: SEAC draft opinion on restrictions open for consultation
- Europe – Coronavirus : gel hydroalcoolique et soleil ne font pas bon ménage
- Europe – Increased number of non-compliant (hand) disinfectants on the market according to several EU member States and the EC
- Europe – Industry poised to continue fight against ‘extremely disproportionate’ EU microplastics restriction
- Europe – Non-animal testing: ECHA report shows ‘significant uptick’ of in vitro chemical tests
- Europe – Exportation de produits hydro-alcooliques en Europe : Cosmed fait le point
- Europe – SCCS : Opinion on hair dye Indigofera tinctoria (C170) CAS 84775-63-3 – Submission III
- UK – Odore répond au Covid-19 et envisage le futur de la distribution des cosmétiques
- Europe – SCCS : Opinion on Zinc Pyrithione (ZPT) (CAS No 13463-41-7) – Submission III
- Europe – SCCS : Opinion on the safety of aluminium in cosmetic products – Submission II
- Europe – GELS HYDRO-ALCOOLIQUES : La Commission Européenne clarifie le statut des produits
- Europe – Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 : tattoo inks or permanent make-up
- Europe – Système d’alerte hebdomadaire pour les produits dangereux
- Europe – L’ECHA a lancé une consultation publique jusqu’au 05/06/2020 incluant des substances d’intérêt cosmétiques
- Europe – ECHA’s committees conclude on five restrictions
- Europe – Coronavirus : L’industrie cosmétique se mobilise face à l’urgence sanitaire
- Europe – Questions/ réponses sur l’encadrement des tarifs des gels hydroalcooliques
- Europe – SCCS publishes final opinion on dihydroxyacetone safety
- Europe – Circular cosmetics: ‘We are in a new era of transparency’
- Europe – Paraben-containing cosmetics in pregnancy linked to child obesity
- Europe – Animal testing declines across EU – cosmetics must ‘share good practice’, says charity
- Europe – European Commission publishes titanium dioxide classification
- Europe – Beauty labels: In-depth on ‘crucial’ regulations for cosmetic allergens
- Europe – Request for a scientific opinion on Octocrylene (CAS No 6197-30-4, EC No 228-250-8)
- Europe – Request for a scientific opinion on Propylparaben (CAS No 94-13-3, EC No 202-307-7)
- Europe – Publication de l’opinion SCCS Indigofera tinctoria, ingrédient de coloration capillaire
- Europe – BREXIT : nouvelle date de sortie… et nouvelle option pour la notification des produits cosmétiques
- Europe – Règlement (UE) 2019/1858 autorise l’utilisation un nouveau conservateur en cosmétique : Hydroxyethoxyphenyl butanone
- Europe – Commission publishes updated catalogue of nanomaterials used in cosmetics
- Europe – Étiquetage des fragrances allergisantes – des règles de l’UE renforcées
- Europe – What kind of testing is mandatory for cosmetic products in the EU?
- Europe – European Chemicals Agency: Tackling REACH incompliance ‘the priority’ for coming years
- Europe – REACH restrictions to watch: Microplastics, permanent make-up and cyclic siloxanes
- Europe – ‘A brand-new standard’: Cosmetics Consultants Europe to launch safety assessment course
- Europe – Get ready for new REACH requirements for nanomaterials
- Europe – Member States to evaluate 74 substances in 2020-2022
- Europe – La Commission européenne adopte la classification CMR 2 pour le dioxyde de titane
- Europe – Brexit ready? ‘Highly surprising’ number of cosmetics companies remain ‘completely unprepared’
- Europe – Cannabidol beauty in the EU: It’s ‘reasonably predictable’ inspections will increase
- Europe – Hemp oil vs. CBD for anti-inflammatory skin care: Study
- UK – BREXIT – ‘No Deal’ Contingency Planning
- Europe – Opinion On Allergy Alert Test (AAT) as a proof-of-concept study
- Europe – ‘Free from’ guidance should create level playing field in EU
- Europe – CBD skin care: EU study shows antioxidant promise for topical disease treatment
- Europe – EU ‘free from’ cosmetics claims technical document is guidance, not regulation
- Europe – In the face of Brexit? Harmonising EU cosmetics compliance remains the goal, says regulatory expert
- Europe – Information on Cosmetic Packaging Materials in the Context of the EU Cosmetics Regulation EC 1223/2009 (Recommandations pour l’évaluation des emballages cosmétiques)
- Europe – How genetic insights can personalise skin microbiome launches
- Europe – SCCS – Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)
- Europe – Règlement (UE) 2017/1410 de la Commission
- Europe – CBD and cosmetics in Austria: What is the legislative environment?
- Europe – How the New Free From Claims Impact the European Cosmetics Space
- Europe – Regulation change: the end of ‘free from’ claims for beauty and personal care?
- Europe – Le Règlement UE 2019/831 dit « Omnibus » est enfin publié !
- Europe – Allergies cutanées : restreindre les substances chimiques dans les textiles, cuirs, fourrures et peaux
- Europe – Protecting formulas: Making more with less
- Europe – Notification aux centres antipoison : ouverture du portail de déclaration des mélanges dangereux
- Europe – Publication du Glossaire des ingrédients : la version actualisée de Verif INCI est disponible
- Europe – Produits de blanchiment dentaire, l’EDQM signale des problèmes de non-conformité
- Europe – EU highlights concerns with Israel’s draft cosmetics regulation
- Europe – 5 top regulation and safety updates to know about
- Europe – SCCS – Final version of the Addendum to the scientific Opinion SCCS/1491/12 on the hair dye substance 2-Methoxy-methyl-p-phenylenediamine and its sulfate salt – COLIPA n° A160 – Submission II (use on eyelashes)
- Europe – SEAC concludes to restrict hazardous substances in tattoo inks
- Europe – Protecting consumers against endocrine disruptors – the BEUC letter
- Europe – 5 latest updates for regulation and safety in beauty: 2019
- Europe – No-deal Brexit : À quoi doit se préparer l’industrie des cosmétiques ?
- Europe – Nouveau glossaire des dénominations communes des ingrédients (INCI) (Projet de texte établi conformément au règlement cosmétique 1223/2009)
- Europe – Opinion SCCS/1491/12 on eyelashes
- UK – Emollient cream build-up in fabric can lead to fire deaths
- Europe – Public consultation launched on restricting substances in tattoo inks
- Europe – Règlement Européen sur les produits cosmétiques
- Europe – Rapport sur les Perturbateurs Endocriniens
- Europe – « Produits Cosmétiques » : mise à jour de l’ARPP
- Europe – EU publishes strategy on hormone disrupting chemicals
- Europe – 10ème révision du document « THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION »
- Europe – The Impact of a ‘No deal’ Brexit on the Cosmetics Industry
- Europe – Is vegan testing the latest step towards cruelty-free beauty?
- Europe – Cosmetics Business Regulatory Summit Day 1: From safety assessment to Brexit
- Europe – EU Scientific Committee publishes opinion on salicylic acid safety in cosmetics
- Europe – Dernière lettre d’information émise par le Service national d’assistance REACH-CLP
- Europe – The draft Commission Regulation aims at prohibiting the use of the substance 2-Chloro-p-Phenylenediamine
- Europe – SCCS : Opinion finale sur le modèle d’évaluation quantitative du risque de la sensibilisation cutanée due à un ingrédient de parfum (QRA 2)
- Europe – SCCS : opinion relative à la sécuritésubstance Phenylene Bis-Diphenyltriazine
- Europe – Le programme de stratégie scientifique à long terme de Cosmetics Europe
- Europe – Nouvelle version Consolidée du règlement cosmétique (CE) n°1223/2009 publiée le 01.08.2018
- UK – En Grande-Bretagne, les soins du visage plébiscités par les consommatrices
- Catégorie : International
- USA – Cosmetic Registration Reports
- USA – Formaldehyde in Hair Smoothing Products: What You Should Know
- Brazil – Brésil : L’Anvisa précise les nouvelles règles d’étiquetage des ingrédients
- USA – Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- USA – VCRP : Cosmetic Registration Reports
- Pakistan – Lack of cosmetic regulations in Pakistan despite prevalence of frequently contaminated products
- International – Exporter en Chine sans tests sur animaux ? La France dans les starting-blocks !
- China – China cosmetic registration: SAMR publishes full details of new rules that will be enforced in May
- China – China ready to allow use of nano and biotech materials in cosmetics for the first time
- USA – Voluntary Cosmetic Registration Program (VCRP) : December 2020
- Asia – The major cosmetics regulatory issues on the agenda for APAC in 2021
- WEBINAR – VACCINS ANTI-COVID De quoi parle-t-on ?
- USA – CBD: the beauty ingredient trend that can’t be stopped
- USA – OTC aux Etats-Unis : Comment choisir la bonne Voie Réglementaire
- Brazil – L’Anvisa modifie les règles d’étiquetage des cosmétiques
- USA – How is ‘natural’ regulated in the US?
- South Korea – K-beauty personalisation laws: MFDS brings into force rules for customised cosmetics retailers
- Indonesia – GMP in Indonesia: Regulator BPOM introduces ‘Gradual Fulfilment Certificate’ to enhance cosmetics manufacturing practices
- Asia – Covid-19 lasts on skin for 9 hours, but ethanol sanitiser inactivates in 15 seconds – Japan scientists
- USA – La Californie interdit plusieurs substances toxiques dans les cosmétiques
- USA – Cosmetic Registration Reports (VCRP)
- China – Chine : Aperçu des nouvelles réglementations cosmétiques
- Asia – Sunscreens containing salicylate UV-filters may be breeding ground for pathogenic bacteria
- USA – Cosmetic Registration Reports
- USA – FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
- China – Regulator publishes two more drafts detailing safety assessment and classification for cosmetic products
- International – L’Oréal files patent on ‘superior stability’ waterless sunscreen using carnauba wax
- International – Teeth whitening products: Regulations across the globe
- International – A guide on how to write cosmetics ingredient lists in EU, US and Canada
- China – New China regulations: Final CSAR rules revealed after delays caused by COVID-19
- International – CBD and transparency: Not all CBDs are the same
- Canada – Health Canada recalls unsafe hand sanitizer products
- Korea – Personalised policy: Korea MFDS details safety specifics for custom cosmetic manufacturers
- Philippines – Handy guide: Philippines FDA sets mandatory cosmetic labelling requirements for sanitisers
- Canada – How to make claims for cosmetics sold in Canada
- USA – FDA : Voluntary Cosmetic Registration Program (VCRP)
- USA – Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer
- USA – Regulatory Policy Information | Sunscreen Innovation Act
- China – Chine : refonte en vue du cadre réglementaire des cosmétiques
- USA – California’s Toxic-Free Cosmetics Act gets Assembly approval
- USA – J&J will stop selling talc-based Baby Powder in US and Canada
- China – Ban the bead: Cleansers, shampoos and toothpaste included in China’s latest draft on microbead ban
- USA – Voluntary Cosmetic Registration Program Report (VCRP) for April 2020
- USA – 16,000 Johnson & Johnson talc cases get the green light from Judge Wolfson ruling
- USA – Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns
- Canada – Health Canada loosens hand sanitizer ingredient regulations
- USA – CARES Act amends OTC monograph, updating sun care regulations
- USA – 19 ways the beauty industry is responding to CoronaVirus
- USA – The FDA talc report is here
- USA – Sequential Skin: beauty tech’s new approach to genetic analysis and microbiome skin care
- Asia – Skin science: Top five stories on cosmetics science and formulation
- Asia – Triple threat: Shiseido unveils ‘perfect’ sunscreen that strengthens with heat
- Asia – Don’t stop using sunscreen, even though chemicals ‘may seep into the bloodstream’
- Asia – Laws and regulation: Most-read stories on cosmetic regulation in APAC
- International – Des agents démêlants cationiques 100% biosourcés par Inolex Amino Lipids
- International – Révision et confirmation de la Norme ISO 17516 :2014
- USA – FDA calls meeting on standardization of talc testing methods
- USA – Black women who dye hair more at risk of breast cancer
- Asia – Western expansion? What APAC beauty brands need to know about testing before exporting to Europe and the US
- USA – Bayer to develop medical skin care from staphylococcus epidermidis bacteria strains
- China – China passes CSAR: Long-awaited cosmetic regulations draft finally formalised
- USA – Public Meeting on Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc
- Asia – Need-to-know: The top cosmetics regulatory issues on the agenda for APAC in 2020
- International – Unhygienic make-up bags are rife with superbugs, scientists warn
- USA – FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
- Asia – Top 10: Biggest stories on APAC cosmetics regulation in 2019
- USA – Selecting the right compliance reporting system
- USA – VCRP : Cosmetic Registration Reports – Novembre 2019
- Asia – Laws and regulation: Top news on cosmetics regulation across the APAC region
- China – China’s NMPA orders additional tests on cosmetic products containing sunscreen agent
- USA – Une proposition de loi pour définir les cosmétiques naturels
- USA – October Cosmetic Registration Reports (VCRP)
- Asia – ASEAN Cosmetics Directive: Decoding the regulation differences within the region
- China – China expansion? Ensuring formulas are compliant with ‘constantly changing’ cosmetic regulations
- Singapore – Education, not regulation: More cosmetic rules not the way to battle ‘free from’ claims – HSA
- Asia – ‘Time for cosmethics’: Why ISO standards are crucial for organic and natural transparency – CFTAS president
- USA – Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination
- USA – Voluntary Cosmetic Registration Program Report for September 2019.
- USA – What’s going on with CBD legislation for beauty?
- Canada – How to register your cosmetic products in Canada
- Jamaica – Jamaican authorities eye expansion into medical cannabis
- USA – VCRP Monthly Status Report : August 2019.
- Asia – Laws and regulation: Top news on cosmetics regulation across the APAC region
- Thailand – Cash crop: Thai authorities approve use of hemp in food, cosmetics and CBD in herbal products
- Australia – Australian regulatory guidelines for sunscreens (ARGS)
- Taiwan – The Cosmetic Hygiene And Safety Act Reshaped Taiwan’s Cosmetic Regulation
- Asia – Asbestos-containing cosmetics: Officials reveal products were manufactured in China, not Taiwan
- Asia – Laws & Regulation: Top news on cosmetics regulation across the APAC region
- Singapore – HSA Alert: Undeclared Potent Ingredients Found in Four Skin Creams; Infant Hospitalised with Serious Adverse Reaction
- USA – Voluntary Cosmetic Registration Program Report for June 2019
- International – Everything you always wanted to know about in vitro toxicology for cosmetics
- International – CTPA : “Guideline on Artificially Enhanced Nails and Minimising the Risk of Allergy”
- Australia – Inconsistent policies: Aussie researchers call for more harmonised sunscreen guidelines
- USA – CBD product makers should be mindful of FDA guidelines
- Asia – Changes, challenges and opportunities: ACA President on sustainability and regulation in APAC
- USA – Cosmetics Recalls & Alerts
- International – Ingredients players come up with smart solutions to CBD regulation.
- China – Chinese cosmetics regulation and key differences with the EU
- International – Examine all available evidence before making decisions on sunscreen ingredient bans.
- USA – Should we be worried that the chemicals from sunscreen can get into our blood?
- China – Chinese cosmetics regulation: how does it work?
- USA – VCRP Monthly Status Report
- USA – Tracking the sunscreen crackdown
- International – The impact of airborne pollution on skin
- USA – FDA issues final rule on safety and effectiveness of consumer hand sanitizers
- China – Animal testing ban still ‘unlikely’ even as China greenlights alternative processes for cosmetic ingredients
- USA – Time for a makeover-cosmetics regulation in the United States.
- USA – VCRP Monthly Status Report
- International – Le logiciel de l’INRS répondant aux besoins des utilisateurs de produits chimiques dans leur démarche de prévention du risque cutané
- International – Assessment of targeted non-intentionally added substances in cosmetics in contact with plastic packagings. Analytical and toxicological aspects
- International – Laws & Regulation: Top news on cosmetics regulation across the APAC region
- USA – Voluntary Cosmetic Registration Program Report for February 2019
- International – Les changements réglementaires à l’international
- International – Validation of an in vitro sun protection factor (SPF) method in blinded ring‐testing
- USA – FDA advances new proposed regulation to make sure that sunscreens are safe and effective
- Korea – Korea Requires Infant and Children Cosmetic Responsible Sales Managers to Establish Product Safety Data
- International – ‘Morning routine’: Sunscreen guidance revamped by safety bodies in Australia and New Zealand
- Vietnam – A Comprehensive Guide to Cosmetics Registration in Vietnam
- International – The future of in silico chemical safety … and beyond
- International – Réduction des coûts dans la gestion des produits chimiques
- International – Sun protection ‘oversimplification’? Researchers question current WHO guidelines
- International – Publication de la norme ISO 11930:2019 sur l’évaluation de la protection antimicrobienne d’un produit cosmétique
- China – Liste des ingrédients en Chine
- Philippines – Mercury in cosmetics: Philippine city introduces new rules to protect public
- Singapore – Skin-on-a-Chip: Singaporean scientists develop device which can replace animal-testing
- China – Exporting cosmetics to China just got a bit easier
- China – China officially replaces imported cosmetic registration with nationwide filing management
- International – L’Oréal Releases Sun Exposure Monitor Through Apple
- Asia – Laws & Regulation: Top news on cosmetics regulation across the APAC region
- USA – FDA Requests Comments on New Consumer Survey about Allergens in Cosmetics
- USA – FDA takes action to stop the use of lead acetate in hair dyes
- International – Extrapolation of in vitro structural alerts for mutagenicity to the in vivo endpoint
- International – Nouveau code de conduite pour l’industrie mondiale du marketing et de la publicité
- USA – VCRP Monthly Status Report
- International – Cosmétiques naturels et bios : La nouvelle norme ISO fait débat
- Brésil – L’ANVISA s’engage à simplifier la réglementation des cosmétiques pour enfants
- USA – VCRP Monthly Status Report
- International – Fragrance Material Safety Assessments
- USA – The Allergy Alert Test: Introduction of a Protocol Suitable to Provide an Alert Signal in p-Phenylenediamine–Allergic Hair Dye Users
- International – Gesturecare. Modeler votre beauté naturelle.
- International – What happened this summer?
- International – L’Afrique est-elle l’Asie du futur ?
- Study – Chemical stability and in chemico reactivity of 24 fragrance ingredients of concern for skin sensitization risk assessment
- Study – A multi-detector chromatographic approach for characterization and quantitation of botanical constituents to enable in silico safety assessments
- Afrique – L’Afrique, de plus en plus accro aux produits de blanchiment de la peau
- International – La Turquie impose des droits de douane de 60% sur les cosmétiques américains
- International – L’Oréal veut booster ses ventes sur Facebook avec des tests de maquillage en réalité augmentée
- Chine – Les cosmétiques séduisent la clientèle masculine
- Brésil – Beraca veut faciliter l’accès aux ingrédients issus de la biodiversité brésilienne
- International – Ingrédients synthétiques de parfumerie – Un juste retour de flamme
- Catégorie : France
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- France – Vaccination Covid-19: les PUI peuvent désormais faire remonter leurs stocks de DM nécessaires à l’injection
- USA – Collins vows to dismantle structural racism at NIH
- France – Fuite massive de données de santé: la Cnil dispense ses conseils aux patients concernés
- France – La Cnil cherche à accompagner des projets innovants dans la santé numérique
- France – Stratégie de vaccination contre le Sars-Cov-2 – Actualisation des facteurs de risque de formes graves de la Covid-19 et des recommandations sur la stratégie de priorisation des populations à vacciner
- International – Humidity from masks may lessen severity of COVID-19
- USA – FDA eases storage, transportation conditions for Pfizer-BioNTech vaccine
- France – Traitements par anticorps monoclonaux seront très prochainement disponibles en France
- USA – NIH study finds that people with SARS-CoV-2 antibodies may have a low risk of future infection
- UK – NHS gives women Human Papillomavirus Virus (HPV) home testing kits to cut cancer deaths
- France – Fuite des données de santé de près de 500.000 patients: le parquet de Paris ouvre une enquête
- International – WHO agrees to no-fault compensation for rare serious side effects from COVAX-distributed vaccines
- UK – First dose of Pfizer/BioNTech vaccine reduces COVID-19 infection risk by 70%
- France – Doctolib lance un module pour accompagner l’ouverture de la vaccination en ville
- Europe – Scandale des prothèses PIP : la cour d’appel d’Aix-en-Provence confirme la responsabilité du certificateur TÜV
- France – Sécurité informatique: 50.000 comptes utilisateurs d’établissements de santé français en vente sur internet (ACSS)
- Europe – AstraZeneca vaccine faces resistance in Europe after health workers suffer side-effects
- France – L’ANS dévoile les 30 projets retenus pour la construction du « store » de l’espace numérique de santé
- France – TousAntiCovid: un accès prioritaire aux tests pour les utilisateurs exposés et la possibilité d’enregistrer les lieux visités
- France – Plus de 400.000 données de patients français vendus dans le blackmarket
- International – Pourra-t-on détecter les épidémies grâce à l’intelligence artificielle ?
- International – La première intelligence artificielle capable de créer des génomes humains
- UK – UK to launch world-first COVID-19 human challenge study in the ‘next few weeks’
- UK – February interim findings from COVID-19 REACT-1 study published
- France – Le Fonds FHF lance le guide Hospi’Up pour faciliter la collaboration entre établissements et start-up
- International – South Africa wants to return 1 million AstraZeneca vaccine doses to Serum Institute: report
- USA – Study: 7 new coronavirus variants found in the US
- International – WHO: COVID-19 reinfection with new variants possible
- USA – US secures a further 100 million doses of Pfizer/BioNTech’s COVID-19 vaccine
- UK – AZ/Oxford University’s COVID-19 vaccine to be evaluated in children and young adults
- France – Endométriose: un outil numérique pour réduire le délai au diagnostic et optimiser le temps de consultation
- France – Symptômes prolongés suite à une Covid-19 de l’adulte – Diagnostic et prise en charge
- France – Outil d’aide au repérage précoce et intervention brève : alcool, cannabis, tabac chez l’adulte
- France – Une seule dose de vaccin pour les personnes ayant déjà été infectées par le SARS-CoV-2
- France – Méta-analyse de l’intérêt diagnostique des tests RT-PCR salivaires de détection du SARS-CoV-2
- France – Stratégie de vaccination contre le SARS-CoV-2 – Vaccination des personnes ayant un antécédent de Covid-19
- France – Vaccination : comment expliquer ces retards ?
- France – Pourquoi la France n’a-t-elle pas trouvé son vaccin contre la Covid-19 ?
- France – Le conseil de la Cnam s’oppose au transfert d’une copie du SNDS dans le Health Data Hub
- France – Publication d’une vaste étude réalisée sur 66 millions de personnes sur les facteurs de risque associés à l’hospitalisation et au décès pour Covid-19
- Europe – EU orders another 300 million doses of Pfizer/BioNTech’s COVID-19 vaccine
- France – Pharmagest prépare la vaccination anti-Covid en officine
- International – Covid : comment les vaccins s’adaptent aux variants ?
- UK – Clinical trial in hospitalized COVID-19 patients evaluates long-acting antibody therapy
- France – Le CHU de Rennes et Philips s’engagent dans un partenariat scientifique et d’innovation en santé
- France – Variants sud-africain et brésilien : Une note de la DGS diffusée en urgence pour renforcer la surveillance
- Europe – Il existe déjà près de 4 000 variants du coronavirus dans le monde, selon un ministre britannique
- International – Coronavirus : La théorie d’une fuite d’un laboratoire chinois jugée peu crédible par l’OMS
- India – Pfizer drops India vaccine application after regulator seeks local trial
- UK – COVID-19 antibodies ‘last at least six months’ in most people
- France – Dedalus dévoile Clinalytix, sa gamme d’IA pour l’aide à la décision médicale
- International – New analysis backs safety, efficacy of AZ/Oxford COVID-19 jab
- France – HAS : Place du vaccin d’ASTRA-ZENECA dans la stratégie de vaccination anti-COVID-19
- UK – UK vaccinations top nine million as concerns rise over South Africa variant
- France – AstraZeneca : la HAS recommande son utilisation chez les professionnels de santé et les personnes de 50 à 64 ans
- Australia – Investigation reveals no specific risk of COVID-19 vaccinations in elderly patients
- International – Novartis, Bayer announce separate agreements to bolster COVID-19 vaccine manufacturing
- International – Vaccination contre la grippe, il s’agit aussi de protéger le cœur
- UK – UK government secures additional 40 million doses of Valneva vaccine
- Europe – EU may restrict exports of some COVID-19 vaccines
- UK – UK will offer its genomic expertise worldwide to identify new COVID-19 variants
- International – Five or six doses? Controversy over Pfizer vaccine vials
- Europe – Décès post-vaccination dans plusieurs pays: ce que conclut l’agence européenne du médicament
- France – Vitamine D chez l’enfant : recourir aux médicaments et non aux compléments alimentaires pour prévenir le risque de surdosage
- France – Epilepsie: UCB crée Nile, une nouvelle « plateforme numérique » dotée de 25 millions d’euros
- France – Covid-19: la Cnil globalement satisfaite de la mise en oeuvre des systèmes d’information de traçage de l’épidémie
- International – Lasting immunity found after recovery from COVID-19
- USA – FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert
- France – Covid : le variant britannique pourrait être « l’équivalent d’une deuxième pandémie », craint Jean-François Delfraissy
- UK – UPDATED: Gilead says remdesivir likely to be effective against new COVID-19 strains
- Canada – Colchicine contre le Covid-19: un traitement qui suscite espoirs et doutes
- Belgique – Sunrise, la start-up belge qui veut faciliter le diagnostic de l’apnée du sommeil grâce à l’IA
- France – Covid-19: un décret crée la notion de personne « co-exposée »
- International – WHO may expedite approvals for several COVID-19 vaccines
- France – La Cnil publie un guide sur l’appariement de données avec le SNDS utilisant le NIR
- USA – Biden and biotech: Science first
- France – Mesure de la récupération de 5 complications post-opératoires
- USA – Moderna cooperating with investigation into possible COVID-19 vaccine allergic reactions
- International – E-cigarette pour les adolescents, pas sans risque pour les poumons
- France – IQSS 2019 – Méthode de validation du dispositif national de mesure de l’expérience et de la satisfaction des patients
- International – Covid 19 : l’agence norvégienne du médicament met en garde contre des effets possibles du vaccin Comirnaty chez les personnes âgées fragiles
- France – Mesure de la satisfaction et de l’expérience des patients hospitalisés + 48h en MCO (e-Satis +48h MCO)
- France – Mesure de la satisfaction et de l’expérience des patients hospitalisés pour une chirurgie ambulatoire (e-Satis MCOCA)
- Europe – PHE study finds people who have had COVID-19 can still transmit the virus
- France – Vaccin anti-Covid : six cas d’effets secondaires graves recensés par l’ANSM
- France – De nouvelles modifications de TousAntiCovid en préparation (projet de décret)
- India – Covid vaccine makers to be liable for adverse effects of jabs
- France – Vaccination: les pouvoirs publics choisissent Maiia, Doctolib et Keldoc pour la prise de rendez-vous
- France – Psychiatrie: des associations d’usagers alertent sur la collecte de données pour des fichiers de renseignement
- France – Replay de la conférence WHITE-TILLET « VACCINS anti-COVID : de quoi parle-t-on ? »
- France – Covid-19 : pourquoi la France a-t-elle commandé autant de doses de vaccins ?
- France – L’ex-ministre de la Santé Agnès Buzyn rejoint l’OMS
- France – Vaccin anti-COVID : première livraison de doses du vaccin Moderna annoncée lundi 11 janvier
- France – Stratégie de vaccination contre la Covid-19 – Place du Vaccin Moderna Covid-19 mRNA (nucleoside modified) dans la stratégie
- France – ANSM : Point de situation sur la surveillance des vaccins contre la COVID-19
- Europe – Covid-19. Des médicaments contre l’arthrite pourraient soigner la maladie
- France – Le vaccin Pfizer agit contre les nouvelles mutations Covid, selon un fabricant de médicaments
- France – Télésurveillance: les pouvoirs publics entament leur sprint final vers la généralisation
- France – Une expérimentation nationale de suivi à domicile des patients sous anticancéreux oraux autorisée
- France – L’assurance maladie a ouvert son téléservice « Vaccin Covid »
- India – Experts raise concerns over approval to Covid-19 vaccines
- France – L’homéopathie n’est désormais plus remboursée depuis le 1er janvier 2021
- France – Publication du décret sur le système d’information de suivi de la vaccination anti-Covid
- International – Covid-19 : comment fonctionnent les futurs vaccins
- International – Le groupe pharmaceutique chinois Sinopharm annonce que son vaccin contre le Covid-19 est efficace à plus de 79 %
- France – Vaccins anti-Covid-19 : un rapport sur les effets indésirables sera publié chaque semaine
- France – Un début « très lent » de la vaccination pour l’Académie de médecine
- 2021 ! Année de l’espérance
- India – AstraZeneca/Oxford vaccine: Five things to know about landmark UK vaccine
- France – Protection des données de santé: la Cnil sanctionne deux médecins libéraux pour manquements
- France – VACCIN anti-COVID : la position de la Société Française d’Infectiologie
- France – Pandémie, « tous dans le même bateau »
- China – Après le Covid-19, la Chine pourrait devenir plus vite la première économie mondiale
- France – Vaccination contre la Covid-19 : la HAS définit la stratégie d’utilisation du vaccin Comirnaty ®
- France – Covid-19: un projet de décret détaille le système d’information prévu pour le suivi de la vaccination
- France – Covid-19. La HAS rendra son avis jeudi matin sur le vaccin Pfizer-BioNTech
- International – Pfizer-BioNTech, Moderna Test Vaccines Against New Covid-19 Variant Spreading Across U.K.
- France – Covid-19: un projet de décret détaille le système d’information prévu pour le suivi de la vaccination
- France – Loi d’accélération et de simplification de l’action publique: les mesures concernant le numérique en santé
- International – Twitter va s’attaquer aux fake news sur les vaccins au Covid-19
- France – La DGS précise les chiffres relatifs à l’application TousAntiCovid
- WEBINAR – VACCINS ANTI-COVID De quoi parle-t-on ?
- UK – Key mutations found in new coronavirus strain in the UK
- France – Stratégie vaccinale contre la COVID : Les recommandations de la HAS
- France – Sexe, genre et santé
- France – L’Institut Curie s’associe à Ibex Medical Analytics pour améliorer la détection du cancer du sein grâce à l’IA
- France – Coronavirus : une nouvelle piste génétique pour expliquer les formes graves
- France – Health Data Hub: 3 projets d’établissements de santé autorisés par la Cnil
- UK – MHRA issues allergy warning for Pfizer/BioNTech COVID-19 jab
- International – WHO releases interim trial results on 4 COVID-19 drugs
- UK – World first as UK launches COVID-19 vaccination programme
- France – Covid-19: lancement de l’outil PredictEST pour la modélisation et l’aide à la décision dans le Grand Est
- International – Le Molnupiravir, un espoir pour stopper la transmission du Covid-19 ?
- France – Softway Medical interface son dossier patient informatisé avec Doctolib
- International – SARS-CoV-2 mink-associated variant strain – Denmark
- France – La stratégie vaccinale
- France – Présentation de la stratégie vaccinale du Gouvernement et des mesures de luttes contre la COVID-19 du 3 décembre 2020
- UK – Hospitals to start biggest ever NHS Vaccination Programme this week
- France – L’éditeur Dedalus victime d’une cyberattaque
- France – Alain Fischer, un grand scientifique pour conduire la campagne vaccinale
- France – Télémédecine: Qare clôt une année 2020 record avec près d’un million de téléconsultations
- France – TousAntiCovid: modification des critères de distance et de durée du contact
- UK – UK authorises Pfizer/BioNTech COVID-19 vaccine
- France – La France présente quelques unes de ses mesures innovantes pour lutter contre l’antibiorésistance
- France – Compléments alimentaires : des « médicaments » qui n’en sont pas….
- International – Covid-19 : reconnaître la maladie et évaluer sa gravité
- International – Évaluation des vaccins covid-19 : des questions à se poser
- France – L’ANS détaille l’avancée de ses projets d’interopérabilité des SI de santé
- Europe -NHS to pilot potentially revolutionary blood test that detects more than 50 cancers
- International – Les cigarettes électroniques peuvent-elles aider les gens à arrêter de fumer, et ont-elles des effets indésirables lorsqu’elles sont utilisées à cette fin ?
- International – L’Ecosse devient le premier pays à rendre les protections périodiques gratuites
- France – Officine: mise en ligne de données de ventes de tests antigéniques en open data
- France – Le Conseil d’Etat annule la suspension du Baclocur, médicament contre l’alcoolisme
- USA – US to start distributing Regeneron’s COVID-19 drug
- International – AstraZeneca/Oxford vaccine 90% effective in study
- Europe – Covid-19 : l’Agence européenne des médicaments pourrait autoriser un vaccin d’ici la fin de l’année
- France – L’interdiction du CBD en France jugée illégale par la justice européenne
- France – Amazon se lance dans la livraison de médicaments sur ordonnance aux Etats-Unis
- France – Le chiffre d’affaires de Pharmagest porté par ses acquisitions au troisième trimestre
- USA – Pfizer applies for emergency FDA approval of COVID-19 vaccine
- USA – Covid-19 : la FDA autorise le traitement de Regeneron administré à Donald Trump
- International – Covid-19 : l’OMS ne recommande pas le remdesivir
- France – Publication d’une ordonnance autorisant la généralisation de l’e-prescription
- France – Le HDI formule 9 recommandations pour mieux répondre aux crises sanitaires grâce aux données
- France – Programme Hop’EN: l’Anap publie un outil d’autodiagnostic du DMP et du DPI
- France – COVID-19: des interrogations persistantes autour de la réponse immunitaire
- France – Un projet d’ordonnance annonce une réorganisation des règles sur l’identification des acteurs des services numériques de santé : professionnels et usagers
- USA – Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
- USA – Covid : Moderna annonce un vaccin encore plus efficace que celui de Pfizer
- USA – Moderna preparing for interim analysis of late-stage COVID-19 vaccine data
- International – WHO in talks with Russian institute on Sputnik V COVID-19 vaccine
- Europe – SARS-Cov-2 variants in mink: rapid assessment published
- France – Covid-19. L’agence européenne des médicaments mise sur un vaccin distribué « à partir de janvier »
- France – L’Institut Pasteur de Lille sur la piste de suppositoires contre le Covid ?
- Russia – Russia says its Sputnik V COVID-19 vaccine is 92% effective
- France – Covid-19: l’Institut Pasteur de Lille espère rendre un médicament disponible « début 2021 »
- France – Un projet d’ordonnance organise l’identification électronique des professionnels de santé et des patients
- UK – UK study will evaluate aspirin as a potential COVID-19 treatment
- France – Dépakine. L’Agence du médicament mise en examen pour « homicides involontaires » (ANSM)
- USA – Ces sprays nasaux pourraient nous protéger du coronavirus
- USA – Biden announces new COVID-19 task force
- France – Covid-19 : les sociétés pharmaceutiques Pfizer et BioNTech annoncent que leur vaccin est « efficace à 90% »
- International – Covid-19 : L’efficacité d’un futur vaccin serait-elle menacée par les visons ?
- France – Didier Pittet, épidémiologiste et infectiologue : « Laisser mourir les vieux ou les confiner, ça n’a pas de sens »
- France – La Cnil formule de nombreuses critiques sur le projet de décret encadrant le Health Data Hub
- France – Contact tracing: la Cnam en difficulté face à « la progression très brutale du nombre de patients »
- International – J&J plans to test its COVID-19 vaccine in ages 12-18 soon
- France – La transmission virale par cas contact pourrait chuter de 37% si TousAntiCovid était adoptée par 30% des Français
- France – Covid-19: les personnes asymptotiques perdraient plus rapidement leurs anticorps
- UK – Covid-19: comment des volontaires au Royaume-Uni vont être délibérément infectés
- France – Entrée en vigueur de l’e-prescription au plus tard le 31 décembre 2024 (DSS)
- International – Russia submits COVID-19 vaccine to WHO for emergency use listing
- France – Téléconsultation: les médecins insatisfaits deux fois plus nombreux qu’en 2019 (sondage Odoxa)
- France – Produits du tabac et du vapotage : l’Anses publie un panorama inédit des produits vendus en France
- USA – Discrimination raciale en médecine ? How an Algorithm Blocked Kidney Transplants to Black Patients
- USA – NIH scientists discover key pathway in lysosomes that coronaviruses use to exit cells
- France – Covid-19 et télémédecine: les fédérations professionnelles ne veulent pas « laisser le soufflé retomber »
- China – La Chine n’attend pas la fin des essais pour commencer à vacciner
- France – Hydroxychloroquine : pourquoi l’Agence du médicament a refusé une utilisation plus large
- France – Covid : le recyclage des masques face à une montagne d’obstacles
- France – Vitrobio concocte un spray nasal qui protège de la maladie Covid-19
- France – Le cannabis thérapeutique sera prescrit sous 5 formes
- France – Grippe: 60% des pharmaciens en rupture de stock de vaccins
- France – Covid-19 : le ministère de la santé élargit l’autorisation des tests antigéniques
- France – Turbulences en vue pour l’hébergement des données?
- France – Covid-19: l’expérimentation « article 51 » sur la télésurveillance du diabète gestationnel élargie à 6.000 patientes
- Europe – Pays-Bas : premier cas au monde de décès après une réinfection au coronavirus
- France – La FHF demande un coup de pouce pour soutenir le développement des systèmes d’information et d’organisation populationnels
- France – Saint-Louis et Lariboisière (AP-HP) installent une plateforme de microbiologie automatisée munie d’IA
- France – La montre connectée Scanwatch de Withings utilisée pour la télésurveillance de patients Covid+
- France – Cybersécurité: 37% des vulnérabilités détectées posent un risque de divulgation d’informations
- France – Covid-19: les médecins généralistes « partagés sur la téléconsultation » (Drees)
- Europe – J&J signs deal with EU for 200 million COVID-19 vaccine doses
- France – PLFSS 2021: la prise en charge intégrale de la téléconsultation prolongée pendant 2 ans
- France – Vaccin contre la grippe. L’Académie de pharmacie réclame la priorité pour les personnes fragiles
- International – WHO’s director-general says COVID-19 vaccine may be available by year-end
- France – Covid-19: plus de 1,1 million de cas contacts tracés par l’assurance maladie
- France – la Cour des comptes appelle à une organisation des soins plus efficace et économe
- France – PLFSS 2021 : stupéfaction du Snitem qui réagit
- France – PLFSS : Projet de loi de finances pour 2021
- International – Coronavirus : comment voir la situation épidémique dans Google Maps ?
- International – Coronavirus : les nouvelles prévisions alarmantes de l’OMS
- France – L’exploitation des bases de données en vie réelle, nouveau casse-tête du régulateur?
- France – PsychoPharma.fr: l’application qui veut simplifier les prescriptions en psychiatrie
- France – Health Data Hub: le Conseil d’Etat rejette un nouveau référé s’opposant à la collecte de données Covid-19
- France – Traçage de l’épidémie: plus de 600.000 cas contacts identifiés grâce à Sidep et Contact Covid
- Europe – Covid-19 : L’Inserm à la tête d’un réseau de recherche clinique européen
- France – Coronavirus : l’Institut Pasteur de Lille sur la piste d’un médicament pour « début 2021 »
- France – Dépistage de la Covid-19 : l’Assurance Maladie condamne fermement toute pratique visant à faire payer aux patients un accès plus rapide aux tests PCR
- France – La Sécurité sociale va provisionner 4 milliards d’euros pour 2021 pour la lutte contre la Covid-19
- France – Covid-19 : les morts de l’immunité collective
- USA – FDA launches digital health center of excellence
- France – L’Agence du numérique en santé publie son rapport d’activité pour 2019
- USA – Fourth large-scale COVID-19 vaccine trial begins in the United States
- France – Livi propose des téléconsultations en psychiatrie
- France – Le ministère de la santé et 235 industriels signent une charte en faveur de l’e-santé
- France – La HAS publie une fiche sur les critères d’éligibilité du télésoin
- Europe – AstraZeneca, Roche et Takeda accompagnent le déploiement du chatbot « MemoQuest » de Calmedica
- Russia – Un médicament anti-Covid mis en vente dans les pharmacies russes
- France – Le niveau de maîtrise du digital des laboratoires jugé faible par leurs cadres
- France – Industriels et conformité: l’outil Convergence de l’ANS est disponible
- UK – Le Royaume-Uni veut réaliser 10 millions de tests par jour pour combattre l’épidémie de COVID-19
- Europe – Des milliers d’opposants aux mesures contre le coronavirus manifestent en Allemagne et en Pologne
- France – La COVID reconnue comme maladie professionnelle (décret n° 2020-1131 du 14/09/2020)
- France – DREES – Les dépenses de la santé en 2019 en France et perspectives internationales
- France – Le Conseil scientifique favorable au raccourcissement de l’isolement
- France – Pluriannualité du financement de la sécurité sociale : le Grand soir ou nouveau comité Théodule ?
- France -L’université Paris-Saclay crée un DU « Ethique du numérique en santé »
- Europe – Le collectivisme stimule les efforts pour réduire la propagation de COVID-19
- Europe – L’Agence européenne du médicament recommande la dexaméthasone pour le traitement de Covid-19
- International – AstraZeneca’s trial illnesses may not be due to COVID-19 shot
- UK – Surrogate father pigs, goats could improve food security
- USA – Trump says coronavirus vaccine could be weeks away
- USA – FDA shares comparative performance data for COVID-19 tests
- France – Covid-19: le test rapide avec un résultat en 30 minutes est autorisé
- UK – Regeneron’s antibody drug added to UK Recovery trial of COVID treatments
- France – Sanofi annonce la date de fabrication d’un vaccin contre le Covid-19
- France – Génétique: le CHU de Dijon s’équipe d’un outil d’IA pour analyser les caryotypes
- France – Le détail des données accessibles via le Health Data Hub (projet de décret)
- France – Pharmabest ouvre la plus grande pharmacie de Paris avec une superficie de 2050 m2
- France – Coronavirus. AstraZeneca suspend les essais de son vaccin après l’apparition d’un effet secondaire grave chez un participant
- International – Un algorithme utilisant le protéome pour prédire le risque de développer un trouble psychotique
- China – Chinese drug firm says thousands have been vaccinated for COVID-19 on an emergency use scheme
- France – Télémédecine: ce qu’il faut retenir de l’avenant n°8 à la convention médicale
- France – Télésuivi du cancer: Bayer France s’allie à DirectoSanté pour lancer Oncoscope
- International – Les premières doses du vaccin russe Spoutnik V sorties
- France – Le Pr Didier Raoult sera-t-il condamné à ne plus pouvoir exercer?
- France – StopCovid : Les réponses apportées par le ministère des Solidarités et de la Santé à la CNIL lui permettent de clore sa mise en demeure
- International – Covid-19 : enfin quelques informations sur le vaccin Spoutnik-V
- UK – Government delivers 250,000 clear face masks to support people with hearing loss
- France – Projet de décret relatif au traitement de données à caractère personnel
- Europe – Covid-19 : une initiative franco-allemande pour harmoniser les règles de déplacement en Europe
- International – COVID-19: situation internationale à la fin août
- UK – Corticosteroids boost survival rates for COVID-19 patients
- France – Télésanté: les négociations conventionnelles seront engagées « dès la fin de l’été »
- Europe – Roche plans to launch rapid COVID-19 antigen test later this month
- France – Un spray nasal anti coronavirus : la nouvelle découverte du CNRS pourrait bloquer le Covid-19
- Europe – Publication de trois nouveaux référentiels de conservation des données de santé
- Europe – Coronavirus : l’OMS ne juge pas nécessaire un « verrouillage » de l’Europe
- Europe – Coronavirus : comment nos voisins européens s’en sortent-ils ?
- Europe – Des chiens dressés à détecter l’odeur du COVID
- International – La polio officiellement éradiquée du continent africain, selon l’OMS
- Europe – AstraZeneca starts trial of COVID-19 antibody treatment
- International – Russia seeks collaboration with India for manufacturing Covid vaccine Sputnik V
- International – WHO says 172 countries are poised to participate in COVID-19 vaccine initiative
- Europe – EU concludes discussions with Moderna for COVID-19 vaccine
- USA – US FDA-approved ointment found to treat, kill viral infections including COVID-19
- USA – Pfizer plans COVID-19 vaccine testing in children
- USA – Administration mulls fast-tracking COVID-19 vaccine
- China – First coronavirus re-infection reported in Hong Kong
- International – WHO cautious on COVID-19 plasma as U.S. issues emergency authorization
- UK – COVID-19 vaccine ‘unlikely’ to be available this year, says UK’s chief medical officer
- International – Mutant coronavirus appears more infectious, less deadly
- France – Stratégie de vaccination contre le COVID 19 – Anticipation des scénarios possibles de vaccination et recommandations préliminaires sur les populations cibles
- International – Vaccine nationalism must be prevented, says WHO director-general
- France – Dangers de la Dépakine : l’Agence du médicament veut mieux informer les patientes
- Europe – Covid-19 : une société polonaise teste un médicament à base de plasma
- International – Russia produces first batch of COVID-19 vaccine
- USA – FDA urged to temporarily remove e-cigarettes from market
- USA – US pays $1.5bn for 100 million doses of Moderna’s COVID-19 vaccine
- International – WHO: Coronavirus unaffected by seasonal changes
- International – WHO says discussing new COVID-19 vaccine with Russia
- Europe – Gates Foundation backs $3 COVID-19 vaccine
- France – Levothyrox. L’ancienne formule finalement disponible jusqu’à fin 2021
- International – Global recovery could be faster if COVID vaccine made available to all: WHO chief
- USA – NIH clinical trial to test antibodies and other experimental therapeutics for mild and moderate COVID-19
- International – Coronavirus : la Russie promet des centaines de milliers de doses de vaccin dès 2020
- France – Scandale de la Dépakine : Le laboratoire français Sanofi mis en examen pour « homicides involontaires »
- France – SARS-CoV-2 : Un futur virus saisonnier ?
- France – Covid-19 : le masque peut désormais être imposé à l’extérieur localement, annonce Olivier Véran
- France – Covid-19 : l’Inserm sur tous les fronts
- France – La moitié de la population posséderait une immunité au Covid-19 pré-existante
- France – Doctolib victime d’un vol de données portant sur plus de 6000 rendez-vous
- France – Les tests PCR seront désormais remboursés, même sans ordonnance ni symptôme
- USA – Etats-Unis : la guerre des masques est déclarée