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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
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  • France – Le Leem lance un nouveau « 100 Questions sur le médicament »
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  • 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
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  • Europe – EMA : Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
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  • USA – FDA works with drugmakers on shortages
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  • USA – Statistical Approaches to Establishing Bioequivalence
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  • Australia – TGA begins virtual GMP inspections of domestic manufacturers
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  • 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
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  • 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
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  • Europe – Guidance for medicine developers and companies on COVID-19
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  • 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
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  • 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
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  • 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
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  • 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
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  • Europe – COVID-19: developers of medicines or vaccines to benefit from free scientific advice
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  • 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
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  • 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
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  • 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
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  • USA – ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications
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  • USA – FDA seeks ways to promote individualized therapies
  • Europe – Guideline on Good Pharmacovigilance Practices (GVP) Module VII – Explanatory Note
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  • 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
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  • USA – Guidance Snapshot Pilot
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  • USA – Guidance : Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
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  • 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
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  • 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
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  • Europe – ICH S5 (R3) guideline on reproductive toxicology
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  • 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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  • 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
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  • UK – MHRA, EMA issue guidelines on eve of Brexit
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  • UK – UK withdrawal from the EU on 31 January 2020
  • Europe – EU agencies seek to develop common standards for medicine ePI
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  • Europe – Brexit: Council adopts decision to conclude the withdrawal agreement
  • USA – 2020 CDER Draft and Revised Guidance: What’s Coming
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  • France – Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance
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  • 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
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  • 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
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  • USA – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act
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  • 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?
  • Europe – Consultation deadline for revised dosage form monographs and general chapters drawing near
  • 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
  • USA – FDA Updates its Thinking on Immunogenicity Studies for Insulin Biosimilars, Interchangeables
  • USA – FDA : Certificates of Confidentiality
  • Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
  • USA – FDA Releases 81 Product-Specific Guidances
  • Europe – Brexit Costs EMA Almost €60M in 2019
  • USA – Draft Guidance : Transdermal and Topical Delivery Systems – Product Development and Quality Considerations
  • Europe – Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet
  • Europe – EC Offers Help to Wholesalers on GDP Inspections
  • USA – Considerations in Demonstrating Interchangeability With a Reference Product
  • USA – Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act
  • USA – Nonproprietary Naming of Biological Products
  • USA – Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry
  • Europe – Ex ante publicity of a negotiated procedure EMA/2019/40/LD – Legal advice in relation to procurement matters and contracts under EU procurement and Dutch law
  • Pakistan – Pakistan’s DRAP Creates Guidelines on Conducting Clinical Trials
  • Europe – Duplicate marketing authorisations for biological medicinal products
  • USA – Labeling for Biosimilar Products
  • France – Update : Antimicrobial resistance
  • USA – Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry
  • Europe – Dutch authorities hand over final building to EMA in Amsterdam
  • Europe – EMA : Mid-year report 2019
  • Europe – EU Health Group Raises Concerns About Delays to Clinical Trial Portal and Database
  • UK – NICE ‘OK’ for Sativex in MS
  • Europe – IRIS guide to the Industry portal
  • Europe – EC Offers Further Clarity on Clinical Trial Regulation
  • Europe – Consultation publique de la Pharmacopée Européenne sur le chapitre général 2.4.20. Dosage des impuretés élémentaires
  • Europe – Clinical investigation of medicinal products for the treatment of gout
  • USA – Researchers Call on FDA to Rethink Guidance Allowing Use of Surrogate Outcomes
  • UK – NICE recommends Elmiron for bladder pain syndrome
  • TGA Creates Advertising Guidance for Providers of Cell and Tissue Products
  • New Zealand – New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels
  • USA – Experts Pitch FDA on Policies to Improve Drug Development
  • Europe – Regulators’ advice can make a difference for faster patient access to highly innovative therapies
  • 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
  • Europe – First vaccine to protect against Ebola
  • 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
    • Europe – EDQM and EC build on 10 years of co-operation to support a more sustainable blood supply and resilient blood sector
  • Catégorie : Amériques
    • USA – FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe
  • 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
    • Europe – Le Parlement Européen décide de reporter d’un an la date d’application du RDM
  • Catégorie : Amériques
    • USA – Will Medtech Rise to FDA’s Sterilization Challenge?
    • USA – US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes
    • USA – FDA Updates 1989 Policies on Diagnostic X-Rays as Electronic Products
  • Catégorie : Asie-Pacifique
  • Catégorie : Découverte
    • USA – How a Brain-Computer Interface Could Help Paralyzed Veterans at Home
• 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 : Santé Publique
  • 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