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  • France – Martine Wonner suspendue pour un an par l’ordre des médecins
  • UK – ICR calls for further discussions following NICE’s rejection of breast cancer drug
  • Europe – IA: la Commission européenne renforce l’exigence de garantie humaine
  • UK – NICE recommends Janssen’s treatment for active psoriatic arthritis
  • Europe – Commission seeks 5-year extension MDR/IVDR delegated acts powers
  • USA – US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions
  • UK – Evusheld approved to prevent COVID-19 in people whose immune response is poor
  • USA – FDA offers guidance on patient-focused product development
  • Europe – MEPs call for a more effective EU strategy to beat cancer
  • USA – CES 2022: focus sur quatre entreprises en santé lauréates des « Innovation Awards »
  • UK – NICE pens two-year collaboration with the Academic Health Science Network
  • France – Health Data Hub: le ministère de la santé et la Cada refusent la publication des codes sources
• Catégorie : Médicaments
  • USA – FDA finalizes guidance on adjusting for covariates in randomized trials
  • USA – FDA proposes long-awaited patient medication information rule
  • Europe – Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
  • Europe – EU regulator recommends revoking approval for Novartis’ sickle cell disease drug
  • USA – FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies
  • USA – FDA drafts guidance on using ‘generally accepted’ knowledge to support drug approvals
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023
  • Europe – EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo
  • UK – SKYCovion COVID-19 vaccine authorised by MHRA
  • UK – MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
  • USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
  • UK – Regulatory approval of Pfizer/BioNTech vaccine for COVID-19
  • USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
  • UK – Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cance
  • USA – Dual draft guidances outline FDA vision for pediatric drug development, exclusivity
  • UK – AstraZeneca’s heart failure treatment recommended by NICE for expanded use
  • UK – MSD and Eisai’s combination therapy recommended by NICE for advanced endometrial cancer
  • UK – AbbVie’s Rinvoq recommended by NICE for Crohn’s disease
  • Europe – Guidance for industry to prevent and mitigate medicine shortages
  • France – Topiramate et risques chez les enfants exposés pendant la grossesse : modification des conditions de prescription et de délivrance aux femmes concernées
  • Europe – EMA annual report 2022 published
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12 May 2023
  • Europe – Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects
  • UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
  • USA – FDA wants feedback on testing methods for new nitrosamines
  • UK – Otsuka’s Lupkynis receives NICE green light
  • Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
  • Canada – Guidance : Nitrosamine impurities in medications
  • USA – FDA issues draft guidance on decentralized clinical trials
  • Europe – GSK’s RSV vaccine candidate recommended by CHMP for older adults
  • Europe – European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines
  • UK – NICE approval for Janssen’s Darzalex combination
  • UK – Kite’s CAR-T therapies recommended by NICE for certain blood cancers
  • USA – FDA issues final guidance on nicotine replacement therapy
  • USA – MedCon: TAP pilot off the ground four devices enrolled
  • USA – FDA officials offer CMC advice for gene therapies at OTP town hall
  • UK – Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia
  • Europe – Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
  • USA – Authorisation for Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines simplified by FDA
  • USA – FDA draft guidance aims to help sponsors develop drugs for radiation exposure
  • USA – FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
  • USA – Global regulators discuss how they are adapting to AI, real-world data in drug and food safety
  • USA – FDA to require new safety warnings for opioids
  • UK – AstraZeneca’s Lynparza recommended by NICE for breast and prostate cancer
  • USA – FDA updates generic transdermal and topical delivery systems guidances
  • USA – FDA outlines risk-based approach to monitoring clinical trials
  • USA – FDA updates guidance on reporting manufacturing disruptions for finished products and APIs
  • USA – FDA withdraws pre-term birth drug Makena
  • USA – FDA issues last guidance in patient-focused drug development series
  • UK – Ipsen reacts to NICE’s Cabometyx verdict
  • Europe – New features further strengthen Priority Medicines scheme (PRIME)
  • Europe – EU recommendations for 2023-2024 seasonal flu vaccine composition
  • USA – Guidance details review process for pediatric research not approvable by an IRB
  • USA – FDA to require mail-back envelopes for unused opioids
  • Europe – EMA recommends approval of Bimervax as a COVID-19 booster vaccine
  • UK – AstraZeneca and Amgen’s Tezspire recommended by NICE for severe asthma
  • USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray
  • USA – QMSR: Start now to be ready for final rule, slated for December
  • Europe – DARWIN EU® has completed its first studies and is calling for new data partners
  • USA – FDA encourages RCTs in accelerated approval guidance for oncology
  • UK – NICE sees ‘promise’ in four UTI tests that could help in fight against AMR
  • UK – Recommendation from NICE for PTC Therapeutics gene therapy
  • USA – NCI official raises concerns about FDA’s cancer drug dose optimization guidance
  • USA – FDA issues guidance on submission of pharmacogenomic data
  • UK – MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
  • UK – MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
  • USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
  • France – Risque de méningiome et progestatifs : recommandations générales pour limiter ce risque
  • USA – Industry requests more information from FDA on dosage and administration labeling
  • USA – FDA finalizes guidance on suspect products under DSCSA
  • USA – FDA issues guidance on developing long-acting local anesthetics
  • UK – NICE approves funding for Novartis gene therapy
  • USA – Pharma wants FDA’s IND reporting rule better aligned with ICH E2F
  • USA – FDA revises guidance on electronic systems and signatures in clinical trials
  • USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
  • USA – FDA warns pharmacy benefit company for distributing unapproved foreign drugs
  • UK – Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary measure
  • USA – FDA approves first treatment for Rett Syndrome
  • USA – Pfizer: le spray nasal anti-migraine approuvé par la FDA
  • Europe – EMA Q&A addresses submission of data elements for raw data pilot
  • USA – Generic drugmakers seek clarity on pre-submission facility correspondence
  • Europe – Regulatory, industry panels address EU GMP Annex 1 implementation
  • UK – Novo Nordisk’s weight-loss drug recommended by NICE
  • Europe – New agreement places Northern Ireland regulation back in the UK
  • USA – FDA seeks feedback on artificial intelligence in drug manufacturing
  • USA – FDA issues guidance on drug development for neovascular age-related AMD
  • Europe – EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
  • USA – Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal
  • Europe – EMA pilots scientific advice for certain high-risk medical devices
  • USA – Legal expert: FDA inspections will start looking at DSCSA compliance
  • USA – FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
  • UK – MHRA safety review of medicines containing pseudoephedrine
  • Europe – European Commission grants AstraZeneca three new approvals
  • USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
  • UK – NICE publishes final draft guidance recommending three COVID-19 treatments
  • USA – Guidance: FDA details ANDA PSG meetings under GDUFA III
  • UK – AstraZeneca’s Evusheld not recommended by NICE for COVID-19 prevention
  • Europe – Human medicines: highlights of 2022
  • USA – Study: One-fifth of recent FDA approved drugs not authorized, reimbursed in other countries
  • USA – Study: Extrapolation used in more than half of pediatric drug labeling changes
  • USA – Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9 February 2023
  • USA – FDA outlines criteria for conducting long-term neurodevelopmental safety studies in neonates
  • UK – NICE fails to recommend Boehringer Ingelheim and Lilly Alliance’s empagliflozin
  • USA – FDA officials offer advice on gene therapy trials
  • USA – DSCSA: New interoperability ‘blueprint’ released
  • Europe – Actions to support the development of medicines for children
  • Europe – Public consultation on a multi-stakeholder platform to improve clinical trials in the EU
  • USA – FDA releases FY 2022 generic drug research summary
  • USA – FDA draft guidance addresses clinical development of drugs to treat early Lyme disease
  • USA – FDA draft guidance addresses use of external controls to assess effectiveness of new drugs and biologics
  • UK – Roche’s Polivy recommended by NICE for lymphoma therapy
  • USA – FDA issues draft guidance on developing drugs for acromegaly
  • USA – Experts offer CTIS advice on eve of transition for new applications
  • UK – Gilead’s CAR-T cell therapy recommended by NICE for lymphoma
  • UK – NICE recommends Alexion’s asfotase alfa across England
  • USA – FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy
  • Europe – Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications
  • Europe – EMA update on shortages of antibiotics in the EU
  • UK – UK to introduce new regulatory framework for point of care manufacturing
  • UK – European Commission Decision Reliance Procedure (ECDRP) extension
  • USA – FDA finalizes guidance on cannabis clinical research
  • USA – FDA officials impart lessons learned from quality management maturity pilots
  • UK – NICE recommends Takeda’s Ninlaro triplet regimen
  • UK – NICE recommends PTC Therapeutics’ Translarna reimbursement
  • USA – FDA issues draft guidance on mpox drug development
  • UK – Amvuttra recommended by NICE for amyloidosis
  • USA – FDA details approach for finding optimal dosages for new cancer drugs
  • USA – FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine
  • UK – NICE recommends wider use of statins to cut risk of heart attack and stroke
  • USA – Omnibus brings new advanced manufacturing programs to FDA
  • USA – CERSI Summit: Wider use of real-world evidence continues to face hurdles
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12 January 2023
  • USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
  • USA – CDER chief: Improving clinical trials is on to-do list
  • International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
  • USA – Drugmakers, advocacy groups ask FDA to clarify expanded access draft guidance
  • USA – Provider groups, researchers raise concerns about extrapolating adult data in children
  • USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
  • France – La HAS actualise la doctrine vaccinale de lutte contre les orthopoxvirus
  • France – Avis de sécurité des Hospices civils de Lyon sur le LAP Easily
  • USA – FDA finalizes guidance on REMS format and content
  • USA – FDA’s drug approvals in 2022
  • France – Evaluer le circuit des Médicaments de thérapie Innovante (MTI)
  • France – L’ANSM renforce l’information des patients et des pharmaciens sur les risques liés aux vasoconstricteurs
  • USA – FDA draft guidance on controlled correspondence reflects GDUFA III commitments
  • UK – AstraZeneca/Daiichi Sankyo’s Enhertu recommended by NICE for advanced breast cancer
  • UK – Sanofi Pasteur COVID-19 vaccine authorised by MHRA
  • UK – Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment recommended by NICE
  • France – Accès précoce: des efforts restent à faire pour améliorer le recueil de données
  • Europe – Facilitating Decentralised Clinical Trials in the EU
  • USA – FDA revises guidance on responding to ANDA complete response letters
  • USA – FDA issues draft guidance on pulmonary tuberculosis drugs
  • Europe – EMA recommendation paper: Safety, data integrity key to decentralized trial conduct
  • Europe – First gene therapy to treat haemophilia B
  • USA – Experts: Give FDA authority to remove ineffective drugs
  • USA – NIH aims to reduce reputation bias in grant reviews
  • France – Pénurie d’amoxicilline : les recommandations de l’ANSM pour une utilisation rationnelle
  • USA – Industry asks FDA to harmonize pediatric study pharmacology guidance with ICH
  • UK – Kidney Research UK concerned by NICE process
  • Europe – ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2
  • USA – FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors
  • Europe – ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies
  • Europe – ETF statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants of concern
  • USA – Using mRNA technology for a universal flu vaccine
  • Europe – ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
  • USA – Uptake of biosimilars on the rise in the US, but number of marketed products lags other countries
  • USA – FDA updates statistical approaches for assessing bioequivalence
  • USA – FDA revises ANDA facility correspondence draft guidance
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November – 1 December 2022
  • Europe – EMA recommends withdrawal of pholcodine medicines from EU market
  • Europe – Respiratory vaccination candidate tested in German hospitals
  • USA – Industry groups seek changes to nonprescription drug access proposal
  • Singapore – Singapore’s HSA finalizes LDT guidelines
  • International – mRNA revolutionized the race for a Covid-19 vaccine. Could cancer be next?
  • USA – FDA issues pharmacy compounding guidance due to amoxicillin shortage
  • USA – FDA finalizes enforcement policy for FMT treatments
  • UK – NHS fast tracks life-extending prostate cancer drug to patients
  • UK – Bristol Myers Squibb’s Opdivo recommended by NICE for rare gastroesophageal cancers
  • USA – mRNA technology for universal flu vaccine shows early promise in US study
  • Europe – AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment
  • Europe – DARWIN EU® welcomes first data partners
  • USA – FDA’s top 10 tips to transition your COVID-19 products
  • USA – FDA releases guidance on compounding beta-lactam products in shortage
  • USA – FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
  • USA – Industry asks FDA to align quantitative labeling guidance with other regulators
  • Europe – EMA offers insights on when biologics qualify as new active substances
  • Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation
  • USA – Most FDA warning letters this year from onsite inspections
  • Europe – Best practices to fight antimicrobial resistance
  • UK – NICE recommends Sobi’s Doptelet to treat thrombocytopenia
  • UK – Kidney Cancer UK receives commission from NICE
  • USA – FDA approves first drug to delay onset of type 1 diabetes
  • UK – NICE recommends Pfizer’s Paxlovid on NHS
  • UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
  • USA – FDA relaxes EUA advertising limitation for some COVID drugs
  • UK – Research provides hope for patients with neurodegenerative disease
  • UK – NICE publishes draft guidance recommending three COVID-19 treatments
  • USA – FDA Adds/Revises Product-Specific Guidances
  • USA – Stakeholders ask FDA to harmonize adverse events terms with standards orgs
  • Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity
  • UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
  • USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
  • USA – FDA takes first step to allow low-dose OTC naloxone on market
  • USA – Biosimilar facilities usually get onsite inspections
  • Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
  • Europe – New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
  • Europe – EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
  • Europe – EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
  • UK – Ipsen’s cabozantinib receives NICE approval for advanced hepatocellular carcinoma
  • USA – FDA drafts guidance on ‘sameness’ evaluations for generic drugs
  • USA – FDA Says Face-to-Face Meetings Include Virtual
  • UK – Merck’s Keytruda receives NICE recommendation as breast cancer treatment option
  • UK – MHRA updates biosimilar guidance to allow interchangeability between products
  • Europe – Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs
  • International – ICH E11A: Pharma groups want more information on data extrapolation, pediatric biomarkers
  • USA – FDA finalizes umbrella trial guidance for cell and gene therapies
  • UK – Digital cognitive behaviour therapies recommended by NICE across the NHS
  • Europe – Regulatory update – EMA encourages companies to submit type I variations for 2022 by end of November
  • USA – FDA updates guidance on expanded access for investigational drugs under IND
  • USA – FDA announces CMC review pilot for drugs with expedited development
  • Europe – EMA grants AZ’s Vaxzevria COVID-19 vaccine full marketing authorisation
  • USA – FDA draft guidance aims to ensure accurate measurements of pediatric growth
  • USA – FDA releases draft guidance to spur development of CDI drugs
  • Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
  • Europe – EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
  • USA – Accès précoce et compassionnel: mise en oeuvre de l’authentification unique pour le recueil de données
  • USA – FDA releases new draft guidances on topical generic drugs
  • USA – FDA finalizes neurodegenerative disease gene therapy guidance
  • USA – FDA issues 80 guidances for topical products
  • USA – FDA finalizes multiple endpoints guidance
  • USA – Generic manufacturers call for changes to list of major deficiencies
  • USA – FDA starts PDUFA VII programs for real-world evidence, innovative trial designs
  • Europe – EMA recommends approval of second adapted Spikevax vaccine
  • Europe – EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
  • UK – Grifols’ Tavlesse receives NICE recommendation
  • USA – Pharma industry making some headway in DSCSA implementation
  • USA – Comparability protocols: Final guidance incorporates ICH Q12, allows for API supplier changes
  • USA – FDA issues final guidance on AML drug development, two oncology draft guidances
  • USA – FDA addresses alternative inspection tools, expectations for nitrosamine assessments in updated CPGs
  • Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde contre des risques graves rénaux et gastro-intestinaux
  • USA – FDA releases discussion paper on distributed and point-of-care manufacturing
  • Europe – New vaccine to protect people in the EU and worldwide against dengue
  • Europe – First therapy to treat transplant patients with post-transplant lymphoproliferative disease
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
  • USA – FDA expands bivalent COVID boosters to kids as young as 5
  • Europe – Data Quality Framework for EU medicines regulation
  • France – Monkeypox : la HAS complète ses recommandations sur la vaccination
  • France – La HAS publie le référentiel de certification des logiciels d’aide à la dispensation de PUI
  • USA – Experts call for federal incentives to promote clinical trial diversity
  • Europe – High-quality data to empower data-driven medicines regulation in the European Union
  • USA – Sentinel System expands capacity, data linkages, report indicates
  • Europe – EMA Management Board: highlights of October 2022 meeting
  • UK – Bristol Myers Squibb’s active ulcerative colitis treatment bags NICE recommendation
  • USA – FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III
  • France – Certification des logiciels d’aide à la dispensation (LAD) de pharmacie à usage intérieur (PUI)
  • USA – FDA issues guidances on facility readiness and early DMF assessments under GDUFA III
  • USA – FDA offers details on PDUFA VII STAR review pilot
  • USA – FDA warns that emerging Omicron subvariant could make Evusheld obsolete
  • USA – OIG raises concerns about accelerated approval pathway
  • UK – European Commission Decision Reliance Procedure (EC DRP) extension
  • USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
  • Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
  • Europe – EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
  • USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies
  • USA – FDA seek to harmonize human subject protections with revised Common Rule
  • USA – New FDA guidance offers ethical roadmap for including children in clinical trials
  • USA – Califf: FDA committed to boosting complex generic drug development
  • USA – Prenatal cannabis exposure associated with mental disorders in children that persist into early adolescence
  • UK – MSD’s pembrolizumab therapy gets NICE approval
  • International – Genetically modified herpes combats advanced cancers
  • Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants
  • Europe – Biosimilar medicines can be interchanged
  • Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection
  • Europe – EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
  • USA – FDA issues final rule on ‘right to try’ reporting requirements
  • USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
  • India – Indian Pharmacopoeia joins global discussion group pilot
  • USA – FDA issues guidance documents on labeling drug identity, constituents
  • USA – FDA finalizes guidance on submitting RWD/RWE in application cover letters
  • France – ANSM : Pholcodine : Suspension des autorisations de mise sur le marché et retrait de toutes les boîtes de sirop contenant de la pholcodine en raison d’un risque d’allergie croisée avec les curares
  • Europe – Annex 1 implementation strategies: Experts say manufacturers must grapple with PUPSIT
  • Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
  • UK – MHRA launches new conflicts of interest code of practice for independent advisors
  • USA – Groups weigh in on FDA’s licensing rules for 3PLs and distributors
  • USA – Industry experts tout potential for master protocols in pediatric clinical trials
  • USA – FDA issues emergency guidance to spur development of monkeypox tests
  • USA – FDA drafts guidance on pediatric clinical pharmacology studies
  • Europe – COVID-19 vaccines safety update
  • UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment
  • Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for control of bacterial endotoxins in its water monographs
  • Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products
  • Europe – New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European Pharmacopoeia
  • Europe – 11th edition of the European Pharmacopoeia now available in print
  • Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
  • UK – Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE
  • France – HAS : Covid-19 – un avis global sur les vaccins bivalents mi-septembre
  • USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
  • Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
  • USA – House report finds Trump officials sought to influence FDA during COVID pandemic
  • USA – FDA allows sponsors to spread out costs in revised IND charging guidance
  • USA – FDA approves durvalumab for locally advanced or metastatic biliary tract cancer
  • Europe – New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone
  • Europe – Review of pholcodine medicines started
  • Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing potential
  • Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
  • USA – FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines
  • Europe – EU issues long-awaited GMP Annex 1 revision
  • Europe – Patient registries: EMA officials highlight opportunities in orphan drug development
  • Europe – EMA accepts application for leukaemia drug from Otsuka and Astex
  • USA – European, US guidance differs on API nitrosamines
  • Asia – 3D-printed drug advancing to clinical trials in SE Asia
  • USA – Patients with incurable cancer should be included in trials for new therapies
  • USA – FDA issues final guidance on ANDA CRL, Orange Book
  • USA – FDA final guidance targets neonatal pharmacology studies
  • Europe – EMA reviewing data on sabizabulin for COVID-19
  • USA – FDA guidance focuses on Real-Time Oncology Review program
  • USA – FDA describes plans to expand remote regulatory assessments
  • Europe – EMA recommends restricting use of cancer medicine Rubraca
  • Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
  • USA – FDA offers new guidance on therapeutic equivalence evaluations
  • USA – FDA guidance targets dose banding information in drug labels
  • Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
  • Europe – Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
  • Europe – ICH Guideline M12 on drug interaction studies
  • UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark MHRA reclassification
  • USA – Industry asks FDA to expand scope of product quality assessment guidance
  • France – HAS : Agrément des Bases de données sur les Médicaments
  • UK – NICE recommends Rhythm Pharmaceuticals’ Imcivree for severe obesity and hyperphagia
  • USA – Legislation could catalyze EU pharma industry innovation
  • Europe – EC authorisation granted to kidney disease treatment Kinpeygo
  • Europe – EMA validates application for Byondis’ trastuzumab duocarmazine
  • UK – Bristol Myers Squibb’s Opdivo recommended by NICE for malignant pleural mesothelioma patients
  • UK – NICE recommends Novartis’ Piqray in combination with Faslodex for advanced breast cancer patients
  • Europe – EMA re-elected as chair of ICMRA from October 2022
  • USA – Guidance : Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products
  • USA – HHS issues guidance on legally prescribed drugs for abortion
  • France – La HAS recommande la vaccination des nourrissons contre les infections à rotavirus
  • Europe – EMA launches pilot project on analysis of raw data from clinical trials
  • Europe – ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
  • Europe – Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
  • Europe – Further measures to identify and address medicine shortages during public health emergencies adopted
  • Uk – NICE recommend’s use of Leo Pharma’s Adtralza
  • Italy – The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
  • Europe – Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
  • USA – FDA offers guidance on fit-for-purpose clinical outcome assessments
  • France – Rapport d’activité 2021 de la HAS
  • Europe – Global regulators agree on key principles on adapting vaccines to tackle virus variants
  • UK – NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia
  • Europe – EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate
  • UK – NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis
  • France – Topiramate : risque de troubles neurodéveloppementaux chez les enfants exposés in utero et rappel des règles d’utilisation chez les femmes
  • Europe – Possible use of the vaccine Jynneos against infection by monkeypox virus
  • Europe – Monkeypox: EMA starts review for Imvanex
  • USA – FDA releases 5-year action plan to combat neurodegenerative diseases
  • USA – FDA explains when it will rescind breakthrough designations
  • Europe – First gene therapy to treat severe haemophilia A
  • Europe – EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
  • Europe – EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
  • UK – NICE opts to reject Acorda’s MS drug Fampyra
  • USA – Draft guidance outlines FDA’s testing requirements for tissue containment systems
  • USA – Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver
  • USA – FDA to form task force, public-private partnership on rare neurodegenerative diseases
  • Europe – Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
  • Europe – EMA Management Board: highlights of June 2022 meeting
  • USA – FDA authorizes Pfizer, Moderna vaccines for youngest children
  • Europe – Start of rolling review for adapted Spikevax COVID-19 vaccine
  • UK – NICE recommends Eli Lilly’s breast cancer therapy
  • UK – Genedrive genetic variant test for infants evaluated by NICE
  • UK – MHRA joins international partnerships to set global standards for medicines and medical devices regulation
  • Europe – Start of rolling review for adapted Comirnaty COVID-19 vaccine
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022
  • Europe – EMA recommends withdrawal of marketing authorisation for amfepramone medicines
  • France – Intérêt du logiciel doté d’IA « PharmaClass » pour aider le pharmacien clinicien à sécuriser la prise en charge médicamenteuse
  • Europe – EMA : Complex clinical trials – Questions and answers
  • Europe – EMA publishes annual report 2021
  • UK – NICE recommends Vazkepa for patients at risk of stroke and heart attacks in England and Wales
  • USA – Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests
  • Europe – EMA adopts first list of critical medicines for COVID-19
  • USA – Cavazzoni: Pandemic-era tools, learnings are here to stay
  • India – Indian pharma to focus on quality to remain a world leader
  • Europe – EU regulators offer new guidance on complex clinical trials
  • USA – FDA withdraws cancer drug approval after finding possible higher death rates
  • UK – NICE recommends UCB’s Fintepla for Dravet syndrome
  • UK – NICE approves Merck’s Keytruda for adult patients with rare triple negative breast cancer
  • USA – FDA officials reflect on quality maturity model, quality metrics
  • UK – NICE recommends Roche’s faricimab (Vabysmo) as a treatment option for two leading forms of sight loss
  • Europe – Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
  • Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
  • UK – NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC
  • USA – Medtech groups want more time to implement FDA’s QMSR rule
  • USA – FDA issues Q&A on importation of prescription drugs from Canada
  • USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
  • Europe – EMA medical terms simplifier
  • International – Pfizer/BioNTech vaccine effective against Omicron in children five and under
  • Europe – Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements.
  • Europe – Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
  • Europe – EMA guidance supports development of new antibiotics
  • USA – Les Etats-Unis se dirigent vers la vaccination des cas contacts contre la variole du singe
  • UK – G7 health ministers unite to protect world from another pandemic
  • USA – FDA asks manufacturers to develop risk management plans to avert shortages
  • Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
  • Europe – Synchron Research Service: suspension of medicines over flawed studies
  • Europe – First therapy to treat rare genetic nervous system disorder AADC deficiency
  • Europe – First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes)
  • Europe – EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine
  • UK – NICE recommends app-based treatment for insomnia over sleeping pills
  • Canada – Update : Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format
  • USA – FDA updates guidance on evaluating out-of-specification results for drugs
  • UK – MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment
  • UK – COVID-19 vaccine study focuses on young and immunosuppressed
  • France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs
  • UK – NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer
  • USA – FDA works to advance real-world data collection in pregnancy and lactation
  • Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe
  • UK – NICE draft final guidance for Gedeon Richter UK’s new uterine fibroids treatment
  • USA – FDA guidance explains benefit-risk approach for quality assessments
  • USA – FDA launches program to speed up rare disease drug development
  • Europe – COVID-19 vaccines safety update
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
  • Europe – Rules of procedure of the Emergency Task Force (ETF)
  • Europe – EMA updates annexes on procedures for running GCP inspections
  • USA – FDA offers insight into product quality assessment principles
  • USA – FDA sheds light on conducting human radiolabeled mass balance studies
  • Europe – EMA starts review of cancer medicine Rubraca
  • International – Pherecydes Pharma : autorisation d’un 1er traitement compassionnel avec ses phages à l’international
  • France – Covid-19 : la HAS précise le cadre d’utilisation de Xevudy®
  • USA – FDA officials: ‘New normal’ may include annual COVID vaccination
  • Europe – Nouvelles règles européennes sur le devoir de vigilance
  • USA – FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease
  • France – Covid-19 : la HAS élargit l’autorisation d’accès précoce accordée à Evusheld®
  • Uk – NICE recommend exercise over painkillers for arthritis pain
  • UK – Scientists to trial world-first long-acting injection for high blood pressure
  • USA – FDA finalizes electronic postmarketing safety reporting guidance
  • USA – FDA finalizes guidance for drugs and biologics containing nanomaterials
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
  • Europe – Facilitating global access to diabetes treatments for non-EU patients
  • Europe – Euro Roundup
  • USA – Extrapolation of drug indications from study populations by FDA is ‘common’
  • UK – NICE releases revised guidelines on antidepressants
  • UK – Guidance : Pregabalin and risks in pregnancy
  • USA – Industry guidance aims to help manufacturers adhere to bar coding requirements
  • USA – Celiac disease: FDA offers guidance on drug development
  • USA – FDA offers guidance on waiver requests for pH adjusters
  • USA – FDA finalizes guidance on drug bioavailability studies
  • UK – MHRA approves the Moderna COVID-19 vaccine ‘Spikevax’ for use in 6 to 11-year olds
  • UK – NICE recommends Merck’s Tepmetko for lung cancer treatment
  • UK – Valneva COVID-19 vaccine approved by MHRA
  • USA – FDA recommends sponsors plan to include race, ethnicity in clinical trial design
  • Europe – Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trials
  • USA – FDA offers guidance on waiver requests for pH adjusters
  • France – Expérimentation du cannabis médical : évolution des critères d’inclusion dans l’indication oncologie
  • Europe – COVID-19 vaccines safety update
  • France – Coqueluche : vacciner la femme enceinte pour protéger le nouveau-né
  • Europe – EMA and the EUnetHTA 21 consortium set priorities for their collaboration
  • USA – FDA proposes rating system for pharmaceutical QMM
  • USA – FDA finalizes guidance for hepatitis B drug development
  • Canada – Special Access Program for drugs: Guidance document for industry and practitioners
  • UK – NICE overturns previous decision, recommends Merck and Pfizer’s Bavencio
  • USA – The FDA Sets Up QR Codes for Pharmaceutical Product Electronic Certificates
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
  • UK – NICE recommends Koselugo for the treatment of neurofibromatosis type 1
  • Europe – ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
  • International – ICH guideline E11A on pediatric extrapolation
  • USA – FDA delays Merck’s pneumococcal vaccine Vaxneuvance
  • USA – Alzheimer’s disease: FDA guidance had ‘strong influence’ on endpoint selection
  • UK – Guidance for people whose immune system means they are at higher risk
  • USA – USP: Supply chain experts tackle supply chain resiliency
  • Europe – MedTech Europe updates ethical code
  • UK – The IMC unites health industry professionals to combat antibiotic resistant infections
  • UK – Amgen and UCB’s Evenity recommended by NICE for severe osteoporosis
  • Europe – EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • Europe – Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
  • USA – FDA authorizes second round of mRNA boosters for older and immunocompromised people
  • Europe – EU recommendations for 2022-2023 seasonal flu vaccine composition
  • Europe – EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
  • USA – Inspections emerge as flashpoint in BsUFA II assessment meeting
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
  • Europe – New gene therapy to treat adult patients with multiple myeloma
  • Europe – EMA recommends authorisation of COVID-19 medicine Evusheld
  • USA – FDA shifts classification of some ophthalmic products to comply with Genus decision
  • Europe – Exigences de qualité pour les nanomédicaments : quel rôle pour la Pharmacopée Européenne ?
  • Europe – PROCOVA™ Handbook for the Target Trial Statistician
  • USA – USP supply chain map provides ‘early warning’ of possible drug shortages
  • UK – NICE recommends Biomarin’s Vimizim for patients with rare life-limiting metabolic disorder
  • USA – Moderna applies to FDA for authorisation for second COVID-19 booster shot for all adults
  • USA – FDA approves drug for treatment of seizures associated with rare disease in patients two years of age and older
  • Europe – Guidance on parallel EMA/EUnetHTA 21 Joint Scientific Consultation
  • Europe – Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections
  • Europe – EMA Management Board: highlights of March 2022 meeting
  • Europe – COVID-19 vaccines safety update
  • USA – FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections
  • UK – NICE to improve diagnosis for foetal alcohol spectrum disorder
  • USA – First generic of popular inhaler approved
  • Europe – Drug industry says EMA’s PRIME scheme useful but could be improved
  • Europe – Guideline on good pharmacovigilance practices (GVP)
  • USA – NIH launches clinical trial of three mRNA HIV vaccines
  • USA – FDA offers guidance on drug verification requests
  • International – Pfizer highlights need for fourth dose of COVID-19 vaccine to FDA
  • USA – Quality metrics: FDA wants feedback on pared-down program
  • Europe – COVID-19: Council agrees to extend the Regulation establishing the EU Digital COVID Certificate
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
  • Europe – Council gives green light to start negotiations on international pandemic treaty
  • International – ORGANOIDES : Néovacs investit dans NETRI et enrichit son portefeuille de participations dans des biotech françaises prometteuses
  • Europe – L’évaluation des technologies de santé au niveau européen : le Règlement tant attendu a été adopté et publié
  • USA – This Week at FDA: HHS delays SUNSET rule, FDA begins release of Comirnaty review docs, and more
  • USA – FDA calls on firms to be ‘recall ready’ in final guidance
  • USA – FDA finalizes guidance on pre-launch drug import policy
  • Europe – PRIME enables earlier availability of life-changing medicines
  • Europe – PRIME : Analysis of the first 5 years’ experience
  • UK – First RSV vaccine trial for infants offers significant results
  • UK – Previously untreatable lung cancer patients offered new therapy
  • Canada – Updated guidance: Applications for COVID-19 drug clinical trials under the Regulations
  • USA – Comments on RWD registry guidance focus on harmonization, need for details
  • Europe – Update of application forms for Certificate of Suitability applications
  • USA – FDA finalizes three guidances on cancer trials in line with Biden’s ‘Moonshot’
  • Europe – Regulation on EMA’s extended mandate becomes applicable
  • USA – USP seeks input on mRNA analytical testing guide
  • Europe – European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance
  • UK – Seagen’s Tukysa granted NICE recommendation for breast cancer patients
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
  • Europe – Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
  • Europe – New medicine for rare type of eye cancer
  • Europe – EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
  • Europe – EMA recommends approval of Spikevax for children aged 6 to 11
  • UK – NICE recommends GSK’s Zejula for patients with ovarian cancer
  • UK – London High Court rules in favour of NHS in Servier drug dispute
  • Europe – EudraVigilance – EVWEB User Manual Version 1.6
  • Europe – Inspections à distance de l’EDQM : de phase pilote à dispositif permanent du programme d’inspection
  • Europe – European medicines regulatory network adopts EU common standard for electronic product information
  • Europe – EMA : Human medicines: highlights of 2021
  • France – Médicament: la Cnil lance une consultation sur deux référentiels relatifs aux accès précoce et compassionnel
  • USA – FDA’s KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q Revision
  • USA – FDA releases 43 new and revised product-specific guidances
  • USA – Industry wants FDA to align visible particle classifications and inspections with USP
  • USA – Generic drug approvals continued to fall in 2021
  • Europe – IRIS guide to registration and RPIs
  • Europe – Ph. Eur. Commission adopts harmonised general chapter 2.2.46. Chromatographic separation techniques Back
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 February 2022
  • Europe – EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
  • Europe – PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
  • USA – FDA urges sponsors to find alternatives to nonhuman primates for toxicity studies
  • USA – FDA would rather not have to review ‘sanitation tunnels’ for COVID
  • USA – Opioid alternatives: FDA offers insights on developing non-addictive drugs for acute pain
  • USA – FDA offers insights on blood pressure studies, immunogenicity labeling
  • Europe – Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU
  • USA – FDA issues clinical pharmacology draft guidance for antibody-drug conjugates
  • Europe – EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
  • Europe – EMA offers more clarity on controlling multiple nitrosamines
  • USA – CDER unveils 30 new planned guidance documents in 2022 agenda
  • UK – Not so NICE: cancer patients miss out on innovative new treatments
  • Europe – Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg)
  • International – Omicron hospitalization risk higher among unvaccinated
  • USA – FDA rescinds approval of 29 new drug applications
  • USA – Dosing begins in mRNA HIV vaccine trial
  • UK – NHS to roll out life-saving gene therapy for rare disease affecting babies
  • USA – FDA finalizes population pharmacokinetics guidance
  • USA – FDA issues long-awaited licensing rules for drug distributors and 3PLs
  • UK – Risk-Adapted Approach to clinical trials and Risk Assessments
  • UK – NICE recommends AZ’s Forxiga for kidney disease
  • UK – Novavax COVID-19 vaccine Nuvaxovid approved by MHRA
  • USA – FDA drafts guidance on formal meetings with OTC sponsors
  • USA – PIC/S revises GMP guide to reflect new EU clinical trials regulation
  • USA – New FDA guidances aim to improve ANDA review process
  • USA – FDA finalizes guidance on premarket review of combination products
  • Europe – A stronger role for EMA
  • USA – FDA officials look outward to improve the expedited drug approval process
  • USA – Moderna begins phase 2 trial of Omicron-specific booster
  • E-santé : la HAS publie 4 référentiels de télésurveillance médicale
  • Europe – New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022
  • Europe – COMP meeting report on the review of applications for orphan designation: January 2022
  • Europe – EU publishes final arrangements for new IVDR transition in official journal
  • Europe – COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
  • Australia – Artificial Intelligence Can Save Pharmacovigilance in Australia
  • USA – Indian drugmaker gets warning letter from FDA
  • USA – New FDA guidances aim to improve ANDA review process
  • Europe – L’EMA accorde une autorisation de mise sur le marché au Paxlovid et Xenothera (Xav-19) n’a pas été autorisé par l’ANSM.
  • France – Vaccins COVID-19 et troubles menstruels : pas de lien direct selon l’ANSM
  • France – Covid-19 : comment les antiviraux luttent contre l’infection au SARS-CoV-2
  • France – CBD : le Conseil d’Etat redonne de l’air à la filière
  • Europe – Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched
  • USA – Pancreatic cancer T-cell therapy gains orphan drug tag
  • UK – New proposals for the future of UK clinical trial legislation
  • Switzerland – COVID-19 patch vaccine trial launched
  • USA – FDA could authorize COVID-19 vaccine for youths under 5 next month
  • USA – FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
  • USA – FDA outlines rules for ‘portions’ of official samples in draft Q&A guidance
  • Europe – European Parliament endorses legislation bolstering EU’s ability to tackle shortages
  • France – Covid-19 : accès précoce accordé au Paxlovid® en traitement curatif
  • Europe – International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
  • Europe – Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders
  • France – Les vaccins à ARNm contre la Covid-19 n’augmentent pas le risque d’infarctus du myocarde, d’accident vasculaire cérébral ou d’embolie pulmonaire chez les adultes de moins de 75 ans
  • France – ANSM : Periactine 4 mg (cyproheptadine) : risques liés à l’utilisation non conforme comme orexigène à des fins esthétiques
  • UK – NICE moves: increased accessibility and flexibility for health tech
  • UK – Clinical trials for medicines: authorisation assessment performance
  • Europe – COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
  • Europe – Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs
  • Europe – Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
  • USA – This Week at FDA: User fee update, Califf nomination…
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 13 January 2022
  • France – Covid-19 : deux nouvelles alternatives aux vaccins à ARNm
  • Europe – Global regulators discuss path towards regulatory alignment on response to Omicron variant
  • Europe – European Paediatric Formulary: two draft texts released for public consultation
  • USA – Industry seeks delay for reporting manufacturing volume data
  • Europe – Commission Implementing Regluation (EU) 2022/20
  • USA – Pfizer already making Omicron-specific COVID-19 vaccine
  • China – Experts suggest new method for assessing imported generic drugs in China
  • Europe – European Commission approves cystic fibrosis treatment for six to 11-year-olds
  • Europe – Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
  • USA – Manufacturers object to provisions in FDA’s microbiological quality guidance
  • Europe – EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
  • UK – The NICE recommends Rinvoq for psoriatic arthritis patients
  • Europe – Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29) in Pharmeuropa 34.1
  • USA – FDA’s drug volume reporting requirements face pushback
  • USA – FDA approved more first-in-class drugs, gave more accelerated approvals in 2021
  • France – Covid-19 : accès précoce accordé au Xevudy® en traitement curatif
  • UK – NICE recommends MSD’s Keytruda in combination with chemotherapy for routine treatment of lung cancer
  • Canada – Special Access Program for drugs: Guidance document for industry and practitioners
  • USA – Digital health tech in clinical investigations: FDA issues draft guidance
  • USA – FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies
  • Europe – Pharmeuropa 34.1 just released
  • UK – MHRA grants approval for Pfizer’s oral COVID-19 antiviral pill
  • Europe – Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines
  • UK – The past, the present, and the future of clinical trials transparency in the UK
  • France – Arrêté du 25 octobre 2021 fixant le règlement intérieur type des CPP
  • USA – Pfizer COVID-19 pill garners FDA authorization
  • USA – NIH celebrates FDA approval of long-acting injectable drug for HIV prevention
  • Europe – BSP study outcomes published in Pharmeuropa Bio & Scientific Notes
  • Europe – Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
  • Europe – All you ever wanted to know about Ph. Eur. procedure 4 but never dared ask!
  • Europe – Liposomal amphotericin B product-specific bioequivalence guidance
  • Europe – Ursodeoxycholic acid product-specific bioequivalence guidance
  • Europe – Draft olaparib 100 mg & 150 mg film-coated tablets product-specific bioequivalence guidance
  • Europe – EMA recommends Nuvaxovid for authorisation in the EU
  • Europe – EMA and ECDC recommendations on heterologous vaccination courses against COVID-19: ‘mix-and-match’ approach can be used for both initial courses and boosters
  • Europe – EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
  • UK – NICE recommends monotherapy for adjuvant treatment of stage 3 melanoma
  • Europe – New treatment for sickle cell disease
  • USA – FDA addresses establishment of inspection programs for injectables
  • Europe – Heterologous primary and booster COVID-19 vaccination
  • Europe – Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg)
  • Europe – EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
  • France – Un référentiel unique d’interopérabilité du médicament disponible au quatrième trimestre 2022 (ANS)
  • Europe – COVID-19: EMA recommends authorisation of antibody medicine Xevudy
  • Europe – EMA recommends approval for use of Kineret in adults with COVID-19
  • UK – NICE recommend venetoclax and azacytidine for patients with aggressive blood cancer
  • UK – Study finds Omicron multiplies 70 times faster than Delta, UK COVID-19 cases exceed 75,000
  • France – Covid-19 : deux nouveaux traitements évalués par la HAS
  • USA – Unannounced FDA inspections in India, China to begin soon
  • Europe – EMA launches the Regulatory Science Research Needs initiative
  • UK – Needle free COVID-19 vaccine trialled in UK
  • Europe – COVID-19 Vaccine Janssen: EMA recommendation on booster dose
  • Europe – European Pharmacopoeia Supplement 10.8 now available
  • USA – FDA releases draft guidances on developing rhinosinusitis drugs, colonoscopy bowel preps
  • USA – Viagra associated with reduced risk of Alzheimer’s disease
  • Europe – EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
  • USA – FDA issues final guidance on pediatric anti-infective development
  • UK – Five-drug combination for ultra-high-risk bone marrow cancer identified
  • Switzerrland – Covid-19 : la Suisse travaille sur quatre médicaments
  • Europe – EMA : COVID-19 vaccine safety update Janssen
  • USA – Pharma, device groups oppose FDA’s planned drug to device transition
  • USA – FDA approves first pre-exposure prophylactic against COVID-19
  • Europe – EMA : COVID-19 vaccine safety update Spikevax
  • Europe – EMA : COVID-19 vaccine safety update Comirnaty
  • Europe – EMA : COVID-19 vaccine safety update Vaxzevria
  • USA – FDA guidance targets CMC changes in biologic products
  • Europe – International regulators stress continued need for COVID-19 therapeutics
  • UK – NICE publish final guidance recommending Aspaveli in adults with ultra-rare blood disorder
  • USA – FDA issues draft guidance on study designs using real-world data
  • UK – Omicron rise prompts tougher measures in England
  • USA – Consensus lacking on ‘value’ for new anticancer drugs
  • Europe – Formulaire pédiatrique européen : deux projets de textes publiés pour enquête publique
  • USA – FDA rolls out more guidance on ‘N of 1’ gene therapies
  • Europe – EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns
  • Europe – EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
  • Europe – EMA recommends approval for use of RoActemra in adults with severe COVID-19
  • USA – FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021
  • USA – FDA announces FY 2022 GDUFA science and research priorities
  • UK – MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and death by 79%
  • Europe – EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
  • Europe – New reports address generics pricing, innovation in the EU
  • Europe – EU official says ICH Q6B is outdated and needs revision
  • USA – US regulators set to approve oral antiviral against COVID-19
  • International – COVID-19 vaccines against Omicron may be fast-tracked
  • France – L’accès précoce confronté aux difficultés du recueil de données en vie réelle
  • USA – FDA offers draft guidance for registries as RWD
  • UK – COVID-19 vaccines safe for pregnant women
  • USA – First trial of a vaccine against Alzheimer’s launches
  • Europe – Évolution des délais de traitement des demandes de CEP par l’EDQM
  • Europe – Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
  • Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
  • Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
  • Europe – EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
  • UK – NICE approves hormone drug which could prevent 1,200 miscarriages each year
  • Europe – A vision for use of real-world evidence in EU medicines regulation
  • USA – FDA suggests alternative approaches for nitrosamine risk assessments
  • USA – FDA shares research to improve dose selection in pediatric drug development
  • Europe – EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19
  • UK – NICE recommends risdiplam for spinal muscular atrophy
  • USA – GAO: Pathway for antimicrobial drug development leads to few approvals
  • Europe – PRAC recommendations on signals 25-28 October 2021 PRAC meeting
  • UK – UK’s NICE recommends Roche’s Evrysdi
  • Europe – EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
  • France – Didier Raoult accusé de fraude par ses équipes sur l’hydroxychloroquine
  • Europe – Euro Roundup: EFPIA calls for EU to drive reform of WTO, shares feedback on emergency authority
  • France – Covid-19 : la HAS préconise une dose de rappel pour les personnes de 40 ans et plus
  • USA – FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism
  • Europe – EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
  • Europe – EMA starts review of Paxlovid for treating patients with COVID-19
  • UK – NICE recommends Inrebic for rare blood cancer
  • Europe – EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
  • UK – NICE approves first long-acting jab for HIV to replace daily pills
  • Switzerland – COVID-19 vaccine for children aged 6 to 11: Moderna submits application for indication extension
  • USA – FDA urged to endorse EPCIS to spur manufacturers’ uptake of DSCSA
  • Europe – EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
  • Europe – Pharmeuropa 33.4 just released
  • UK – UK disposed of 600,000 AZ vaccine doses after they passed expiry date
  • Europe – EDQM Laboratory’s ISO 17025:2017 accreditation renewed
  • Europe – Forxiga (dapagliflozin) 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus
  • UK – NICE recommends cenobamate for treatment of adult epilepsy patients in UK
  • USA – Study: RWD not ready for postapproval prime time
  • USA – FDA: Biosimilar program a success, but challenges remain
  • USA – COVID-19 therapeutics tracker
  • Europe – First-in-class medicine recommended for treatment of rare blood vessel inflammation
  • UK – NICE ‘no’ for BioMarin’s Vimizin
  • UK – New drug combination highly effective in children with leukaemia
  • UK – New COVID-19 vaccines could target replication proteins
  • Europe – Euro Roundup: EU extends scope of guideline on clinical trials with genetically modified human cells
  • Europe – COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
  • Europe – ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticals
  • Europe – ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products – Step 2b
  • UK – Updated guidelines for managing long-term effects of COVID-19 published
  • UK – University of Oxford begins human trials of Ebola vaccine
  • Europe – EMA : Covid-19 vaccine safety update – Spikevax
  • Europe – EMA : Covid-19 vaccine safety update – Vaxzevria
  • Europe – EMA : Covid-19 vaccine safety update – Comirnaty
  • Europe – EMA : Covid-19 vaccine safety update – Janssen
  • USA – Industry calls for technical, scope changes in ICH S12 guideline
  • Europe – EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
  • USA – White paper bolsters ctDNA as potential ‘early endpoint’ in cancer approvals
  • Europe – COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
  • USA – FDA taking incremental approach to launching KASA reviews
  • Europe – Draft qualification opinion of Islet Autoantibodies (AAs) as Enrichment Biomarkers for Type 1 Diabetes (T1D) Prevention Clinical Trials
  • France – HAS : Cancer du sein triple négatif : la HAS autorise le Keytruda en accès précoce
  • UK – UK’s MHRA approves first oral antiviral against COVID-19
  • UK – NICE issues draft recommendation for new kidney disease treatment
  • UK – NICE recommends Namuscla for NHS to treat genetic disorder
  • Switzerland – AstraZeneca withdraws authorisation application for COVID-19 vaccine in Switzerland
  • USA – Pandemic has challenged industry’s implementation of DSCSA
  • USA – FDA reiterates support for semi-distributed tracing model under DSCSA
  • USA – GDUFA III commitment letter details coming changes to FDA’s generic review program
  • Europe – EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
  • USA – FDA issued vaccine EUAs without facility inspections: GAO
  • USA – Nitrosamine detection tests should be ‘fit for purpose,’ says FDA
  • Europe – EMA encourages companies to submit type I variations for 2021 in November 2021
  • Europe – Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia
  • Europe – EMA nod for excessive daytime sleepiness med Ozawade
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
  • UK – Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines
  • USA – FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases
  • Europe – Compilation of Union procedures on inspections and exchange of information
  • Europe – European Health Union: Commission establishes portfolio of 10 most promising treatments for COVID-19
  • UK – NICE does not recommend tucatinib for advanced breast cancer
  • Europe – Spikevax: EMA recommendation on booster
  • Europe – COVID-19: EMA starts rolling review of molnupiravir
  • USA – FDA drafts data standards guidance for RWD
  • USA – Moderna COVID-19 vaccine generates long-lasting immune memory
  • UK – NICE recommends gene silencing therapy for porphyria patients on NHS
  • USA – FDA okays Moderna, J&J, ‘mix and match’ boosters
  • Europe – EMA shares lessons learned from biosimilars pilot
  • USA – The FDA vaccine advisory board recommends booster shots of both the J&J and Moderna vaccines
  • Europe – Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders
  • Europe – EC updates Clinical Trial Regulation Q&As ahead of January go-live
  • France – Les pharmaciens officinaux autorisés à reconstituer les vaccins à ARN messager, et à les distribuer
  • France – La vaccination est efficace à plus de 90% pour réduire les formes graves de Covid-19 chez les personnes de plus de 50 ans en France
  • France – Sérialisation: arbitrage ministériel en cours sur un soutien financier aux officinaux
  • USA – FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
  • Europe – EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
  • UK – NICE approves Ofev for PF-ILD
  • France – Covid-19 : utiliser le vaccin de Pfizer pour le rappel de vaccination
  • USA – FDA adcomm unanimous on J&J boosters for all
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021
  • UK – NICE clears Opdivo for resected oesophageal or gastro-oesophageal junction cancer
  • Europe – First-in-class medicine to treat aggressive form of breast cancer
  • Europe – European Pharmacopoeia device version to be discontinued
  • USA – Unanimous thumbs up from FDA committee for Moderna booster
  • Europe – Revised osmolality chapter for public comment in Pharmeuropa
  • Europe – COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)
  • Europe – Vaxzevria : risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding
  • Europe – EMA : Final Programming Document 2021-2023
  • Europe – EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
  • Europe – A global approach to regulatory flexibility to increase manufacturing capacity during COVID-19
  • USA – New USP chapter details lifecycle approach to analytical testing
  • USA – FDA official breaks down novel excipient pilot program
  • USA – FDA’s accelerated approval program: Is change on the way?
  • Europe – Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines
  • USA – FDA recognizes Memorial Sloan Kettering tumor variant database
  • Europe – Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa
  • Europe – EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
  • UK – NHS encourages pregnant women to get COVID-19 vaccine
  • UK – NICE backs Rinvoq for moderate active RA
  • Europe – European Union Clinical Trials Information System CTIS: Go-live Planning
  • UK – Fungus-derived cancer killing drug by Oxford University shows promise
  • UK – NICE recommends Novartis’ Adakveo for sickle cell disease
  • Europe – EMA : COVID-19 vaccine safety update : COMIRNATY
  • Europe – EMA : COVID-19 vaccine safety update : VAXZEVRIA
  • Europe – EMA : COVID-19 vaccine safety update : Janssen
  • Europe – EMA : COVID-19 vaccine safety update : Spikevax
  • UK – First subject given COVID-19 vaccine candidate in UK-based Scancell’s COVIDITY trial
  • USA – FDA seeks to update compounding guidance for hospital pharmacies
  • Europe – New guide to clinical trial lay summaries available for EU sponsors
  • Europe – Pharmeuropa 33.4 just released
  • France – Oncologie: Pierre Fabre lance une plateforme pour accompagner les pharmaciens d’officine
  • USA – US FDA says efficacy data from 2 Indian CROs is invalid
  • USA – FDA issues guidance on NSD microbial contamination control
  • USA – FDA guidance focuses on RWD from medical claims, EHR
  • UK – MSD: Antiviral COVID-19 pill can halve the risk of hospitalisation and death
  • Europe – Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
  • Europe – EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
  • China – Clinical evaluation authority, plus guidelines for animal testing studies
  • USA – FDA drafts safety reporting guidance for drug and device investigators
  • USA – FDA draft guidance outlines criteria for conducting benefit/risk assessments
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021
  • USA – For gene therapies, FDA drafts trial guidance, finalizes « sameness » for orphan exclusivity
  • Europe – EU extends GMP, GDP certificates through 2022 as pandemic effects linger
  • Europe – European Health Union: Towards a reform of EU’s pharmaceutical legislation
  • UK – NICE recommends life-extending urothelial cancer treatment
  • USA – FDA addresses microbial contamination in non-sterile drugs
  • USA – FDA issues draft guidance on RWD sourced from EHRs, claims data
  • Europe – EMA implements new measures to minimise animal testing during medicines development
  • Europe – Risque de présence d’impuretés azoturées mutagènes dans le losartan (substance active)
  • USA – Drugs for non-TB pulmonary disease see new FDA guidance
  • USA – Pfizer to soon submit data on Covid vaccine for kids aged 5-11
  • Europe – EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
  • France – Covid-19 : la HAS précise les populations éligibles à une dose de rappel de vaccin
  • USA – FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions
  • USA – COVID-19 Pfizer/BioNTech booster approved by FDA and CDC
  • Europe – New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders
  • Europe – Vaccines Europe makes the case for vaccine-specific HTA
  • USA – FDA guidance covers frequently asked CMC questions for generic drugs
  • Europe – Use of Vaxzevria to prevent COVID-19 – Article-5(3) procedure: Final assessment report
  • UK – NHS patients gain access to COVID-19 treatment Ronapreve
  • USA – FDA finalizes more Q&As on biosimilar development
  • USA – La FDA se réorganise et crée un  »bureau de la transformation numérique »
  • UK – BioCryst’s HAE med Orladeyo wins NICE nod
  • Europe – EU “still interested” in Valneva COVID vaccine despite UK snub
  • USA – In advance of adcomm, Pfizer makes its case for Comirnaty booster
  • UK – NICE backs Opdivo for head and neck cancer
  • UK – UK announces COVID boosters for a “bumpy winter” ahead
  • USA – Medicare could negotiate drug prices under Biden plan
  • Europe – EMA : Guidance documents
  • International – Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting
  • USA – FDA launches excipient pilot program
  • USA – FDA reaches milestone in generics approvals
  • USA – Industry calls for withdrawal of FDA electronic tracing guidance
  • Europe – HMA-EMA plans real-world metadata framework for regulatory decision-making
  • UK – NICE OKs Xeljanz for individuals with juvenile idiopathic arthritis
  • USA – FDA updates guidance on generic drug development during COVID
  • Europe – Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer
  • UK – MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
  • UK – Novavax begins COVID-19, flu combination vaccine trial
  • Europe – COVID-19 vaccine safety update : Vaxzevria
  • Europe – COVID-19 vaccine safety update : Spikevax
  • Europe – COVID-19 vaccine safety update : Comirnaty
  • Europe – COVID-19 vaccine safety update : Janssen
  • UK – Future of MHRA uncertain amid Brexit-fuelled shake up
  • UK – NICE changes its mind on Janssen’s Erleada
  • Europe – Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities
  • USA – FDA revises MAPPs on data standards program, scientific interest groups
  • France – Cancer du sein triple négatif : la HAS autorise le Trodelvy en accès précoce
  • USA – FDA issues updated clinical trial guidance amid pandemic
  • France – Synapse Medicine décroche la certification « logiciel d’aide à la prescription »
  • France – Sérialisation: les ARS somment les pharmaciens d’appliquer  »sans délai » la réglementation
  • France – Études en vie réelle pour l’évaluation des médicaments et dispositifs médicaux
  • Europe – Revised guidance for electronic submissions for CEP applications
  • Europe – Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6
  • UK – UK’s NICE recommends anti-cholesterol Leqvio for high-risk patients
  • USA – Moderna submits its COVID-19 vaccine booster to the FDA
  • UK – NICE recommends Novartis’ Cosentyx for children with severe psoriasis
  • Europe – ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
  • Asia – Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues
  • France – Lutte contre l’antibiorésistance : choix et durée de prescription des antibiotiques dans les infections bactériennes courantes
  • Europe – EMA goes all in on big data
  • International – How mRNA therapeutics are entering the monoclonal antibody field
  • USA – FDA warns public against off-label use of Pfizer vaccine
  • Europe – EMA fast-tracks Marinus Pharma’s rare epilepsy treatment
  • UK – NICE ‘no’ for Janssen’s Darzalex combo
  • USA – Cancer immunotherapy alternative dosing regimens: New FDA draft guidance
  • USA – FDA issues 39 new and revised product-specific guidances
  • USA – FDA fleshes out models for safe continuous manufacture of therapeutic proteins
  • USA – FDA Approves First COVID-19 Vaccine
  • Europe – COVID-19 vaccine safety update COMIRNATY
  • Europe – COVID-19 vaccine safety update SPIKEVAX Moderna Biotech Spain
  • Europe – COVID-19 vaccine safety update COVID-19 VACCINE JANSSEN
  • UK – NICE recommends Novartis’ Rydapt for AdvSM treatment
  • UK – First monoclonal antibody treatment for COVID-19 approved for use in the UK
  • UK – NICE’s health technology assessment methods and processes to be evaluated
  • UK – NICE recommends Eli Lilly’s breast cancer drug Verzenios
  • Europe – COVID-19 vaccine safety update VAXZEVRIA (AstraZeneca AB)
  • Europe – Artificial intelligence in medicine regulation
  • International – AZ to seek approval for « long-acting » COVID-19 antibodies
  • UK – UK approves Regeneron’s COVID-19 antibody cocktail
  • UK – New BRCA-targeting drug could treat advanced prostate cancer
  • UK – Valneva starts MHRA regulatory process for COVID-19 vaccine
  • USA – FDA refreshes bioequivalence guidance for generic drugs
  • Canada – First oral antiviral drug for COVID-19 reviewed by Health Canada
  • Europe – EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
  • International – Moderna’s COVID-19 vaccine maintains antibodies to six months, study shows
  • India – Pharmaceutical supply disruptions predicted in India
  • USA – Near-infrared guidance finalized for small molecule testing, with biologics to come
  • USA – FDA finalizes guidance on metastasis-free survival as an endpoint for prostate cancer trials
  • UK – Moderna COVID-19 vaccine approved by MHRA in 12-17 year olds
  • UK – Combined paracetamol and ibuprofen medicine approved for general sale
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
  • Europe – Clinical Trials Information System (CTIS) highlights – August 2021
  • Europe – ECDC and EMA update on COVID-19
  • UK – 16- and 17-year-olds should receive first COVID-19 vaccine, advises JCVI
  • USA – Positive Phase III results for Valneva’s chikungunya vaccine
  • Europe – Interoperability of track and trace systems: key to public health protection
  • USA – FDA finalizes long-awaited intended use rule
  • Europe – EFPIA, others question EC’s proposed orphan and pediatric drug development updates
  • USA – FDA expands use of COVID-19 antibody cocktail
  • UK – Gov’t launches study on COVID-19 vaccine dose interval for pregnant women
  • Europe – New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products
  • UK – UCB’s bimekizumab issued NICE recommendation for severe plaque psoriasis
  • Europe – Six-month countdown to go-live for the Clinical Trials Information System (CTIS)
  • Europe – Increased manufacturing capacity and supply for Spikevax
  • USA – Updated: FDA grants industry 30-day extension to comment on track and trace guidance
  • Europe – Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.
  • UK – NICE publishes ‘rapid’ guideline on rare blood clots associated with COVID-19 jab
  • Europe – EMA updates reflection paper on GMP responsibilities of marketing authorization holders
  • USA – FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
  • USA – FDA sets deadline for study data technical rejection criteria
  • USA – FDA’s revised MAPP outlines procedures for generic drug labeling changes
  • International – J&J and Pfizer quietly resolve Remicade biosimilar lawsuit
  • Europe – Statistical methodology for the comparative assessment of quality attributes in drug development
  • UK – NICE publishes new draft guideline covering rehabilitation after traumatic injury
  • USA – FDA seeks comments on regulation of kratom, 6 other drugs
  • USA – FDA declines to extend nitrosamine risk assessment deadline
  • Europe – Guideline on quality documentation for medicinal products when used with a medical device
  • Europe – EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
  • Australia – TGA international engagement strategy 2021-2025
  • Europe – COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021
  • Europe – CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer
  • UK – NICE, PHE publish new antimicrobial prescribing guideline on C. difficile infection
  • Europe – Notifying a change of marketing status (Update)
  • Europe – Euro Roundup
  • Europe – COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
  • USA – FDA unveils final guidance on field alert reports
  • UK – NICE recommends Incyte’s Pemazyre for rare bile duct cancer
  • France – Médicament: la collecte de données de vie réelle renforcée par la réforme de l’accès précoce
  • France – Cercles de qualité médecins-pharmaciens : une initiative bienvenue
  • UK – Ledaga recommended by NICE for rare type of lymphoma
  • UK – NICE’s decision not to approve Zytiga ‘frustrating’, says ICR
  • Europe – EMA starts rolling review of COVID-19 vaccine Vidprevtyn
  • Europe – COVID-19 treatments: under evaluation
  • Europe – EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
  • USA – Industry consortium releases blueprint for DSCSA tracking systems
  • France – Décision n° 2021.0187/DC/MNS du 8 juillet 2021 du collège de la Haute Autorité de santé portant actualisation de la procédure de référencement des systèmes d’aide à la décision indexée par médicament (SAM) à intégrer dans les logiciels d’aide à la prescription et dans les logiciels d’aide à la dispensation
  • Europe – European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting (April 2021)
  • France – Vaccination contre la Covid-19 : pas de dose de rappel pour le moment en dehors des plus vulnérables et des plus âgés
  • UK – Combined review to facilitate speedier set up for clinical research trials
  • International – International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines
  • Europe – CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3
  • Europe – Covid-19 vaccine safety update : Spikevax
  • Europe – Covid-19 vaccine safety update : Janssen
  • Europe – Covid-19 vaccine safety update : Vaxzevria
  • Europe – Covid-19 vaccine safety update : Comirnaty
  • France – Un décret encadre l’échange de données de santé issues du DMP entre la France et des Etats de l’UE
  • USA – US FDA guidelines for remote inspections of drug facilities: Implications for life sciences companies
  • Europe – EMA and ECDC update on COVID-19
  • USA – FDA sees different tactics were successful in established conditions pilot
  • Asia – Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies
  • Europe – EMA guidelines highlight changes to IMPs triggering notification to regulators
  • Europe – Implementation of the European Pharmacopoeia Supplement 10.6 – Notification for CEP holders
  • USA – CBER Q&A addresses stem cell enforcement questions
  • Europe – New monograph on a single-source anti-TNF-alpha monoclonal antibody released for public consultation in Pharmeuropa
  • France – Données de vie réelle: un potentiel reconnu pour l’évaluation des produits de santé, des biais en embuscade (Afcros)
  • China – China announces new guidelines for oncology drugmakers
  • USA – FDA approves 29 new drugs so far this year
  • USA – Pfizer, BioNTech eye US approval for COVID-19 booster dose
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021
  • Europe – EMA finds no evidence linking viral vector in Zynteglo to blood cancer
  • Europe – Consideration on core requirements for PSURs of COVID-19 vaccines
  • Europe – Revised general chapter 5.21 Chemometric methods applied to analytical data published for public comment in Pharmeuropa
  • Europe – Euro Roundup
  • USA – FDA calls for new warning labels on hydroxyethyl starch products
  • Europe – EMA updates Q&A on nitrosamine assessment and testing
  • International – Moderna launches phase 1/2 study of mRNA-based flu vaccine
  • UK – REACT-1 study of coronavirus transmission: June 2021 interim results
  • USA – FDA finalizes guidance on studying CNS metastases in cancer trials
  • Europe – Highlights of 2020 – EDQM annual report now available
  • UK – Freedom of Information responses from the MHRA – week commencing 3 May 2021
  • Europe – EDQM fertility preservation guide now available
  • Europe – Pharmeuropa 33.3 just released
  • France – HAS – Publication du guide intitulé « Autorisation d’accès précoce aux médicaments : doctrine d’évaluation de la HAS »
  • France – Décision n° 2021.0157/DC/SEVOQSS du 10 juin 2021 du collège de la Haute Autorité de santé portant adoption du document Flash sécurité patient « Médicaments à risque « Sous-estimer le risque c’est risqué »
  • USA – Guidance : Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
  • USA – FDA report examines use of patient experience data in decision-making
  • Europe – EDQM “RTEMIS” pilot project: real-time remote GMP inspections of API manufacturers
  • USA – FDA issues draft guidance for transdermal adhesion systems
  • Europe – Outcome of the 170th session of the European Pharmacopoeia Commission, June 2021
  • USA – FDA issues final guidance on providing regulatory submissions in alternate electronic formats
  • Europe – Cambridge University scientists identify 160 new drugs with COVID-19 repurposing potential
  • USA – FDA studies: No post-ingestion NDMA from ranitidine
  • Europe – Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
  • Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
  • Europe – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
  • Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
  • Europe – Scientific recommendations on classification of advanced therapy medicinal products
  • Europe – Conseil et Parlement Européen : projet de renforcement du rôle de l’EMA relatif aux médicaments et DM
  • Europe – EC issues first COVID therapeutics portfolio
  • USA – Single-shot COVID-19 vaccine produces immune response against variants
  • Europe – Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes
  • USA – FDA releases new draft guidance on sponsor role for safety reporting requirements
  • Europe – L’essai des pyrogènes sur lapin bientôt supprimé de la Pharmacopée Européenne
  • Europe – Update : Consideration on core requirements for RMPs of COVID19 vaccines
  • Europe – Update of EU recommendations for 2021–2022 seasonal flu vaccine composition
  • Europe – Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus
  • Europe – EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021
  • Europe – First cell-based gene therapy to treat adult patients with multiple myeloma
  • Europe – New treatment for people with dwarfism
  • USA – FDA calls for inclusion of patients with incurable cancers in oncology trials
  • Europe – Le GDP déploie des efforts afin d’impliquer d’autres pharmacopées de l’ICH dans le maintien à jour des annexes du guideline ICH Q4B
  • USA – NIH begins study of COVID-19 vaccination during pregnancy and postpartum
  • Europe – Clinical Trials Information System (CTIS) highlights – June 2021
  • Europe – Health Technology Assessment: Informal deal between Council and European Parliament
  • USA – Final FDA guidance targets biological product changes
  • France – Méningocoques B : la HAS recommande la vaccination des nourrissons
  • USA – Guidance : Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
  • Europe – Questions and answers on labelling flexibilities for COVID19 vaccines
  • Europe – COVID-19 vaccine safety update : VAXZEVRIA
  • Europe – COVID-19 vaccine safety update : COMIRNATY
  • Europe – COVID-19 vaccine safety update : JANSSEN
  • Europe – COVID-19 vaccine safety update : MODERNA
  • Europe – Disappointing results from CureVac’s COVID-19 vaccine as phase 2/3 study shows only 47% efficacy
  • UK – Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses
  • UK – Regeneron’s COVID-19 drug boosts survival in hospitalised patients lacking antibodies
  • USA – Best practices and education for probiotics amid regulatory uncertainty
  • USA – FDA approves weight management drug for patients aged 12 and older
  • Europe – Consideration on core requirements for RMPs of COVID-19 vaccines
  • Europe – La Commission économique eurasienne et l’EDQM conviennent d’étendre et de renforcer la collaboration internationale en matière de circulation des médicaments
  • USA – FDA launches global Generic Drug Cluster
  • Europe – Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID
  • Europe – EMA : Annual report 2020 published
  • Europe – COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021
  • Europe – Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
  • Europe – COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
  • Canada – Release of Draft (Step 2) ICH Guidance: S1B(R1): Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals
  • Canada – Release of ICH Q3C(R8): Impurities: Guideline for Residual Solvents
  • USA – US to donate 500 million Pfizer/BioNTech COVID-19 vaccine doses through COVAX
  • USA – Allegations of fraud levied at COVID-19 vaccine maker
  • USA – FDA releases draft guidance on assessment of PROs for cancer trials
  • India – India lowers bar for approval of COVID-19 vaccines already authorized overseas
  • Europe – EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
  • USA – Maladie d’Alzheimer : trois questions sur le nouveau médicament autorisé aux Etats-Unis
  • USA – FDA testing bioequivalence data assessment tool
  • USA – FDA approves weekly injectable for obesity, overweight
  • Europe – Draft EU Common Standard for electronic product information for human medicines (ePI)
  • USA – Pharmaceutical officials propose new USP harmonized chapter on visual inspections
  • USA – Smallpox antiviral approved under FDA’s Animal Rule
  • USA – FDA Grants Accelerated Approval for Alzheimer’s Drug
  • UK – ‘Indian’ variant of coronavirus now dominant strain in the UK
  • UK – NICE draft guidance does not recommend Evrysdi for SMA
  • USA – Moderna begins process for full FDA approval for COVID-19 vaccine
  • Europe – EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
  • USA – FDA details plans for DSCSA implementation in four guidances
  • USA – FDA issues new MAPP on reviewing color additives
  • Europe – Advancing international collaboration on COVID-19 real-world evidence and observational studies
  • Europe – Euro Roundup: Switzerland moves to mitigate split from EU on device regulation
  • Europe – EU regulators develop recommendations to forecast demand of medicines
  • USA – FDA provides draft guidance for enteral tube-administered drugs
  • Catégorie : International
    • International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation
    • International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals – Step 5
    • International – ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products – Step 2b – Scientific guideline
    • International – Generic industry group wants clarity on ICH bioequivalence guideline
    • International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
    • International – ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk
    • Europe – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
    • International – ICH adopts S12 guideline for gene therapies
    • International – EMA-FDA parallel scientific advice program has ‘limited’ uptake
    • International – Bébé-Crispr : la modification du génome d’embryon bute sur des obstacles techniques
    • International – ICH to adopt final guideline on drug interaction studies early next year
    • International – Industry groups call for changes in ICH M11 guideline on harmonized protocols
    • International – ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
    • International – ICH adopts Q9 guidelines on quality risk management
    • USA – Pharma groups say ICH guideline on viral safety evaluation needs to incorporate continuous manufacturing
    • International – WHO warns on contaminated cough syrups linked to child deaths
    • International – ICH guideline M10 on bioanalytical method validation and study sample analysis – Questions and Answers
    • International – ICH releases draft guideline proposing harmonized bioequivalence testing
    • International – Covid-19 nasal vaccine is here: Price, benefits, all you need to know
    • International – Efficacité et tolérance des vaccins contre la COVID‐19
    • International – ICH adopts Q13 guideline on continuous manufacturing
    • International – Un médicament fait espérer l’éradication de la maladie du sommeil
    • International – ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
    • International – Biosimilars, are they comparable to their reference counterparts?
    • International – WHO launches R&D efforts to identify pathogens that could cause future pandemics
    • International – Modular plug-and-produce facilities for cell therapies
    • International – ICH M11 guideline, clinical study protocol template and technical specifications
    • International – ICH : Clinical Electronic Structured Harmonised Protocol (CESHARP) M11
    • International – ICH releases M11 guideline proposing harmonized template for trial protocols
    • International – ICH advances guidelines on selective reporting of safety data, viral safety
    • International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
    • International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin (Step 2b)
    • International – ICH M12: Pharma industry wants clarity on rifampin dosing, more information on biomarkers
    • International – ICH Q14: Pharma groups want clarity on benefits of enhanced approach
    • International – WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out
    • International – Pfizer doses first patients with mRNA-based influenza vaccine
    • International – Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2)
    • International – ICH signs off on carcinogenicity testing addendum
    • International – Novartis confirms death of 2 children after gene therapy
    • International – ICH M10 on bioanalytical method validation
    • International – Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines
    • International – Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine
    • International – Moderna announces trial results for new COVID-19 booster vaccine candidate
    • International – ICH details milestones reached on guidelines after Athens meeting
    • International – FDA, EMA officials discuss impediments to cell and gene therapies
    • International – International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines
    • International – WHO recommends Veklury for high-risk patients
    • International – ICH plans model-informed drug development guideline in 3-4 years
    • International – Mechanical, material stresses affect drug quality
    • International – ICH releases draft guidelines on analytical method development
    • International – Excipient group releases guide on reporting microplastic use in pharmaceuticals
    • International – ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
    • International – ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs – questions and answers
    • International – Drop in data integrity violations linked to fewer inspections
    • International – Pfizer begins phase 2/3 study of oral COVID-19 treatment in paediatric patients
    • International – How will war in Ukraine affect global biopharma industry?
    • International – Report predicts a biosimilar « turning point » in 2022
    • International – Covid-19 : l’OMS recommande le traitement de Merck aux patients à risque
    • Interrnational – WHO issues prequalification for Roche’s Actemra/RoActemra for severe or critical COVID-19
    • International – ICH guide provides clarity on estimands, sensitivity analyses
    • International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
    • International – Pfizer and BioNTech start clinical trial for Omicron-based COVID-19 vaccine
    • International – Access Consortium Work-Sharing Initiative: An Industry Perspective
    • International – Covid-19: Un vaccin annuel préférable à des rappels fréquents selon Pfizer
    • International – WHO recommends baricitinib, sotrovimab to combat COVID-19
    • International – WHO charts path to convergence on cell and gene therapies
    • International – ICH releases revised Q9 guideline to improve risk assessments
    • International – Pharmaceutical groups want more clarity on continuous manufacturing guideline
    • International – ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
    • International – ICMRA: Remote inspections can complement, but not replace, onsite inspections
    • International – Pfizer/BioNTech promote booster against Omicron
    • International – ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
    • International – Booster plans expanded to combat Omicron
    • International – ICH recaps progress made over past year, charts new topics
    • Israel – Israel approves COVID-19 vaccines for children aged 5-11
    • International – Phagothérapie : un modèle animal pour étudier son potentiel antibactérien
    • International – COVID-19 vaccine tracker
    • International- Release of Draft (Step 2) ICH Guideline: Q13: Continuous Manufacturing of Drug Substances and Drug Products
    • International – ICH : 30th Anniversary Publication
    • International – ICH guideline E8 (R1) on general considerations for clinical studies
    • International – New WHO group could be ‘the last to find virus origins’
    • International – ICMRA: Industry’s commitment to quality can facilitate regulatory flexibility
    • International – Results of AstraZeneca’s TACKLE phase 3 trial show antibody combination reduces risk of severe COVID-19 or death
    • International – WHO has recommended GSK’s malaria vaccine for children
    • International – Covid-19 : que sait-on du nouveau médicament Molnupiravir ?
    • International – ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
    • International – ICH announces sign-off on good clinical practices guideline
    • International – WHO updates essential medicines lists
    • International – Janssen’s RSV vaccine provides high protection against respiratory infections
    • International – WHO seeks input on medicines to prioritize for BCS-based biowaivers
    • International – A new oral antiviral drug for COVID-19 is being tested in humans – can it make a difference?
    • International – UK vaccine swap with South Korea in joint effort against COVID-19
    • International – Positive topline results for Pfizer/BioNTech jab in five to 11-year-olds
    • International – ICH survey shows strong level of guideline implementation
    • International – FDA, EMA launch complex generic, hybrid product advice pilot
    • International – EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products
    • International – Convergence: Regulatory considerations in advancing gene and cellular therapies
    • International – Vaccin contre le Covid-19 : bientôt un spray nasal pour stopper le virus ?
    • International – Drugmakers should question suppliers’ nitrosamine tests
    • International – The most-used drugs for treating COVID-19
    • International – Interventions dans la prévention des troubles persistants de l’odorat (dysfonctionnement olfactif) suite à une infection par la COVID-19
    • Denmark – Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination
    • International – L’ICMRA cible les défis posés par l’IA dans le développement du médicament
    • International – BioNTech says booster doses may be more effective than a modified COVID-19 vaccine
    • International – WHO to test three more potential COVID-19 treatments
    • International – Researchers: France could teach the US lessons in biosimilar pricing
    • International – ICMRA releases framework for aligning global track and trace systems
    • International – WHO revises guidance on GMPs for investigational products, R&D facilities
    • International – Early data shows CanSinoBIO’s inhaled COVID-19 vaccine triggers immune response
    • International – Study shows AZ’s COVID-19 jab did not increase the rate of rare blood clots after second dose
    • International – ICH releases widely anticipated guidance on continuous manufacturing
    • International – Google’s DeepMind opens ‘breakthrough’ protein database to the world
    • International – BioNTech to use mRNA technology to develop a ‘highly effective’ malaria vaccine
    • International – Mixing AZ and Pfizer COVID-19 vaccines increases antibody levels
    • International – Global regulators promote platform trials to assess new COVID vaccines
    • International – PIC/S adopts guidance on PQS risk-based change management, COVID-19 risk assessments
    • International – AZ, J&J to research modifications to COVID-19 vaccines over rare blood clot issues
    • International – Upcoming ICH guidelines should ease post-approval changes for analytical methods
    • International – PIC/S finalizes GMP data integrity guidance
    • International – L’OMS publie son rapport mondial sur l’intelligence artificielle appliquée au domaine de la santé
    • International – ICH E17 Guideline on Multi-Regional Clinical Trials Catalyst for Simultaneous Global Development and Registration
    • International – Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)
    • International – PIC/S looks to adopt EU Annex on qualified persons, batch release
    • International – Let’s mix things up! Innovations in reconstitution technologies
    • International – ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards
    • International – International regulators and WHO address need to boost COVID-19 vaccine confidence
    • International – Les probiotiques dans la prévention du diabète sucré gestationnel
  • Catégorie : France
    • France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves
    • France – L’ANSM suspend la commercialisation des produits Trex Tea, Trex Caps et Trex Plus
    • France – Les contre-indications à la vaccination contre le Covid-19
    • France – Bronchiolite : Moderna annonce des résultats positifs pour son vaccin
    • France – Gustave-Roussy choisit Synapse Medicine pour sécuriser ses prescriptions complexes
    • International – Contre le Covid-19, l’exécutif mise aussi sur le Paxlovid, l’antiviral de Pfizer
    • France – Fiche bon usage des médicaments antiémétiques dans le traitement symptomatique des nausées et des vomissements
    • France – Sérialisation: vers une pénalité trimestrielle et reconductible de 2.000€ pour les officinaux
    • France – « Contre la résistance aux antibiotiques, la recherche et la production publiques de médicaments s’imposent »
    • France – Covid-19 : intégration du vaccin bivalent Spikevax® (BA.4-BA.5) dans la stratégie vaccinale
    • France – Le logiciel officinal Pharmony One obtient l’agrément Sesam-Vitale
    • France – Avis relatif à la couverture des besoins de la population générale en vitamine D et en fer
    • France – L’ANSM publie les nouvelles règles des bonnes pratiques de préparation
    • France – Virus de la variole du singe : recommandations pour sécuriser les dons de selles dans le cadre de la transplantation de microbiote fécal (TMF)
    • France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de vaccination pour l’automne
    • France – Accès précoce et compassionnel: les deux nouveaux référentiels de la Cnil attendus en septembre
    • France – Covid-19 : l’Agence européenne des médicaments autorise la mise sur le marché du vaccin de Valneva
    • France – Médicament: ouverture d’une plateforme de dépôt de dossiers auprès du CEPS
    • France – HAS : Monkeypox : la stratégie vaccinale réactive précisée pour les primo-vaccinés et les enfants
    • France – Lyon: ouverture d’un centre spécialisé dans la prise en charge des addictions aux médicaments
    • France – Covid-19 : la HAS se prononce en faveur du remboursement du Paxlovid®
    • France – Dominique Le Guludec nomme Fabienne Bartoli comme directrice générale
    • France – Paracétamol : des médecins découvrent un effet indésirable préoccupant
    • France – Covid-19 : levée de la contre-indication à la primovaccination après un PIMS
    • France – Covid-19 : la HAS rend trois nouveaux avis pour actualiser la stratégie de lutte contre le virus
    • France – Production et culture du cannabis à usage médical en France : l’ANSM engage les travaux pour définir les spécifications des médicaments à base de cannabis
    • France – Sérialisation: « environ 5.000 officines » connectées au répertoire national de vérification des médicaments (France MVO)
    • France – Médicaments : pourquoi Big Pharma veut sortir des produits grand public
    • France – Dépakine : Sanofi jugé responsable d’un manque de vigilance et d’information sur les risques
    • France – Variant Omicron: le Conseil scientifique recommande d’augmenter la dose de rappel de Moderna
    • France – Les antibiotiques sont-ils un traitement efficace contre la COVID-19 et provoquent-ils des effets indésirables ?
    • France – Décision n° 2021.0312/DC/SEM du 9 décembre 2021 du collège de la Haute Autorité de santé portant autorisation d’accès précoce de la spécialité EVUSHELD (tixagévimab/cilgavimab)
    • France – Décision n° 2021.0313/DC/SEM du 9 décembre 2021 du collège de la Haute Autorité de santé portant refus de la demande d’accès précoce de la spécialité LAGEVRIO (molnupiravir)
    • France – Dématérialisation des essais cliniques: vers une pérennisation de la pratique?
    • France – Cannabis médical : un écran de fumée ?
    • France – Livmed’s: la plateforme de livraison de médicaments boucle sa première levée de fonds
    • France – Vente en ligne de médicament: la France fait appliquer ses règles aux sociétés européennes
    • France – HAS : Stratégie de vaccination contre la Covid-19 – Place du vaccin à ARNm SPIKEVAX
    • France – E-Parcours: 257 projets financés pour 142 millions d’euros engagés au total (ministère)
    • France – Publicité et vente en ligne de médicament: l’UDGPO dénonce l’inaction des pouvoirs publics
    • France – Dose de rappel anti-COVID-19 : n’utiliser que le vaccin de Pfizer, recommande la HAS
    • France – Sérialisation: des sanctions contre les officinaux récalcitrants envisagées dans le PLFSS 2022
    • France – RGPD : Q & R
    • France – Publication des référentiels de certification des LAP hospitaliers et en ambulatoire (JO)
    • France – Antibiothérapie : La HAS revoit sa copie
    • France – Covid-19 : autorisation d’accès précoce accordée à un traitement prophylactique
    • France – En France, les prescriptions médicamenteuses chez les enfants se maintiennent à des niveaux élevés
    • France – L’ATIH lance une nouvelle application pour étudier la consommation de médicaments et DM
    • France – MaPUI Labs lance une plateforme numérique qui centralise les tensions et ruptures de stock de médicaments
    • France – Covid-19 : l’obligation vaccinale prévue par la loi est justifiée et son élargissement doit être débattu
    • France – Accès précoce à un médicament
    • France – Décision n° 2021.0169/DC/SEVOQSS du 24 juin 2021 du collège de la Haute Autorité de santé portant adoption du document Flash Sécurité Patient intitulé « Accidents liés à un médicament à risque : Qui dit potassium (KCl), dit vigilance maximale »
    • France – Rapport d’activité 2020 de la HAS
    • International – Study finds mixed vaccine schedules provide strong immune response against COVID-19
  • Catégorie : Europe
    • Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2)
    • Europe – EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
  • Catégorie : Amériques
    • USA – FDA issues draft guidance on dosage and administration labeling
    • Canada – La pilule anti-COVID de Pfizer approuvée par Santé Canada
  • Catégorie : Asie-Pacifique
  • Catégorie : Découverte
    • USA – 10-year study shows CAR T-cell therapy cured cancer in 2 patients
• Catégorie : DM-DIV
  • Europe – MedTech Europe’s vision for a resilient medical technology ecosystem
  • Australia – Phase out of ISO 13485 certificates for IVD medical devices
  • Europe – Euro Convergence: Experts call for more IVD-specific guidance during IVDR transition
  • Europe – UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR – May 2023
  • Europe – GUIDANCE on the content and structure of the summary of the clinical investigation report
  • USA – MedCon: Consider the device risk management file a ‘living document’
  • USA – FDA issues draft guidance on decentralized clinical trials
  • UK – Medical devices – extended acceptance of CE marked medical devices on the Great Britain market
  • Europe – Intellectual property: harmonised EU patent rules boost innovation, investment and competitiveness in the Single Market
  • Europe – Amendement des normes IEC 60601 : les impacts sur l’évaluation des DM
  • Europe – Transition to MDR underway for 63% of outgoing Directives certificates
  • USA – EPA proposes rules on EtO with implications for medical device sterilization
  • Switzerland – Switzerland, too, extends medical device certifications to safeguard supply
  • USA – FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
  • USA – FDA releases draft guidance for non-spinal orthopedic bone fixation devices
  • USA – Guidance gives FDA authority to reject devices due to poor cybersecurity
  • USA – FDA finalizes guidance allowing some contact lens sponsors 510(k) predicate leeway
  • UK – Extension of CE certificates
  • USA – FDA eases labeling, clarifies IVD requirements in COVID transition guidances
  • Europe – 38ème organisme notifié au titre du Règlement 2017/745 
  • Europe – Le règlement (UE) 2023/607
  • Europe – Publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook
  • USA – New rule directs mammography facilities to tell patients about breast density
  • Europe – Advisory group urges UK to ‘rapidly explore’ recognition of US device approvals
  • Europe – Council votes unanimously to extend MDR deadlines
  • USA – We keep trying to make AI therapists. It’s not working.
  • UK – Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU
  • Europe – La prolongation de la période de transition pour les dispositifs médicaux et les dispositifs médicaux de diagnostic in vitro est adoptée
  • Europe – Nouvel Organisme Notifié au titre du règlement (UE)2017/746
  • Europe – European Parliament votes to extend MDR transition period
  • Europe – MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices – February 2023
  • Europe – Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – February 2023
  • USA – Industry asks FDA to clarify voluntary malfunction reporting program requirements
  • Europe – EMA to launch scientific advice pilot for high-risk devices in late February
  • Europe – 37 ème organisme notifié au titre du Règlement 2017/745
  • USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products
  • USA – Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
  • Switzerland – Dealing with certification gaps (MDCG 2022-18)
  • USA – FDA final rule reduces radiological devices reporting requirements
  • USA – Advocacy groups, AdvaMed vie for next phase of TAP pilot
  • UK – MHRA increases UK assessment capacity for in-vitro diagnostic devices
  • USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’ for manufacturers
  • USA – FDA draft guidance covers low-level light therapy devices
  • Europe – MDCG 2023-2 List of standard fees
  • USA – FDA official says pandemic reauthorization bill could drive VALID across finish line
  • Europe – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • Europe – MDR transition delay needs clarification, industry engagement to succeed
  • Europe – Santé publique: plus de temps pour certifier les dispositifs médicaux afin de limiter les risques de pénuries
  • USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
  • USA – FDA classifies slew of class II devices following de novo procedures
  • USA – FDA opens TAP
  • UK – Exceptional use of non-UKCA marked medical devices
  • UK – Medical devices: UK approved bodies
  • USA – FDA guidance proposes devices be deemed adulterated for refusing inspections
  • USA – New US FDA Guidance on Human Factors Engineering for Medical Devices
  • Switzerland – Swiss Regulators Set To Recognize US FDA-Cleared or Approved Medical Devices
  • Europe – Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Revised)
  • Europe – MDCG 2022-4 Rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD (Revised)
  • Europe – MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to regulation (EU) 2017/745 (MDR)
  • Europe – MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
  • Europe – EU issues implementing regs for devices without an intended medical purpose
  • USA – FDA proposes framework for human factors information in device submissions
  • Europe – MDCG 2022-18 : Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
  • Europe – European Council members support proposal to delay MDR deadlines
  • USA – FDA aims to clarify device malfunction summary reporting requirements
  • USA – Switzerland eyes allowing FDA-approved medical devices onto its market
  • International – Medical devices 2030 : Making a power play to avoid the commodity trap
  • Europe – Artificial Intelligence Act : un nouveau règlement européen à suivre de près
  • UK – Borderline products: how to tell if your product is a medical device and which risk class applies
  • UK – Register medical devices to place on the market
  • USA – Theranos : onze ans de prison contre Elizabeth Holmes, patronne déchue, condamnée pour fraude
  • Taiwan – Taiwan’s MOHW issues draft revision of UDI requirements; draft amendment of the charge standards of administrative fees for medical devices
  • Europe – Accord avec le Royaume-Uni relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité
  • USA – FDA rules on definitions of device; issues revised form for reporting adverse events
  • Malaysia – MDA publishes draft guidance on notification of custom-made medical devices
  • Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)
  • USA – Industry seeks clarity, ICH Q9 alignment in FDA’s device production software guidance
  • Europe – European Notified Body survey: MDR, IVDR certification numbers remain low
  • USA – Quinze ans de prison requis contre Elizabeth Holmes, fondatrice de Theranos
  • Europe – Nanoparticle-based drug delivery systems
  • USA – Action needed on FDA regulation of AI-based medical devices
  • USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
  • USA – FDA updates guidance on identifying and responding to deficiencies
  • Europe – Notified bodies survey on certifications and applications
  • UK – New device launched for diagnosing prostate cancer
  • Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
  • USA – FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard
  • USA – FDA proposes updates to Breakthrough Devices Program guidance
  • UK – MHRA : Implementation of the Future Regulations
  • UK – Implementation of the future regulation of medical devices and extension of standstill period
  • USA – FDA issues road map to medical device regulatory guidance topics list for 2023
  • Europe – COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
  • USA – FDA proposes breakthrough status for devices that address health disparities
  • USA – FDA issues roadmap to medical device regulatory guidance topics list for 2023
  • USA – FDA launches TAP Pilot to speed access to safe and innovative medical devices
  • Europe – 34ème Organisme Notifié
  • USA – FDA device center guidance priority lists targets COVID, digital health
  • UK – Guidance : Software and AI as a Medical Device Change Programme
  • Australia – TGA set to accept medical device assessments from Singapore’s HSA
  • USA – FDA finalizes which clinical decision software functions it regulates
  • Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems
  • USA – FDA will begin accepting breakthrough devices for TAP pilot in 2023
  • USA – US FDA sets some steep increases for 2023 medical device user fees
  • UK – MHRA and NICE awarded £1.8m to explore regulation of digital mental health tools
  • USA – FDA finalizes guidances on device post-approval studies, postmarket surveillance
  • Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745
  • Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
  • Europe – « Le risque d’une pénurie de dispositifs médicaux fait craindre une nouvelle crise sanitaire »
  • USA – Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry
  • USA – FDA updates guidances to reflect new MDUFA goals
  • South Korea – South Korea rules on emergency production and distribution of medical products
  • USA – FDA acknowledges shortcomings of Pre-Cert pilot in report
  • USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
  • UK – MHRA appoints first new UK Approved Body to certify medical devices since Brexit
  • FDA seek to harmonize human subject protections with revised Common Rule
  • Singapore – HSA to commence Phase I implementation of UDI labeling in November 2022
  • USA – FDA wants COVID test developers to shift from EUAs to traditional premarket pathways
  • USA – New FDA guidance offers ethical roadmap for including children in clinical trials
  • China – Un robot miniature biodégradable pour l’administration ciblée de médicaments
  • UK – UK regulator MHRA to raise medical device registration and other fees by 10% or more
  • Spain – Des applis mobiles pour prédire le risque d’exacerbations de BPCO et détecter le Covid-19 grâce à la voix
  • France – Comment la médecine in silico peut accélérer l’innovation en matière de DM
  • Europe – MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
  • Brazil – ANVISA announces major medical device registration updates
  • USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
  • USA – FDA drafts guidance on device production and quality system software assurance
  • Europe – New European Manual on Borderline and Classification for medical devices and IVDs issued
  • USA – Patient preference information: Researchers offer insights on medical device clinical trial design
  • Australia – Update: Medical device UDI implementation, Essential Principles guidance
  • UK – Medical devices: UK approved bodies
  • Europe – New study shows pioneering test for endometrial cancer could significantly reduce diagnosis time
  • South Korea – Updates: Innovative device designations, IVD Act enforcement
  • India – Indian regulators add to list of medical device testing laboratories
  • Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) (deuxième avis)
  • Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) (première avis)
  • USA – FDA finalizes rule for over-the-counter hearing aid devices
  • China – Update: Class I medical device filing rules, UDI standards
  • USA – FDA: Nearly 700 breakthrough medical device designations since 2015
  • Europe – New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR
  • South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
  • China – Chinese regulators recommend clinical evaluation paths for certain medical devices
  • USA – FDA eases UDI compliance requirements for some low-risk medical devices
  • South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
  • Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR
  • Japan – Japan updates guidance on QMS Conformity Survey applications
  • Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)
  • Singapore – Singapore adds HIBCC to list of UDI issuing agents
  • Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey
  • India – India issues new draft IVD rules and updated classifications for rehab devices
  • Australia – Australia updates guidance on implantable medical devices, required six-monthly report
  • UK – E-cigarettes: regulations for consumer products
  • China – NMPA rules on medical device naming, QMS inspections and industry standards
  • Italy – The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
  • Europe – Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
  • UK – What will the UK MHRA consultation bring in terms of medical device and IVD regulations?
  • Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private health insurance rules for prostheses
  • UK – UK to strengthen regulation of medical devices to protect patients
  • USA – FDA finalizes guidance on machine learning for medical devices
  • France – Une appli mobile pour accompagner les soignants dans la prise en charge des plaies chroniques et/ou complexes
  • Europe – Questions and Answers on Certificates of Free Sale and Article 60 of Regulation (EU) 2017/745 on medical devices (MDR)
  • Europe – CAMD Statement – 50th CAMD Plenary meeting
  • South Korea – South Korea updates regulations on medical device codes and classification
  • USA – FDA takes a step forward for machine learning with quantitative imaging guidance
  • Japan – Japan’s medical device regulators update PMD Act and the online submissions process
  • UK – MHRA joins international partnerships to set global standards for medicines and medical devices regulation
  • USA – La FDA planche sur des directives relatives à la sécurité des objets connectés de santé
  • China – Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific guidelines and technical review points
  • Europe – MDCG 2022-11 MDCG Position Paper Notice to manufacturers to ensure timely compliance with MDR requirements
  • USA – US FDA withdraws COVID-era guidance for medical device and IVD market approval processes
  • Europe – EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation
  • Europe – Exercer la fonction de PCVRR : où en sommes-nous aujourd’hui ?
  • USA – FDA considers pilot for lower radiation levels for device sterilization
  • Europe – New Swiss IVD regulations come into force as EU mutual recognition agreement expires
  • Australia – Process chart: Australia TGA regulatory approval for medical devices
  • India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses
  • Europe – Artificial intelligence in healthcare
  • USA – FDA adds transition period to electromagnetic compatibility final guidance
  • USA – Pre-submission requests for IVDs to be accepted by FDA
  • Europe – MDR/IVDR: Commission seeks comment on revisions to standardization request
  • Europe – New guidance from European MDCG ahead of date of application
  • Europe – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials
  • Australia – Update: TGA defines which digital mental health software it regulates
  • Europe – IVDR implementation day overshadowed by lack of notified bodies, risks to patients
  • Europe – SSCP expert lists common mistakes device manufacturers make
  • Europe – MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
  • Brazil – ANVISA extends Brazilian Good Manufacturing Practice requirements to more medical device manufacturers
  • Europe – MDCG 2022-9 Summary of safety and performance Template
  • Europe – MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
  • Europe – Uniformiser le processus d’enregistrement des DM à l’échelle de la planète
  • Europe – IVDR Watch: European regulators add ISO 14971 to harmonized standards list
  • Europe – TUV NORD Polska New Notified Body Designated Under MDR
  • Europe – UDEM Adriatic d.o.o. New Notified Body Designated Under MDR
  • Europe – MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • UK – What do companies supplying IVDs to the UK market need to know about the IVDR?
  • USA – FDA asks manufacturers to develop risk management plans to avert shortages
  • Brazil – Brazil’s ANVISA repeals medical device regulations related to the coronavirus pandemic
  • Europe – Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
  • USA – FDA moves forward with Voluntary Improvement Program to bolster medical device quality
  • UK – Medical devices: UK approved bodies
  • Europe – IVDR: Commission adds risk management standard to harmonized standards list
  • Singapore – Singapore issues new guidance for software as a medical device
  • USA – Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device
  • Europe – Machine Learning-enabled Medical Devices: Key Terms and Definitions
  • Europe – IMDRF: Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form
  • Europe – Compliance for medical device makers in the EU and Turkey just got easier
  • India – India’s DCGI adds more medical device testing laboratories
  • Europe – MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
  • USA – FDA drafts guidance on medical device voluntary improvement program
  • USA – First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing
  • Europe – 3EC International becomes seventh Notified Body designated under EU IVDR
  • Europe – Implementing the Medical Devices Regulation (MDR)
  • Europe – MDCG 2022 – 5 : Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
  • Australia – TGA publishes latest medical device application processing times
  • USA – FDA warns that some prenatal screening tests can generate false results
  • Europe – UDI Devices – User guide
  • USA – FDA offers guidance on waiver requests for pH adjusters
  • USA – FDA recommends sponsors plan to include race, ethnicity in clinical trial design
  • Brazil – Brazilian regulators update Good Manufacturing Practices for medical devices and IVDs
  • Australia – TGA expectations for transition to 2021 Advertising Code and updated guidance on reclassification of AIMDs
  • USA – FDA finalizes two more safety and performance based pathway guidances
  • China – Medical Device Classification Catalogue, manufacture and distribution rule revisions
  • USA – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
  • USA – FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances
  • Europe – Update : Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
  • UK – NHS develops world-first bedside genetic test to prevent babies going deaf
  • Europe – MedTech Europe updates ethical code
  • USA – Commenters seek improvements in FDA’s computational modeling draft guidance
  • Australia – Australian reforms to Prostheses List may affect medical device reimbursements
  • Brazil – Brazil’s ANVISA issues registration rules for software as a medical device (SaMD)
  • USA – RF Quarterly, April 2022: Software as a medical device
  • USA – Clinical evaluation of software
  • UK – ICR scientists create AI test to predict cancer drug combinations
  • UK – NICE recommends flash devices to type 1 diabetes patients
  • USA – MDUFA V: US FDA sets performance goals for De Novo medical device reviews
  • USA – Strengthening supply chains to mitigate medical device shortages
  • USA – Stakeholders ask for more time to transition EUA devices, diagnostics
  • USA – Digital human factors engineering platform now available for medical device manufacturers
  • Asia – Asia-Pacific Roundup: India consults on voluntary medical device marketing code
  • USA – Report: Using RWD to evaluate AI-enabled clinical decision support tools
  • USA – US FDA Cybersecurity Alert: Risks found in medical device software components
  • China – China regulatory roundup: Latest guidelines for medical device and IVD compliance
  • USA – FDA slams California company for selling brain devices without approval
  • Europe – European IVDR resource center: Prepare for compliance
  • USA – US FDA recommendations for voluntary recalls of medical devices and products
  • USA – Quality System Regulation Amendments – Frequently Asked Questions
  • Europe – Arrêté du 4 mars 2022 fixant la charte de qualité des pratiques professionnelles des personnes chargées de la présentation, de l’information ou de la promotion des dispositifs médicaux à usage individuel, des produits de santé autres que les médicaments et des prestations de service éventuellement associées
  • International – Researchers develop portable device to detect Parkinson’s
  • USA – FDA OKs drug-eluting contact lens from J&J Vision
  • USA – How long is the FDA review process for 510(k) medical device submissions?
  • USA – This Week at FDA: HHS delays SUNSET rule, FDA begins release of Comirnaty review docs, and more
  • USA – FDA calls on firms to be ‘recall ready’ in final guidance
  • USA – QMSR: Industry wants to avoid ISO 13845 ‘plus,’ seeks longer transition period
  • UK – UK approved bodies for medical devices
  • USA – Digital smoking treatment device gets breakthrough status
  • USA – FDA offers guidance on patient-focused product development
  • USA – Device companies urge FDA to refine guidance on PCLC devices
  • USA – QMSR: FDA previews questions ahead of device GMP adcomm
  • USA – US FDA formally proposes aligning Quality System Regulations with ISO 13485
  • Singapore – Singapore’s HSA issues new rules affecting COVID-19 tests
  • USA – FDA Roundup: February 22, 2022
  • USA – QSMR: FDA proposes QSR overhaul after years of delays
  • Canada – Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19
  • Europe – MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR
  • Europe – MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies
  • South Korea – South Korea plans partial amendments to rules on medical device manufacturing license renewals
  • India – India issues draft rules for medical device and IVD registration certificates
  • USA – 3D printing medical devices: Stakeholders weigh in on FDA’s discussion paper
  • Switzerland – Selon SWISS MEDTECH la Commission européenne viole le droit existant
  • USA – Device group urges FDA to refine software function guidance
  • Japan – New guidelines from Japanese regulators cover medical device cybersecurity, remanufactured devices and MDSAP reports
  • USA – US FDA roundup: Final rules for combination products, patient reports for medical device evaluation, patient input on clinical studies
  • Europe – IVDR watch: Updated Joint Implementation Plan targets risk of IVD shortages
  • USA – FDA OKs personal, Bluetooth-enabled ECG device
  • Malaysia – Malaysian regulators update MedC@st electronic medical device registration system
  • USA – US FDA rolls out notification requirements to protect medical device supply chains
  • USA – FDA: Device breakthrough program surpassed expectations, while novel device authorizations fell in 2021
  • International – Un ordinateur médical qui permet de protéger les nerfs
  • France – Vers un pansement libérant un agent antimicrobien si besoin
  • Europe – L’UE et la Suisse prennent des chemins différents sur la question des DM
  • France – Les dangers liés au MDR : la profession tire la sonnette d’alarme !
  • Europe – MDCG 2022-2 : Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
  • Europe – Règlement (UE) 2022/112 modifiant le règlement (UE) 2017/746
  • USA – FDA finalizes guidance on premarket review of combination products
  • Brazil – Brazilian regulators to allow sales of COVID-19 self-test kits to consumers
  • USA – COVID-19 pauses US FDA inspection plans, again
  • USA – Final FDA guidances focus on improving device trials
  • Europe – European Notified Bodies issue updates on MDR, IVDR implementation challenges
  • India – Indian regulators delay implementation of UDI for medical devices
  • Europe – MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
  • Europe – European Parliament endorses legislation bolstering EU’s ability to tackle shortages
  • USA – CDRH outlines plan to understand sex and gender differences in medical devices
  • USA – FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women
  • UK – Medical devices given exceptional use authorisations during the COVID-19 pandemic
  • USA – This Week at FDA: User fee update, Califf nomination…
  • Europe – Prothèses mammaires PIP : le certificateur TÜV Rheinland doit indemniser 1 600 nouvelles plaignantes
  • Europe – New Notified Body designated to IVD Directive in Europe
  • USA – US FDA lays out post-COVID EUA transition plans for medical devices
  • USA – Draft Guidance : Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  • Europe – IVDR: European Commission publishes second batch of harmonized standards
  • USA – FDA seeks comment on device shortage reporting guidance
  • USA – FDA issues draft guidance on assessing physiologic closed-loop control devices
  • Europe – European Commission publishes second batch of harmonized standards under MDR
  • Europe – Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials
  • USA – New blood test can identify presence of cancer
  • USA – Computational modeling and simulation: FDA outlines framework for assessing credibility
  • Switzerland – Medical device direct imports to users in Switzerland
  • UK – The past, the present, and the future of clinical trials transparency in the UK
  • USA – Covid-19 : les tests antigéniques seraient moins sensibles au variant Omicron
  • USA – New Sterilization Technology Offers an Alternative to EtO
  • Europe – EU IVDR Readiness Assessment Checklist
  • Europe – European IVDR application partially postponed
  • France – Inventer l’équivalent du pacemaker pour le cerveau
  • China – Première angioplastie coronaire avec l’assistance du robot R-One en Chine
  • Europe – Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation
  • Europe – Annex XIV of the European MDR and clinical development plans for medical devices
  • UK – Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
  • Europe – EC outlines rules for electronic IFU for med devices
  • USA – Un algorithme associé aux montres connectées Fitbit apparaît fiable pour détecter la fibrillation atriale en population générale
  • USA – Discussion Paper: 3D Printing Medical Devices at the Point of Care
  • USA – Pharma, device groups oppose FDA’s planned drug to device transition
  • USA – Groups request clarifications to safety reporting draft guidance
  • UK – Marketing authorisation acquired for first and only transdermal contraceptive patch in UK
  • Europe – MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • Europe – MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation
  • Japan – Japan PMDA updates MDSAP policies ahead of 2022 implementation deadlines
  • Canada – Canadian regulators issue new reporting requirements for medical device shortages
  • USA – FDA expands eSTAR filing to de novo devices, IVDs
  • UK – Le groupe LNE crée une filiale de GMED au Royaume-Uni
  • Europe – Commission Européenne 25ème organisme notifié au Titre du Règlement (UE) 2017/745
  • Europe – EUDAMED : Règlement d’Exécution (UE) 2021/2078
  • Europe – Droit et éthique des DM à base d’IA : l’Europe et la France accélèrent !
  • Australia – Australian regulators plan up-classification of medical devices targeting circulatory, nervous systems
  • Australia – Australia Regulatory Roundup: medical device clinical evidence, reclassification, post-market monitoring
  • France – Le CHU de Clermont-Ferrand intègre le laboratoire de recherche SimatLab
  • USA – FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II
  • Europe – List of views provided and ongoing consultations under the PECP
  • USA – Industry, clinician groups have different wish lists for AI/ML-enabled device labels
  • Europe – Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
  • China – IVD classification rules, medical device self-testing requirements
  • France – Forum sur l’évaluation de l’IA, le 24 novembre à Paris
  • Australia – Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin
  • Europe – Que disent les règlements européens sur les DM face aux défis de l’IA ?
  • Europe – Outil de filtrage pour le règlement européen sur les DMDIV
  • Australia – Software for use with COVID-19 rapid antigen self-tests
  • International – Robotic Surgery Ecosystem: The path to democratize surgery
  • Europe – Deal on stronger role for EU medicines regulator
  • India – Indian regulators propose easing ISO 13485-related requirements for medical device registrants
  • USA – FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
  • USA – FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
  • USA – CDRH outlines guidance plans for FY2022
  • International – Bandage can monitor chronic wounds
  • Europe – MDCG 2021-25 : Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
  • USA – Defining critical tasks for human factors validation tests of combination products
  • USA – FDA issues proposed OTC hearing aid rule
  • USA – FDA says IRB review still needed for IVD studies involving human specimens
  • UK – MHRA launches public consultation on future of medical device regulation
  • Europe – European IVDR application partially postponed
  • USA – FDA nixes GUDID submission requirements for class I consumer healthcare devices
  • Europe – IVDR: Commission proposes to delay implementation amid ‘grave’ notified body shortage
  • USA – Microspheres for knee osteoarthritis get breakthrough status
  • Europe – Eudamed update: Additional data entry modules now online for European medical device, IVD registrants
  • Japan – Japanese regulators extend Medical Device Single Audit Program (MDSAP) pilot
  • Australia – Classification of active medical devices (including software-based medical devices)
  • USA – FDA reclassifies surgical staplers, staples after review links devices to injuries and deaths
  • Europe – MDCG 2021-24 : Guidance on classification of medical devices
  • USA – FDA finalizes long delayed de novo classification rule
  • Australia – Australian regulators plans up-classification of medical devices targeting circulatory, nervous systems
  • USA – FDA drafts safety reporting guidance for drug and device investigators
  • UK – Borderlines with medical devices and other products in Great Britain
  • UK – MHRA shares guidance on need to review registration of medical devices
  • USA – US FDA rolls out list of registered medical devices featuring artificial intelligence and machine learning
  • USA – FDA issues draft guidance on electronic 510(k) submissions
  • International – Asia-Pacific Roundup: TGA posts guidance on reclassification of certain implantable devices
  • USA – FDA publishes first batch of device material safety reports in ECRI partnership
  • USA – FDA Authorizes Software that Can Help Identify Prostate Cancer
  • USA – FDA OKs new pathology AI software, launches AI-enabled device database
  • Australia – Reclassification of spinal implantable medical devices
  • Australia – Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems
  • France – La FDA se réorganise et crée un  »bureau de la transformation numérique »
  • India – Indian regulators publish new classification lists for medical device registrants
  • Australia – Australia TGA to accept CE Mark conformity assessments for some high-risk medical devices, IVDs
  • Australia – Software for use with COVID-19 rapid antigen self-tests
  • UK – Transforming the regulation of software and artificial intelligence as a medical device
  • UK – MHRA launches public consultation on future of medical device regulation
  • Europe – IVDR watch: IVD Expert Panel now accepting submissions for performance evaluation consultations
  • Australia – Conformity assessment certificates, changes to requirements for certain medical devices
  • Japan – Convergence: First-year experience with Japan’s amended medical device rules
  • Singapore – Singapore HSA recommends cybersecurity protections against BrakTooth for Bluetooth medical devices
  • Europe – Le TUV Rheinland Italia SRL, 23ème ON habilité au titre du RDM
  • USA – FDA outlines safety and performance-based criteria for facet screw systems and denture base resins
  • Singapore – Singapore HSA finalizes Unique Device Identification (UDI) requirements for medical devices
  • USA – Vagal nerve stimulator for stroke rehab nabs FDA nod
  • UK – Register medical devices to place on the market
  • Europe – Proposal for an Artificial Intelligence Act (COM/2021/206) – MedTech Europe response to the open public consultation
  • China – Chinese regulators revise drug-device combination product registration requirements
  • UK – UKCA marking delay: What it means for medical device and IVD manufacturers
  • Europe – MDCG 2021- 23 : Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • USA – FDA updates safety communication for robotically assisted surgical devices used in mastectomy
  • Europe – MDCG 2021-22 : Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
  • USA – FDA affirms increased risk with pelvic mesh products
  • USA – Update: Check first with FDA regarding their current availability to review a human factors validation test protocol
  • USA – Update: FDA is not accepting human factors validation test protocols for review until further notice
  • South Korea – South Korea MFDS plans several medical device regulatory updates for 2022
  • USA – Proposed US FDA program targets medical device supply chain shortages
  • Europe – Notified bodies report success — and some drawbacks — using remote audits
  • Brazil – Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers
  • UK – Post-Brexit medical device and IVD oversight: A new plan for the UK MHRA
  • Europe – CARMAT : annonce la première implantation humaine de son cœur artificiel Aeson® en Allemagne
  • Australia – Is my software regulated?
  • Australia – TGA international engagement strategy 2021-2025
  • Taiwan – Final exemption list, cybersecurity guidelines, COVID-19 measures and more (Update)
  • Europe – “UE for PDC”: Little bits of usability engineering for platform-device companies
  • USA – CDRH official offers advice for smoother Q-submission meetings
  • USA – FDA seeks expanded authority to boost device supply chain
  • Europe – Team-NB Position Paper on “implant card”
  • Europe – MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations
  • Europe – 22ème ON vient d’être notifié au titre du règlement UE 2017/745. Il s’agit d’Eurofins Italy
  • Europe – New guidelines published on integrating UDI into quality management systems under MDR, IVDR in Europe
  • Singapore – Singapore HSA holds consultation on SaMD classification draft guidance
  • China – China NMPA seeks feedback on optimization of medical device standards
  • UK – The Medical Devices (Amendment) (EU Exit) Regulations 2021
  • Asia – Asia-Pacific Roundup
  • France – Simulations biomécaniques : l’avenir de l’ingénierie médicale
  • Australia – Consultation: Proposed refinements to the regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin
  • Europe – MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system
  • Europe – KIWA (Italy) – 21ème ON au titre du RDM
  • Asia – Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies
  • Europe – MDCG 2021-14 Explanatory note on IVDR codes
  • Europe – Euro Roundup
  • USA – FDA finalizes long-awaited UDI guidance
  • USA – US FDA revokes Emergency Use Authorizations (EUA) for some personal protective equipment (PPE)
  • Europe – Loi Jardé et Règlement (UE) 2017/745 : le point sur la matériovigilance
  • Europe – Le premier avis des groupes experts scientifiques dans les domaines des DM est publié :
  • UK – Freedom of Information responses from the MHRA – week commencing 3 May 2021
  • Europe – ANSM – Dispositions nationales relatives à l’enregistrement des DM dans l’attente de la mise à disposition d’EUDAMED
  • USA – FDA report examines use of patient experience data in decision-making
  • USA – US FDA aims to improve cybersecurity related to servicing and maintenance of medical devices
  • Singapore – Singapore HSA explains new developments for COVID-19 test kit authorizations
  • Europe – Conseil et Parlement Européen : projet de renforcement du rôle de l’EMA relatif aux médicaments et DM
  • Europe – MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
  • Europe – Clinical performance studies with companion diagnostic (CDx) devices
  • Europe – Health Technology Assessment: Informal deal between Council and European Parliament
  • Europe – Mon logiciel est-il un dispositif médical en vertu du règlement européen ?
  • USA – FDA explains when device ‘servicing’ becomes ‘remanufacturing’
  • China – Chinese regulatory bodies provide updates on revised medical device regulations
  • Europe – European Medical Device Nomenclature (EMDN) : Q & A
  • Singapore – COVID breathalyzer tests win provisional authorization in Singapore
  • Europe – Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID
  • USA – Testing for Biotin Interference in In Vitro Diagnostic Devices
  • Europe – IVDR: MDCG charts rollout in new implementation plan
  • Europe – IVDR : la date d’application sera-t-elle repoussée ?
  • Europe – May’s Regulatory Focus: EU MDR and EU IVDR update, and more
  • Australia – Australian Conformity Assessment Body (AU CAB) applications begin in July
  • Europe – IVD devices: From performance evaluation studies to clinical performance studies, what has changed?
  • UK – Using the UKCA marking
  • Europe – MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN)
  • Europe – MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
  • Europe – Euro Roundup: Switzerland moves to mitigate split from EU on device regulation
  • USA – FDA authorizes new device to help diagnose pediatric autism
  • USA – US FDA considers updating labeling requirements for medical implants with metal components
  • Singapore – Singapore HSA releases draft guidance on medical device UDI system
  • Catégorie : International
    • International – Diabète : un pansement intelligent pour soigner et cicatriser les plaies chroniques
    • International – IMDRF guidances address cybersecurity, personalized devices and surveillance
    • International – IMDRF guidance aims to harmonize, streamline review reports
    • International – IMDRF publishes updated guides covering governance activities and membership
    • International – Enfin une norme internationale sur le dosage des EEB spécifique aux DM !
    • Israel – New study use musical tests for early detection of cognitive decline
    • International – MDSAP policy for remote quality system audits to expire in September 2022
    • South Africa – South African regulators issue guidance for medical device imports, advertising
    • Saudi Arabia – Saudi FDA postpones Unique Device Identification compliance deadlines
    • International – Des valves cardiaques imprimées en 3D
    • International – IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback
    • International – Révision de la norme ISO 10993-17 : quelles évolutions ?
    • International – Le CES et la Banque mondiale mettent la santé des femmes à l’honneur
    • International – Regulators issue Good Machine Learning Practice guiding principles for AI/ML medical device development
    • International – Du matériel médical conçu pour l’homme blanc
    • International – Recommandation sur l’éthique de l’intelligence artificielle
    • International – FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice
    • Saudi Arabia – Saudi FDA extends deadlines for Unique Device Identification compliance
    • International – Eurasian Economic Union revises medical device registration system
    • International – Bandes ou bas de contention : Le doute subsiste
    • International – Covid-19 : quelle protéine virale les TROD doivent-ils cibler en sérologie pré-vaccinale ?
    • International – Hydrogel brain implant mimics brain tissue
    • International – Blood test monitors ACE2 protein in COVID-19 patients
    • Saudi Arabia – SFDA revises guidance on storing and transporting medical devices
    • International – La Norme ISO 9001 ne sera pas révisée
    • International – Use Errors Part 2: Estimating the severity of potential harms
    • International – Benefits risks of Artificial Intelligence
    • International – Norme ISO 10993-23:2021 : quels impacts sur les essais d’irritation ?
    • International – ISO 20916: IVD medical device clinical performance studies at a glance
    • International – Estimating the likelihood of a use error: Part 1
    • International – Nouvelles Normes ISO pour les Dispositifs Médicaux
    • International – Chaussettes de compression dans le prévention de la thrombose veineuse profonde (TVP) chez les personnes voyageant en avion
  • Catégorie : France
    • Rencontrez l’équipe White -Tillet à Medi’Nov Connection du 31 mai au 1er juin 2023
    • France – France Biotech dévoile la dernière édition de son Panorama HealthTech
    • France – Choisir une méthodologie statistique pour l’évaluation clinique d’un DM
    • France – Solutions d’informatique embarquée pour les DM à base d’IA
    • France – Consultation publique sur le guide d’aide au choix des dispositifs médicaux numériques à usage professionnel
    • France – Radiation de 2 DM essentiels dans la prise en charge de l’AVC et de la maladie coronarienne
    • France – Arrêté du 22 février 2023 portant approbation du référentiel d’interopérabilité et de sécurité des dispositifs médicaux numériques
    • France – Fonctionnaliser des DM implantables grâce au CO2 supercritique
    • France – Dispositifs médicaux numériques : liste des activités de télésurveillance
    • France – Télésurveillance médicale : 2 décrets actent l’intégration de la télésurveillance médicale dans le droit commun
    • France – Ensinger Machining utilise hyperMILL pour usiner le cœur artificiel Carmat
    • France – Un point sur le remboursement des DM de télésurveillance
    • France – Dispositifs médicaux numériques à usage professionnel
    • France – Études en vie réelle – Recensement des sources de données mobilisables pour répondre aux demandes de la HAS
    • France – Lancement de l’Agence de l’innovation en santé
    • France – Sécurité: la base de données médicales Claude Bernard décroche la certification ISO 13485
    • France – Respirateurs Philips défectueux : un problème connu dès 2016 ?
    • France – Alzheimer: intérêt d’un algorithme d’apprentissage profond appliqué à la rétinographie
    • France – La Société française de dermatologie appelle les autorités à réglementer l’usage de l’IA
    • France – Surveillance des infections associées aux dispositifs invasifs en 2020
    • France – HAS: Vers un cadre commun d’évaluation des dispositifs médicaux numériques en Union européenne – Lancement d’une taskforce européenne
    • France – Intelligence Artificielle et DM : le brouillard des règles à appliquer
    • France – Une approche des études PMCF alliant IA et données de vie réelle
    • France – Concevoir un dispositif médical conformément à l’ISO 13485:2016
    • France – HAS – CNEDiMTS : DEPREXIS (thérapie numérique): service attendu suffisant dans la dépression légère
    • France – Comité d’interfaces ANSM/Industrie DM-DIV -Juin 2022) – 2
    • France – Comité d’interfaces ANSM/Industrie DM-DIV -Juin 2022) – 1
    • France – Plusieurs défis à relever pour assurer la sécurité des DM connectés (Afib)
    • France – Réévaluation des défibrillateurs cardiaques automatiques implantables avec sonde(s) endocavitaire(s)
    • France – Les logiciels de diagnostic in vitro : Nouveautés introduites par le Règlement (UE) 2017/746
    • France – Cybersécurité des DM et DMDIV
    • France – France 2030: 14 lauréats pour l’appel à manifestation d’intérêt « Santé numérique »
    • France – Comment apporter une preuve clinique suffisante pour se conformer au RDM ?
    • France – La medtech Dessintey dévoile sa nouvelle thérapie numérique de rééducation motrice
    • France – ANSM authorizes production of drug delivery device under old directive
    • France – Publication du référentiel d’interopérabilité et de sécurité des DM de télésurveillance
    • France – Arrêté du 25 juillet 2022 portant approbation du référentiel d’interopérabilité et de sécurité des dispositifs médicaux numériques de télésurveillance
    • France – Emballages de dispositifs médicaux : le LNE accrédité Cofrac
    • France – Un système innovant pour l’administration du nez vers le cerveau de médicaments biologiques chez les nouveau-nés
    • France – La HAS expérimente l’évaluation médico-économique des dispositifs médicaux numériques
    • France – Rapport d’activité 2021 de la HAS
    • France – Un risque réel de pénurie de Dispositifs Médicaux
    • France – Ethypharm lance la première thérapie numérique dans la dépression sans attendre son éventuel remboursement
    • France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs
    • France – Implants Essure® : l’étain mis en cause dans la toxicité du dispositif
    • France – HAS : LPPR : Dépôt d’un dossier auprès de la Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS)
    • France – Seringue préremplie connectée au moyen d’un tag NFC
    • France – LA HAS reconnait l’efficacité et l’utilité (ASA IV) du verre MiYOSMART (HOYA VISION CARE FRANCE) pour freiner la progression de la myopie
    • France – Le Snitem et le BVMed alertent les autorités sur les risques liés au RDM
    • France – Nanomatériaux : des exigences particulières pour les dispositifs médicaux
    • France – Arrivée en France des stylos à insuline connectés de Novo Nordisk
    • France – ANSM et industries des DM-DMDIV : Compte-rendu de la séance du jeudi 2 décembre 2021
    • France – Intelligence artificielle : la CNIL publie un ensemble de ressources pour le grand public et les professionnels
    • France – La nouvelle réglementation européenne fait grincer les dents du secteur du dispositif médical
    • France – Neovasc Reducer : Premier dispositif médical pris en charge dans le cadre du dispositif de prise en charge transitoire
    • France – Tests COVID-19 : un point sur la règlementation à l’approche du 26 mai
    • France – « Percée » du numérique dans la filière française des dispositifs médicaux (Snitem)
    • France – Endométriose : un test salivaire pour le diagnostic précoce
    • France – Covid-19 : la HAS rend trois nouveaux avis pour actualiser la stratégie de lutte contre le virus
    • France – Insuffisance respiratoire chronique: le télésuivi utile pour repérer les patients mal ventilés mais à améliorer
    • France – Appareils de ventilation Philips : l’ANSM souhaite contraindre Philips à accélérer le remplacement des appareils défectueux
    • France – Jamais sans mes nanoparticules magnétiques
    • France – La HAS retoque la demande de prise en charge transitoire de la psychothérapie numérique Deprexis
    • France – Mise en place du suivi des dispositifs médicaux inscrits sur la liste intra-GHS
    • France – Des fibres optiques assez souples pour guider la lumière dans le corps humain
    • France – COVID -19 : la HAS recommande d’étendre l’usage des autotests pour les personnes contacts vaccinées
    • France- Arrêté du 25 octobre 2021 fixant le règlement intérieur type des comités de protection des personnes
    • France – Les autotests devraient bientôt être gratuits pour les vaccinés
    • France – Jeux sur ordonnance: Kiplin décroche la certification « dispositif médical »
    • France – Dématérialisation des essais cliniques: vers une pérennisation de la pratique?
    • France – HAS – IRM : Un nouveau guide pour renforcer la sécurité des patients porteurs de dispositifs médicaux implantés
    • France – Les enjeux de l’évaluation des impacts organisationnels pour les DM
    • France – Évaluation de la compatibilité IRM des dispositifs médicaux implantables par la CNEDiMTS
    • France – La France va permettre un accès rapide au marché pour les developpeurs d’applis de santé
    • France – L’Institut Curie s’apprête à passer à l’analyse par IA de toutes les lames de cancer du sein
    • France – ANSM : Évolution règlementaire impactant les dispositifs médicaux qui contiennent du cobalt
    • France – Appel à projets de 100 millions d’euros sur l’évaluation des DM numériques ou à base d’IA
    • France – Le Système En Boucle Fermée Hybride Dblg1 Diabeloop, Enfin Remboursé !
    • France – Gestion des déchets issus des équipements électriques ou électroniques associés aux dispositifs médicaux perforants utilisés par les patients en auto-traitement et les utilisateurs d’autotest : nouveau décret
    • France – RGPD : Q & R
    • France – Études en vie réelle pour l’évaluation des médicaments et dispositifs médicaux
    • France – Cobaz DM : un outil dédié pour accéder aux normes et réglementations
    • France – DM connectés : des DM comme les autres au regard de la réglementation ?
    • France – GMED désigné au titre du Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro
    • France – L’ATIH lance une nouvelle application pour étudier la consommation de médicaments et DM
    • France – Nouveau règlement européen et avis aux demandeurs d’avis scientifique pour tout dispositif médical incorporant une substance médicamenteuse
    • France – Dispositifs médicaux qui imitent des médicaments : un marché peu contrôlé
    • France – L’analyse optique de surface 3D appliquée aux prothèses
    • France – Carmat annonce avoir vendu son cœur artificiel pour la première fois, en Italie
    • France – La HAS publie un référentiel d’évaluation du contenu médical des applications mobiles utilisable pour l’ENS
    • France – Données de vie réelle: un potentiel reconnu pour l’évaluation des produits de santé, des biais en embuscade (Afcros)
    • France – Création d’un traitement de données relatif aux autotests de dépistage du Covid-19 (décret)
    • France – CSIS 2021 : des annonces saluées par la profession
    • France – ANSM : rediffusion d’un webinaire sur le RDM en accès libre
    • France – Rapport d’activité 2020 de la HAS
    • France – Covid-19 : quelle utilité aujourd’hui pour les tests sérologiques ?
  • Catégorie : Europe
    • Europe – Team-NB : Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
    • Europe – Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation
    • Europe – European Regulators Move to Increase Notified Body Capacity
    • Europe – Nouvel Organisme Notifié au titre du règlement (UE)2017/746
    • Europe – Votre avis sur l’extension de la période de transition des RDM et RDMDIV ?
    • UK – Artificial pancreas technology set to change lives
    • Europe – The designation of notified bodies under the upcoming Artificial Intelligence Act
    • Europe – European Commission Proposes Extending MDR, IVDR Transition Periods
    • Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’
    • Europe – Cyber Security
    • Europe – Notified bodies’ paper on the application of hybrid audits to quality management system assessments under MDR/IVDR
    • Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs
    • Europe – Commission publishes implementing regulation on specifications for class D diagnostics
    • Switzerland – Switzerland joins EU in bringing in new IVD requirements to improve patient safety
    • Europe – IVDR Watch: European regulators update SSCP rules, high-priority implementation actions and technical documentation guidelines
    • France – Diabète: lancement de FreeStyle Libre 3, plus petit et connecté automatiquement au téléphone du patient
    • Europe – Intégrer design et aptitude à l’utilisation dans le développement d’un DM
    • Europe – RDM : que faut-il retenir pour l’UE et quels impacts hors Europe ?
    • Europe – MDCG 2021-11 Guidance on Implant Card – ‘Device types’
  • Catégorie : Amériques
  • Catégorie : Asie-Pacifique
    • Japan – Japan’s MHLW updates medical device program display code and labeling laws
  • Catégorie : Découverte
    • France – Longue vie aux implants électroniques
• Catégorie : Cosmétiques
  • Catégorie : France
    • France – L’ANSM suspend la commercialisation de produits cosmétiques de la marque Joëlle Ciocco Paris
    • France – Coptis propose une nouvelle base de données réglementaires
    • France – La FEBEA fait ses propositions aux candidats à la Présidentielle
    • France – Utilisation de l’argument de « neutralité carbone » dans les communications
    • France – Cosmétiques et réglementations environnementales : maitrisez vos échéances !
    • France – Biodiversité : La FEBEA publie un guide des bonnes pratiques
    • France – 40% des Français n’utilisent pas assez ou pas du tout de protection solaire lorsqu’ils sont exposés plusieurs heures au soleil
    • France – Gels hydroalcooliques : s’assurer de leur efficacité face au coronavirus
    • France – Une nouvelle étude confirme l’innocuité totale des soins solaires BIO
  • Catégorie : Europe
    • Europe – Règlement 2022/1181 : nouvelles règles d’étiquetage pour les produits contenant des libérateurs de formaldéhyde
    • Europe – Cosmetics Europe veut un Règlement cosmétique basé sur la science
    • Europe – Upcoming changes to REACH information requirements
    • Europe – Group assessment of bisphenols identifies need for restriction
    • Europe – Pharmaceutical industry provides unpublished data on chemical substances
    • Europe – Projet of transfert du SCCS Sous la responsabilité de l’ECHA : COSMED pointe les risques
    • Europe – Natural and organic cosmetics: An overview of certification options
    • Europe – SCCS – Request for a scientific opinion on the hair dye ‘Sodium Bromothymol Blue (C186)
    • Europe – SCCS – Final Opinion on Kojic acid
    • Europe – Endocrine disruptors? SCCS closes comment period on phytoestrogens cosmetics safety
    • Europe – SCCS : Request for a scientific opinion on Salicylic acid
    • Europe – SCCS : OPINION on Prostaglandins and prostaglandin-analogues used in cosmetic products
    • Europe – EC Notifies WTO of Draft Amendment to Cosmetics Regulation to Prohibit Certain Nanomaterials
    • UK – Government to crack down on unregulated cosmetic procedures
    • Europe – Industry majors publish ‘practical and structured’ 10-step framework for animal-free safety analysis
    • Europe – SCCS : Request for a scientific opinion on Benzyl Salicylate
    • Europe – EDQM OCCL study reports low compliance of “kids’ cosmetics”
    • Europe – Recommandation (UE) 2021/2279 de la Commission Européen relative à l’utilisation de méthodes d’empreinte environnementale pour mesurer
    • Europe – Two cosmetics substances added to the Candidate List
    • Europe – Commission seeks views on revision of REACH, the EU’s chemicals legislation
    • Europe – Green Deal : la CE s’attaque à la déforestation importée. Quels impacts pour les ingrédients cosmétiques ?
    • Europe – Octocrylène : Sécurité confirmée de CE filtre UV
    • Europe – SCCS : REVISION of the scientific Opinion on Vitamin A 19
    • Europe – Tattoo inks and permanent make-up
    • Europe – SCCS/1638/21 Scientific Advice on the safety of Homosalate (CAS No 118-56-9, EC No 204-260-8) as a UV-filter in cosmetic products
    • UK – Post-Brexit chemical safety: SAG-CS process ‘not clarified’ and UK REACH having ‘massive impact’ on cosmetics
    • Europe – EC banning 20+ more hazardous chemicals in cosmetics
    • Europe – Décision (UE) 2021/1870 de la Commission du 22 octobre 2021 établissant les critères d’attribution du label écologique de l’UE aux produits cosmétiques et aux produits de soin pour animaux
    • Europe – Le maltol : vers la fin des nitrosamines dans les vernis à ongles ?
    • Europe – ‘Important milestone’: ECHA publishes advice on applying OECD non-animal skin sensitisation assessments under REACH
    • Europe – Guide on the classification and labelling of titanium dioxide
    • Europe – Cosmetics Europe chief: ‘Now is the time’ to ramp up EU dialogue on animal testing concerns
    • Europe – Le ton monte contre l’ECHA pour préserver l’interdiction des tests sur animaux
    • Europe – Cosmetics Regulation versus REACH: Study demonstrates EU in vivo testing regulation ‘conflict’
    • Europe – RAPPORT DE LA COMMISSION AU PARLEMENT EUROPÉEN ET AU CONSEIL sur l’utilisation de nanomatériaux dans les produits cosmétiques et la révision du règlement (CE) nº 1223/2009 relatif aux produits cosmétiques en ce qui concerne les nanomatériaux
    • Europe – EC official: Innovation for Chemicals Strategy for Sustainability to receive Horizon funding
    • Europe – EC official: No ‘major overhaul’ of Cosmetics Regulation planned under European Green Deal
    • Europe – Animal-free safety assessment New Science Programme to launch in 2022
    • Europe – Règlement (UE) 2021/850 de la Commission
  • Catégorie : International
    • Australia – TGA publishes updated guidelines for sunscreens
    • USA – « Global harmonization »: Review of regulation around the cosmetic world
    • Brazil – Consensus en faveur d’une interdiction fédérale des tests sur animaux
    • China – Safety and Technical Standard for Cosmetics 2022 (STSC 2022)
    • Asia – Safety overkill? How the rise of ‘coral safe’ sunscreen could hinder future formulations
    • USA – FDA calls on firms to be ‘recall ready’ in final guidance
    • USA – PFAS regulations are here, cosmetic companies need to prepare as legal barriers grow
    • New Zealand – NZ consumer watchdog calls for sunscreens to be regulated as therapeutic products
    • International – Etiquetage à l’international : Cosmed rappelle vos obligations
    • China – Des Lignes Directrices pour la Normalisation en Chine
    • Asia – The major cosmetics regulatory issues on the agenda for APAC in 2022
    • International – ECHA: Phtalates actualités
    • Australia – Mandatory regulations wanted: Lack of cosmetic legislation ‘devaluing’ Australian cosmetics industry
    • USA – Cosmetic Registration Reports (VCRP)
    • International – P&G discovers cancer-causing benzene in 18 consumer products
    • China – China’s regulations of children’s cosmetics will become ‘more stringent’
    • International – OECD non-animal skin sensitisation guideline a ‘landmark’ move
    • USA – Cosmetic Registration Reports (VCRP)
    • USA – FDA Releases Data from the Agency’s 2021 Testing of Talc-Containing Cosmetic Products for Asbestos
    • USA – FDA bans lead acetate from consumer hair dyes
    • USA – Cosmetic Registration Reports
    • USA – FDA unveils proposed changes to OTC sunscreen labeling, active ingredients
    • China – Chine : 11 réglementations au sein du Nouveau Cadre Réglementaire Cosmétique
    • Mexico – Mexican Senate gives final green light to ban animal testing for cosmetics
    • USA – Cosmetic Registration Reports (VCRP)
    • International – Notification of the 50th Amendment to the IFRA Standards
    • International – L’OCDE approuve les tests toxicologiques alternatifs de BASF et Givaudan
    • USA – Voluntary Cosmetic Registration Program Report (VCRP) for June 2021
    • China – CBD ban: Retailers ‘encouraged’ to pull products off shelves as regulators formally ban use in cosmetics
    • China – Retailers ‘encouraged’ to pull products off shelves as regulators formally ban use in cosmetics
    • International – Colgate-Palmolive files patent on ‘anti-irritant’ CBD antiperspirant
    • China – China cosmetics advertising: Shanghai association sets new standards that align with CSAR regulations
• Catégorie : Santé Publique
  • India – Indian labs to give ‘top priority’ to tests on cough syrup exports – regulator
  • France – Acidose lactique et metformine : un risque évitable
  • France – Congé menstruel : plusieurs propositions de lois déposées au Parlement sur le sujet
  • France – Covid-19 : les soignants non vaccinés peuvent officiellement réintégrer leur poste
  • France – Covid-19 : le gouvernement appelle les Français à « rester vigilants »
  • France – Covid-19 : les soignants non vaccinés pourront être réintégrés à partir de mi-mai
  • Europe – Statement from Emer Cooke on the end of the COVID-19 public health emergency
  • France – Covid-19 : le bras de fer inédit entre Agnès Buzyn et les juges de la Cour de justice de la République
  • France – L’Assemblée nationale adopte un texte supprimant l’obligation vaccinale des soignants contre le Covid-19
  • International – WHO announces launch of new pandemic preparedness initiative
  • France – Ségur numérique: les textes réglementaires de la vague 2 publiés en novembre
  • France – Lionel Collet est nommé président de la Haute Autorité de santé
  • France – Appareils de ventilation Philips : l’ANSM saisit la justice
  • International – Study unveils ‘breakthrough biomarker’ for Parkinson’s disease
  • UK – Crackdown on illegal sale of vapes
  • UK – Smokers urged to swap cigarettes for vapes in world first scheme
  • France – Publication du décret automatisant l’ouverture du dossier pharmaceutique
  • France – Les dossiers patients informatisés parmi les priorités de contrôle de la Cnil en 2023
  • USA – Johnson & Johnson offers $8.9bn to resolve all talcum powder lawsuits
  • USA – Texas federal judge halts FDA approval of abortion pill mifepristone; Biden administration filing appeal
  • International – Origine du Covid-19 : la présence de chiens viverrins sur le marché de Wuhan confirmée
  • France – Affaire des respirateurs Philips : l’agence du médicament saisit la justice
  • France – Papillomavirus : faut-il généraliser la vaccination ?
  • UK – Le gouvernement britannique va interdire le gaz hilarant
  • France – La médecine libérale sur le chemin d’un « règlement arbitral »
  • France – Congélation des ovocytes : un nouveau droit mais des délais très longs
  • France – Santé respiratoire France demande la prise en charge de la télésurveillance de l’oxygénothérapie
  • International – Apple voudrait faire de ses AirPods un dispositif médical
  • France – Des victimes des effets secondaires d’antibiotiques à base de fluoroquinolones portent plainte
  • USA – « Drogue du zombie » : les Etats-Unis prennent des mesures pour contrôler la circulation de la xylazine
  • USA – This Week at FDA: FDA draws roadmap for pandemic era guidances
  • USA – Stimwave Founder Arrested Over ‘Dummy’ Pain Implants
  • International – WHO countries begin negotiations on global pandemic preparedness agreement
  • Canada – Au Canada, des entreprises reçoivent l’autorisation de vendre de la cocaïne
  • France – L’utilisation de l’antidiabétique Ozempic pour maigrir inquiète les autorités de santé
  • France – Généralisation de la vaccination contre les infections à papillomavirus humains (HPV) en classe de 5e dès la rentrée 2023
  • France – Évolution de la prise en charge des tests de dépistage du Covid-19 à compter du 1er mars 2023
  • France – Papillomavirus : Emmanuel Macron annonce une campagne de vaccination généralisée dans les collèges
  • France – Un antibiotique et un vaccin efficaces pour prévenir les infections sexuellement transmissibles
  • France – L’antibiotique Josacine va disparaître des pharmacies
  • France – Covid-19 : la HAS publie sa recommandation de stratégie vaccinale pour 2023
  • France – L’expertise publique en santé en situation de crise – Rapport d’analyse prospective 2022
  • Europe – 3rd HIV patient virus-free after stem cell transplant
  • UK – First baby receives life-saving gene therapy on NHS
  • France – Protection des données de santé: le Cnom et la Cnil signent une convention de partenariat
  • France – Le Snof, la Cnam et l’ordre des médecins obtiennent le blocage d’un site internet proposant des ordonnances de correction de vue
  • France – La dotation pour 2023 du Health Data Hub fixée à 12,6 millions d’euros (arrêté)
  • International – World Health Organization releases new road map for breast cancer
  • France – Syndrome de CLOVES : 1ère mondiale à l’hôpital Necker
  • USA – FDA proposes easing blood donor requirements
  • France – Vague 2 du Ségur numérique: les exigences fixées en février, les textes réglementaires publiés en juin
  • France – « Depuis 2010, plus de 3 000 enfants de moins de 6 ans ont été hospitalisés pour intoxication au cannabis, plus de la moitié entre 2016 et 2019 »
  • Europe – EU outlines measures to mitigate antibiotic shortage across Europe
  • Europe – Europe’s Beating Cancer Plan: Launch of the European Cancer Imaging Initiative
  • International – WHO investigating links between cough syrup deaths, considers advice for parents
  • France – Inserm : la Cour des comptes appelle à une évolution radicale de l’institut de recherche
  • France – Fraude à l’Assurance-maladie : en Ile-de-France, deux centres de santé déconventionnés
  • France – Covid-19: vers une suppression du SI de traçage des cas contacts (projet de décret) SIH
  • International – World Health Organization releases latest set of COVID-19 guidelines
  • USA – Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics
  • USA – California sues largest US insulin manufacturers and PBMs for overpricing
  • France – Les naturopathes souhaitent une réglementation plus stricte de leur profession
  • France – Un naturopathe promoteur du jeûne mis en examen pour « homicide involontaire »
  • France – Covid-19: les chercheurs de SPF exposent les limites du système de surveillance déployé en France
  • France – Apnées du sommeil: niveau globalement élevé de l’observance des patients sous PPC télésuivis
  • France – Procès en appel du Mediator : on vous explique pourquoi l’affaire revient devant la justice
  • France – Une plateforme numérique pour faciliter la prise en charge des troubles neuropsychiatriques du Covid long
  • France – Macron se pose en sauveur du système de santé, sans avoir de « solution miracle »
  • International – WHO reports new Omicron subvariant cases detected in 29 countries worldwide
  • USA – Le coaching numérique réduit la consommation d’antipsychotiques chez des seniors atteints de démence
  • France – Médecins généralistes et téléconsultations: un recours bien plus fréquent chez les patients jeunes et peu précaires (Drees)
  • France – Une stratégie sur l’utilisation secondaire des données de santé en cours d’élaboration à la Drees
  • France – L’aggravation de l’épidémie de Covid-19 en Chine fait craindre des pénuries de médicaments en France
  • France – Avec une « triple épidémie » de Covid-19, bronchiolite et grippe, la « semaine de tous les dangers » pour le système de santé français
  • France – La loi de financement de la sécurité sociale pour 2023
  • France – Le Health Data Hub dévoile cinq nouveaux lauréats pour sa « bibliothèque ouverte d’algorithmes en santé »
  • International – Révélations sur la genèse d’un article majeur sur l’origine du SARS-CoV-2
  • France – Des applications pour contrôler la fertilité, vraiment ?
  • International – WHO warns bacteria drug resistance climbed in 2020
  • France – Bliss DTx: le pari réussi de la thérapie numérique par la preuve clinique
  • International – WHO publishes brief calling for integrated approach to epilepsy treatment
  • International – Produits du tabac chauffés pour le sevrage tabagique et la réduction de la prévalence du tabagisme
  • Europe – European commission: the first State of Health Preparedness Report
  • International – WHO member states commit to producing a pandemic accord in 2023
  • France – Face à la « triple épidémie », le ministre de la santé appelle à un « sursaut » de la vaccination
  • International – WHO report provides data for high levels of antimicrobial resistance in bacteria
  • France – Flash Sécurité Patient – « Téléconsultation : à distance, redoubler de vigilance »
  • UK – Pfizer/BioNTech COVID-19 vaccine authorised for use in infants and children aged 6 months to 4 years
  • France – Levothyrox : l’Agence nationale du médicament mise en examen pour « tromperie »
  • International – WHO calls for leaders to address the global HIV response
  • France – Condamnation de pirates informatiques six ans après la cyberattaque de l’ARS Ile-de-France
  • International – Covid-19 : les chiffres de l’épidémie en France et dans le monde, en cartes et en graphiques
  • USA – À 3,4 millions d’euros, le Hemgenix est le médicament le plus cher au monde
  • France – La HAS recommande la généralisation du dépistage de la drépanocytose à la naissance
  • France – Évènements indésirables graves associés à des soins (EIGS) : bilan annuel 2021
  • France – La Haute Autorité de santé recommande de vacciner tous les nourrissons contre les rotavirus.
  • France – La Cnam crée un département « télésanté et innovation numérique »
  • France – Assurance maladie complémentaire: la Cnil appelle à renforcer le cadre juridique pour l’utilisation des données de santé
  • France – Doctolib retirera les thérapeutes alternatifs de sa plateforme d’ici six mois
  • USA – FDA warns e-cig companies over products that look like toys and target children
  • France – Amazon Care est mort, vive Amazon Clinic!
  • USA – Maladie de Charcot : l’espoir d’un nouveau traitement
  • International – WHO: Global COVID-19 deaths down 90% since February
  • France – Un bel exemple
  • France – François Braun lance le catalogue Mon espace santé doté de ses 12 premières applications référencées
  • UK – Lab-grown red blood cells used for human transfusions in world-first clinical trial
  • France – Coup d’envoi de l’Agence de l’innovation en santé
  • France – Santé : les prescriptions d’antibiotiques aux enfants repartent à la hausse
  • France – Une télésurveillance de plus en plus basée sur les preuves (SFSD)
  • France – Variole du singe : malgré une baisse des cas, l’OMS estime qu’il reste des « raisons de s’inquiéter »
  • International – WHO publishes first-ever fungal priority pathogens list in face of antimicrobial resistance
  • USA – Covid long : les États-Unis vont tester l’efficacité du médicament Paxlovid
  • France – Doctolib va déréférencer les professions non réglementées, comme les naturopathes et les magnétiseurs, annonce son PDG
  • France – Bronchiolite : l’épidémie continue de progresser partout en France sur fond de crise de la pédiatrie
  • France – Budget de la « Sécu » : les laboratoires d’analyse menacent de cesser la transmission des données des tests de dépistage du Covid-19
  • France – CerHom : une association dont la vocation est de lutter contre les cancers masculins.
  • France – Covid-19 : les vérités d’Agnès Buzyn sur la gestion de la pandémie
  • France – Covid-19 : une huitième vague de d’« intensité modérée » en France, où « une croissance rapide du variant BQ.1.1 » a été détectée
  • France – Les laboratoires français assurent qu’il n’y a pas de pénurie de paracétamol
  • France – Levothyrox : chronologie de l’affaire, de la commercialisation de la nouvelle formule à la mise en examen de Merck
  • France – Retour sur le Sommet mondial de la Santé : « Faire le choix de la santé », à l’échelle mondiale et au-delà des crises
  • France – Implants contraceptifs Essure : une étude, non publiée par l’agence sanitaire, avait alerté sur les dangers
  • France – Levothyrox : la filiale française du laboratoire Merck annonce sa mise en examen pour « tromperie aggravée »
  • Europe – Prosecutor confirms probe into Europe’s COVID-19 vaccine purchasing
  • France – Coronavirus : identification de nouvelles protéines qui régulent l’infection
  • International – Le décret de la discorde
  • France – Une avancée majeure pour le système de santé : l’ensemble des ordres des professions de santé ont remis leur position commune aux ministres François Braun et Agnès Firmin Le Bodo pour répondre aux problématiques d’accès à la santé dans les territoires publié le13.10.22
  • France – PLFSS: les députés en faveur d’un renforcement du cadre d’interopérabilité et de sécurité des services numériques en santé
  • Haiti – Haiti risks new diseases amid cholera outbreak that has killed 18, says PAHO
  • International – Lebanon announces first death from cholera since detecting the disease in October
  • France – Cyberattaque: les enseignements tirés par le DSN et le chef de la pharmacie du CH de Villefranche-sur-Saône
  • USA- Heart surgeons want to do more xenotransplants
  • France – Encéphalite à tiques : remonter à l’origine des cas de transmission via le fromage
  • France – Budget de la Sécurité sociale : les concessions du gouvernement aux laboratoires pharmaceutiques
  • USA – New study finds brains of ‘superagers’ contain larger neurones in memory region
  • International – L’OMS alerte et ouvre une enquête sur des sirops contre la toux et le rhume après la mort de 66 enfants en Gambie
  • International – WHO unveils new initiative to halt spread of invasive malaria vector in Africa
  • France – La discrète arrivée de Sephora sur le marché de la parapharmacie
  • France – « La refondation du système de santé doit démarrer dès 2023 »
  • France – Don de sang: la France condamnée pour la collecte de données sur l’orientation sexuelle (CEDH)
  • International – WHO announces recommended 2023 flu vaccines for southern hemisphere
  • France – Recommandations concernant l’usage des produits de vapotage / cigarette électronique
  • France – Projet de loi de financement de la sécurité sociale (PLFSS) pour l’année 2023
  • USA – COVID-19 linked to long-term neurologic disorders in new US study
  • France – Budget de la « Sécu » 2023 : les comptes se redressent
  • Europe – EU health regulator says COVID pandemic not over
  • International – Pfizer to supply 6 million Paxlovid treatments to low- and middle-income countries
  • France – Le gouvernement rend gratuit l’accès à la pilule du lendemain pour toutes et le dépistage des IST
  • France – Prévention : des consultations médicales bientôt gratuites à 25, 45 et 65 ans
  • France – L’association Sauv Life déploie un dispositif paramédicalisé de téléconsultation à domicile
  • International – Sanofi remporte un succès dans un vaccin contre la bronchiolite
  • France – Fin de vie : l’ordre des médecins, opposé à l’euthanasie, réclame une « clause de conscience »
  • USA – FDA and NIHR launch public-private partnership for rare neurodegenerative diseases
  • International – Covid-19 : le tableau de bord de l’épidémie
  • France – Variole du singe : l’épidémie reflue grâce à la vaccination et à l’évolution des comportements
  • France – Justice : la directrice générale de Santé publique France relaxée
  • International – WHO calls for greater investment into research for millions living with long COVID
  • Brazil – Une mère de 19 ans donne naissance à des jumeaux ayant des pères biologiques différents
  • France – La justice face à la plainte en diffamation de Didier Raoult contre Karine Lacombe
  • France – Publication du décret relatif au traitement des données personnelles dans le cadre d’un don de gamètes
  • International – Machine-learning algorithm to non-invasively detect diabetes and pre-diabetes from electrocardiogram
  • France – Données personnelles: Doctolib défend la mise à jour de ses conditions d’utilisation
  • France – En pleine polémique, Doctolib suspend 17 profils liés à une naturopathe controversée
  • France – Le lancement de la carte Vitale biométrique inscrit au PLFR 2022
  • Europe – EMA response to the monkeypox public health emergency
  • France – Covid-19 : la « fin des régimes d’exception » en France actée avec l’adoption du projet de loi sanitaire
  • International – WHO advances plan for first malaria vaccine roll out in Africa
  • International – Monkeypox Symptoms Described in Large International Study
  • International – New diabetes reference guide focuses on helping pharmacists achieve required competencies
  • France – Les dispositifs portables de détection des crises d’épilepsie plus ou moins bien acceptés par les patients
  • International – La poliomyélite refait surface malgré les efforts pour l’éradiquer
  • International – Variole du singe : l’OMS déclenche son plus haut niveau d’alerte
  • France – Expérimentation: 1.774 téléconsultations d’ophtalmologie réalisées dans l’Aisne
  • France – Covid-19 : la HAS préconise le maintien de l’obligation vaccinale des personnels exerçant dans les établissements de santé et médico-sociaux
  • USA – Un cas de polio détecté aux Etats-Unis pour la première fois depuis 2013
  • France – Le projet de loi sanitaire, et la fin des régimes d’exception pour lutter contre l’épidémie de Covid-19, approuvés par le Sénat
  • UK – Over 285,000 medicines and medical devices seized UK-wide in global action
  • France – Vaccin contre le Covid-19 : les femmes qui subissent des troubles menstruels sont invitées à les déclarer
  • Europe – Europe must act now or risk tougher COVID measures later, WHO official says
  • France – Le « tout numérique » accroît les inégalités d’accès aux soins
  • France – La CNIL adopte un référentiel sur la gestion des officines de pharmacie
  • Canada – Health Canada authorizes use of Moderna COVID-19 vaccine in children 6 months to 5 years of age
  • International – Researchers create ‘world’s largest’ database for predicting cancer treatment response
  • France – Monkeypox : Mise en œuvre de la vaccination et n° d’information
  • France – Ce que l’on sait des réinfections au Covid-19 : sont-elles plus fréquentes, quelles personnes sont majoritairement concernées ?
  • France – Le projet de loi sanitaire provoque des débats électriques à l’Assemblée nationale
  • France – HAS : Monkeypox : une vaccination préventive proposée aux personnes les plus à risque d’exposition
  • Switzerland – New Swiss research reveals how Omicron evades the immune system
  • USA – FDA allows pharmacists to prescribe Pfizer’s COVID-19 pill
  • France – Lucile Blaise élue présidente du Snitem
  • France – Variole du singe : l’OMS appelle à une action « urgente » en Europe compte tenu de la flambée des cas
  • Europe – Les évaluations du cannabidiol en tant que nouvel aliment sont suspendues dans l’attente de nouvelles données
  • Europe – La Commission européenne propose d’interdire les versions aromatisées de tabac chauffé
  • France – Covid-19 : les consignes de prudence minimales du gouvernement
  • USA – Intérêt de la thérapie cognitivo-comportementale numérique pour améliorer l’insomnie et réduire une prise de cannabis associée
  • International – Enanta takes legal action against Pfizer over Paxlovid patent infringement
  • France – Variole du singe : 330 cas confirmés en France, l’OMS appelle l’ensemble des pays à la transparence
  • France – La HAS lance QualiScope : le service en ligne qui permet à tous de s’informer sur le niveau de qualité des hôpitaux & cliniques
  • France – « Data Pathologies »: l’assurance maladie lance un site sur les dépenses de santé
  • France – Comment les données de vie réelle accélèrent la recherche sur les maladies rares
  • Europe – Research from Imperial College London shows single brain scan could diagnose Alzheimer’s disease
  • UK – Blood vessel breakthrough is major step towards Alzheimer’s treatment
  • International – WHO to convene emergency committee on monkeypox
  • France – Attention aux appels et courriels frauduleux usurpant le nom de l’ANSM
  • Europe – EU governments pressure manufacturers to renegotiate contracts for COVID-19 vaccines
  • Europe – COVID-19: Council and European Parliament reach a provisional political agreement to extend the regulation establishing the EU digital COVID certificate
  • International – Variole du singe : comment se transmet-elle, quels sont les symptômes ?
  • France – Covid-19 : le tableau de bord de l’épidémie
  • France – Santé : tout un système à revoir
  • France – Le HCSP prône des évolutions du carnet de santé de l’enfant en vue de son passage au numérique
  • France – La DNS publie des recommandations pour une « conception éthique » de l’IA
  • France – Variole du singe : l’infectiologue Karine Lacombe se dit « plutôt inquiète »
  • USA – Cancer colorectal: la détection d’adénomes par coloscopie améliorée par une IA
  • Africa – Variole du singe : les pays africains réclament un accès équitable au vaccin
  • India – Serum Institute of India considering expansion into Africa
  • France – Risques neurologiques et psychiatriques des formes longues de Covid-19
  • Mexico – La cigarette électronique interdite au Mexique
  • Israël – L’intelligence artificielle pourrait raccourcir le diagnostic du rhumatisme psoriasique
  • France – Vers une épidémie mondiale de variole du singe ? Martin Blachier brise le silence !
  • Europe – First The UK, Now France: Is Needle-Spiking Spreading In European Clubs?
  • France – HAS : Monkeypox : vacciner les adultes et professionnels de santé après une exposition à la maladie
  • USA – FDA takes steps to relax blood donor requirements
  • France – Variole du singe : un premier cas d’infection confirmé en France
  • France – Premières expérimentations du congé menstruel en France : un bilan mitigé
  • International – Monkeypox confirmed in the U.S. and Europe
  • France – Dépakine : Sanofi condamné à indemniser une famille dont la fille est née avec des malformations
  • USA – Some patients reporting COVID rebounds after taking Pfizer pills
  • International – WHO calls on Pfizer to make its COVID pill more available
  • International – WHO releases estimates of 14.9 million excess deaths during COVID-19 pandemic
  • Europe – Covid-19 : pourquoi l’Agence de sécurité du médicament retire du marché le spray nasal Previdspray ?
  • Europe – Commission proposes European Health Data Space to unlock research opportunities
  • France – Médecins: la liste des documents à verser obligatoirement au DMP fixée par arrêté
  • USA – Hépatites inexpliquées : les Etats-Unis lancent une enquête sur la mort de cinq enfants
  • UK – New long COVID study highlights key symptoms
  • Europe – COVID-19 – Sustaining EU Preparedness and Response: Looking ahead
  • France – Tralelho, traducteur médical gratuit aux ambitions internationales
  • Europe – Des cas d’une hépatite infantile d’origine inconnue détectés dans cinq pays d’Europe
  • USA – « Aux Etats-Unis, les Noirs continuent à mourir cinq ans plus tôt que les Blancs »
  • UK – Cannabis firm launches UK clinic following prescription license allocation
  • International – WHO: 1 dose of HPV vaccine effective for cervical cancer
  • International – Novel process converts skin cells to look 30 years younger
  • France – Symptômes prolongés à la suite d’une Covid-19 de l’enfant et de l’adolescent
  • France – Iatrogénie médicamenteuse: Synapse Medicine lance « Goodmed », son application grand public
  • International – WHO monitoring new Omicron subvariant XE
  • France- Le démarrage raté du Paxlovid, la pilule anti-Covid de Pfizer
  • International – Antibodies recognize new SARS-CoV-2 Omicron variant after booster
  • USA – Les soins virtuels, l’imagerie avancée et la voix, grandes tendances du congrès HIMSS
  • France – Une flambée de grippe accompagne la fin du port du masque obligatoire
  • International – Pandémie de Covid-19 : le grand gaspillage des vaccins
  • France – Cigarette électronique : « Les données actuellement disponibles ne permettent pas d’évaluer le risque potentiellement associé à son utilisation »
  • France – Le SARS-CoV-2 peut provoquer une inflammation du fœtus
  • France – Le COVID-19 augmente le risque de diabète de type 2
  • France – Produits de vapotage / cigarette électronique
  • International – Scientists identify two more hybrid variants alongside Deltacron
  • UK – Omicron BA.2 variant triggers COVID-19 surge in England
  • France – Levothyrox : la Cour de cassation rejette le pourvoi de Merck, condamné à indemniser les plaignants
  • France – Le ministère des solidarités et de la santé et l’Agence de la biomédecine dévoilent un nouveau plan d’action ministériel ambitieux et innovant pour le prélèvement et la greffe d’organes et de tissus pour la période 2022-2026
  • USA – Vaping alters mouth microbes
  • France – Lyme : la HAS publie un guide de parcours de soins structuré en cas de suspicion de la maladie
  • UK – COVID-19 infections seeing spike across UK
  • Europe – CIVID : Un variant Delta-Omicron recombinant détecté en France
  • USA – Mandatory masking in schools reduced COVID-19 cases during Delta surge
  • France – Scandale de la Dépakine : « Arrêtons de donner ce médicament aux femmes enceintes »
  • UK – UK COVID-19 cases rising among those aged 55 and older
  • USA – Malgré le décès du patient, la première xénogreffe avec un cœur porcin est considérée comme un succès
  • France – Télémédecine: le Cnom s’inquiète d’un « mésusage » et cible les plateformes
  • France – Conciliation médicamenteuse: Synapse Medicine lève 25 millions d’euros
  • France – En établissement, l’élaboration de certificats de décès se fera obligatoirement par voie électronique (décret)
  • International – Moderna dévoile son plan pour prévenir les futures pandémies
  • France – Fin du masque et du passe vaccinal : la France parie sur la suppression presque complète des restrictions sanitaires
  • France – « Sur la cigarette électronique, le Haut Conseil de la santé publique a une position “antivape” avec des arguments “antivax” »
  • UK – Outbreaks of norovirus increasing in England
  • France – TousAntiCovid: une utilité « marginale » et des fonctionnalités de traçage largement sous-utilisées
  • USA – Digital smoking treatment device gets breakthrough status
  • France – « Oui au masque », l’appel de certains Français à garder son masque en intérieur
  • France – Cybersécurité: la Cnil clôt la mise en demeure de la société Francetest
  • UK – PANORAMIC view of World’s largest COVID study
  • UK – England to end COVID-19 isolation laws and mass free testing
  • UK – COVID-19 booster to be made available to those over 75 and high risk adults and children
  • International – WHO chief stresses importance of global vaccination goals
  • USA – Senate confirms Califf as FDA commissioner
  • International – COVID-19 vaccines induce immune response to Omicron
  • International – Covid-19 : les cas de syndrome inflammatoire infantile augmentent, mais semblent moins sévères
  • France – Covid-19: la Cnam lance un nouveau service pour lister les cas contacts
  • USA – CDC updates booster guidance for immunocompromised
  • France – Du DMP à « Mon espace santé »: retour sur deux décennies de construction du « carnet de santé numérique »
  • France – Données de santé: Interhop saisit la Cnil sur l’utilisation de Google Analytics par des acteurs de santé
  • Europe – Covid-19 : des pédiatres s’inquiètent des nouveaux symptômes provoqués par Omicron chez les enfants
  • France – Le ministère lance un « tour de France » de la stratégie d’accélération du numérique en santé
  • France – Pour Martin Hirsch, la vulnérabilité des systèmes d’information est un « risque majeur »
  • International – Don’t underestimate Omicron subvariant, WHO says
  • International – New Omicron subvariant appears more transmissible but no more severe than original Omicron strain
  • France – Restrictions sanitaires: ce qui change à partir de ce mercredi
  • France – « Vapoter est une aide précieuse, voire déterminante, pour quitter le tabac »
  • UK – England returns to Plan A as regulations on face coverings and COVID Passes change today
  • France – Covid-19 : une forte augmentation des syndromes inflammatoires chez les enfants
  • France – Covid-19 : la « différence  » entre les poumons des vaccinés et des non-vaccinés
  • France – La loi créant une plateforme de référencement des Covid longs définitivement adoptée
  • France – Bercy annonce une stratégie dotée de 2,3 milliards d’euros pour accompagner les « start-up industrielles et deep tech »
  • International – Omicron : la moitié de l’humanité contaminée d’ici la fin du mois de mars ?
  • France – Covid-19 : « Le port d’un masque FFP2 peut donner un faux sentiment de sécurité »
  • UK – England to return to Plan A following the success of the booster programme
  • France – Face au variant Omicron, faut-il généraliser le port du masque FFP2 ?
  • Europe – RD-Code: Final results of EU project to promote coding with ORPHAcodes
  • France – Covid-19 : ce que l’on sait du Paxlovid, le traitement de Pfizer qui sera disponible en France fin janvier
  • France – Covid-19 : un soupçon d’espoir dans les chiffres de l’épidémie
  • UK – UKHSA estimates one in seven still infectious after five day COVID-19 isolation
  • France – Création du système d’information du numéro national de prévention du suicide (décret)
  • France – Psychiatrie: déjà 8.500 visites sur l’outil en ligne d’aide au diagnostic Psychiaclic pour les généralistes
  • France – Passe vaccinale : la date et les modalités de fin de la mesure opposent le Sénat et le gouvernement
  • Europe – Omicron va faire sortir le Covid-19 de la phase pandémique, estime l’Agence européenne des médicaments
  • USA – Un patient en phase terminale se fait greffer un cœur de porc, une première mondiale
  • France – Covid-19: augmentation de la capacité quotidienne de tests pour faire face à la surcharge de Sidep
  • France – Le Sénat repousse en commission la création d’une plateforme de référencement des Covid longs
  • International – Mesure de constantes par caméra, maintien à domicile et chirurgie augmentée: les grandes tendances françaises au CES 2022
  • UK – PCR not needed following lateral flow test under new guidelines
  • France – Bientôt de nouvelles techniques pour « voir » l’arthrose ?
  • International – Vaccin contre le Covid: Israël suspend la quatrième dose
  • France – Martin Blachier : « La vague Omicron est un phénomène fabriqué »
  • France – Un décret modifie les systèmes d’information Sidep et Vaccin Covid
  • France – Les députés prolongent la prise en charge intégrale de la téléconsultation jusqu’à la mi-2022
  • International – Moins d’hospitalisations et de décès pour Covid-19 après vaccin à ARN m, CQFD (encore)
  • France – Dangerosité, impact vaccinal… Les scénarios de l’Institut Pasteur sur la vague Omicron
  • France – Cyberattaques d’Ehpad ou d’établissement de santé: « Le vrai danger, c’est la modification des données de santé »
  • France – Covid-19 la HAS préconise de réduire à 3 mois le délai pour le rappel
  • Ecuador – L’Equateur rend la vaccination contre le Covid obligatoire dès l’âge de 5 ans
  • France – Covid-19: à l’AP-HM, «86% des patients en réanimation ne sont pas vaccinés ou ont reçu une seule dose»
  • Australia – The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2
  • USA – Fauci says a redefinition of fully vaccinated is ‘on the table’
  • France – Covid-19 : « La vague Delta va être suivie de la vague Omicron », prévient Alain Fischer
  • USA – Le docteur Fauci prévient que le variant Omicron «se déchaîne» à travers le monde
  • France – COVID -19 : La HAS favorable à l’ouverture de la vaccination sans obligation aux enfants de 5 à 11 ans
  • France – Rhume : certains médicaments peuvent provoquer des effets indésirables graves selon les autorités sanitaires
  • France – Selon Martin Blachier, « le comité scientifique est composé de gens qui n’ont pas le niveau et font des analyses médiocres »
  • USA – FDA says abortion pills can be sent by mail
  • International – Vaccines still provide ‘significant protection’ against severe COVID-19
  • UK – South Africa releases first real-world evidence for Omicron
  • France – Covid-19. Faut-il s’attendre à un raz-de-marée, en janvier, avec le variant Omicron ?
  • France – « Sans masque, sans fermeture, sans protocole ! » : Martin Blachier réclame une « rentrée normale » pour les enfants
  • France – Interventions visant à prévenir la prise de poids après un sevrage tabagique
  • International – Pfizer Says Covid-19 Pill Is 89% Effective in Preliminary Assessment
  • France – Covid-19: l’application TousAntiCovid prolongée jusqu’au 31 juillet 2022 (décret)
  • France – Variant Omicron: vers une sixième vague de Covid-19 en janvier?
  • France – Covid-19 : il est désormais possible de se faire vacciner le dimanche en pharmacie
  • France – « Talents de la e-santé 2022 »: la DNS et l’ANS récompensent 11 projets dans de nombreux domaines
  • UK – Health minister welcomes new treatments for COVID-19 patients
  • France – La Dépakine aurait des effets toxiques sur plusieurs générations, selon une association
  • International – WHO says vaccines should be effective against Omicron variant
  • France – Un établissement psychiatrique déclassé en Haute Marne
  • UK – UK marks one year since deploying world’s first COVID-19 vaccine
  • UK – UK study shows mixing Pfizer and AstraZeneca COVID-19 vaccines with Moderna elicits better immune response
  • France – Vaccination Covid-19: la Cnam ouvre un téléservice pour calculer la date de rappel
  • Africa – Africa faces challenges to COVID-19 vaccine campaigns
  • France – Future4Care recrute 22 start-up pour sa première promotion
  • France – La vaccination des 5-11 ans pourrait débuter en janvier
  • Europe – Next virus could be more lethal than COVID-19, warns Oxford vaccine creator
  • France – Vaccination Covid-19: Covidliste rouvre sa plateforme
  • France – Les députés approuvent la création d’une plateforme de référencement des Covid longs
  • UK – Unvaccinated mothers urge pregnant women to get jabbed
  • France – La Cnil redemande au gouvernement d’évaluer l’efficacité des systèmes d’information de lutte contre le Covid-19
  • International – Annual COVID-19 jabs likely, says Pfizer head
  • International – Possible identification of blood clot trigger for AstraZeneca COVID-19 vaccine
  • France – Covid-19 : diagnostic et prise en charge de PIMS de l’enfant
  • France – Le CHU de Rennes est passé en 2 ans du microscope à une pathologie 100% numérique
  • Europe – Variant Omicron : l’Agence européenne des médicaments pourrait approuver des vaccins d’ici 4 mois
  • UK – Scotland expands vaccine rollout in the face of rising Omicron cases
  • UK – GSK aim for HIV cure by 2030
  • France – Covid-19 : la HAS recommande la vaccination des enfants fragiles
  • France – Covid-19: la première modélisation d’Omicron montre bien plus de mutations que sur le variant Delta
  • International – OMICRON : le nouveau variant B.1.1.529 du Covid-19 classé « préoccupant » par l’OMS
  • International – BioNTech starts work on Omicron-specific vaccine
  • UK – Government takes decisive action against new COVID-19 variant
  • UK – Britain alarmed by new COVID-19 variant spreading in South Africa
  • USA – Pfizer Sues Departing Employee It Says Stole COVID-19 Vaccine Secrets
  • France – La HAS se dote d’une cellule sur les données en vie réelle
  • France – Faut-il vacciner les enfants contre la Covid-19 ?
  • USA – Le Covid-19 accroît le risque d’enfant mort-né, selon une étude américaine
  • UK – Under-18s with COVID-19 in UK advised to wait 12 weeks for vaccine dose
  • USA – Lung autopsies of COVID-19 patients reveal treatment clues
  • France – Vaccination anti-Covid: la liste des patients éligibles à la dose de rappel désormais accessible aux médecins traitants (Cnam)
  • France – « Le masque ne disparaîtra plus de notre mode de vie » : Karine Lacombe fait une confidence étonnante
  • International – COVID-19 : augmentation des infections, vaccin obligatoire pour les enfants au Costa Rica, restrictions pour les non-vaccinés…
  • International – Pfizer signs deal to allow expanded use of COVID-19 treatment
  • USA – Le PDG de Johnson & Johnson intègre le conseil d’administration d’Apple
  • France – Le risque de myocardite et péricardite après la vaccination Covid-19 est confirmé mais peu fréquent et d’évolution favorable
  • USA – Biden nominates Califf as FDA commissioner
  • USA – Real-world evidence from EHR supports antimicrobial resistance fight
  • France – LEEM : COVID-19 et vaccins : Questions-réponses
  • France – HAS : Vaccination dans le cadre de la Covid-19
  • France – Covid-19 : la dose de rappel élargie aux 50-64 ans à partir de début décembre
  • USA – The Pfizer/BioNTech COVID-19 vaccine has been approved for children ages 5 to 11
  • International – Pfizer says its antiviral pill slashes risk of severe COVID-19 by 89%
  • France – Téléconsultation en pharmacies: Livi s’allie à well&well
  • France – « Le virus est inarrêtable »: pour l’infectiologue Éric Caumes, la stratégie Zéro Covid est « irréaliste »
  • France – Un système de « biopsie virtuelle » pour la transplantation rénale
  • France – Sécurité informatique: les chantiers du ministère de la santé en 2022 (FSSI)
  • USA – Vaccination more protective than history of COVID-19
  • International – Des cancers cutanés rares et agressifs mal évalués par une application mobile grand public
  • USA – NIH to study long-term effects of COVID-19 in pregnancy
  • UK – E-cigarettes could be prescribed on the NHS in world first
  • France – Les créateurs de startups de la e-santé interrogés sur leurs difficultés
  • France – Isolement et contention en psychiatrie: bientôt un référentiel pour les éditeurs de logiciels
  • France – COVID-19 : un virus plus contagieux et plus mortel dans le futur ?
  • UK – Double vaccinated can still spread COVID-19 at home, says UK study
  • France – Les premiers traitements anti-Covid arrivent, la France en commande 50 000 doses
  • Brazil – « La nouvelle Chloroquine » fait plusieurs morts au Brésil
  • USA – Autoimmune response found in many with COVID-19
  • France – Le volet autonomie du PLFSS étudié en 1ère lecture à l’Assemblée nationale : la réforme s’accélère
  • France – COVID-19 en France: l’efficacité des vaccins est confirmée par les données en vie réelle
  • France – Ségur numérique: la DGOS encourage les hôpitaux à se saisir du programme SUN-ES
  • France – Bourgogne-Franche-Comté: plus de 30.000 dossiers patients ouverts sur la plateforme de coordination eTICSS
  • France – TousAntiCovid: près de la moitié des utilisateurs activent la fonctionnalité de traçage en permanence-
  • Europe – Diabète de type 1: des données de vie réelle favorables au système de boucle fermée Diabeloop
  • USA – FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency
  • France – HTA : la HAS actrice de la coopération européenne pour l’évaluation des technologies de santé
  • France – Portabilité des données de santé: les médecins de ville pris entre flou juridique et casse-tête technique
  • France – Convention médicale: les mesures numériques et informatiques de l’avenant n°9
  • France – Filières de santé maladies rares
  • France – Application Orphanet Guides: Nouvelle version disponible
  • France – Covid-19 : la HAS élargit le périmètre de la dose de rappel
  • International – Historique : Le premier vaccin antipaludique pour les enfants vivant dans les zones à risque
  • International – Use of artificial intelligence for image analysis in breast cancer screening programmes: systematic review of test accuracy
  • France – La cyberattaque du CHU de Rouen, « un électrochoc » pour les directeurs généraux de CHU
  • France – Covid-19 : l’Agence européenne du médicament approuve l’utilisation d’une dose de rappel du vaccin Pfizer pour l’ensemble des plus de 18 ans
  • France – Covid : Sanofi renonce à son vaccin à ARN messager
  • France – Tabac : le marché parallèle de cigarettes fait perdre « 3 milliards de recettes fiscales » à la France
  • UK – Une musicienne joue du violon pendant l’opération de son cerveau
  • France – Remboursement du psy sur prescription dès 3 ans
  • USA – Should the US government share the Moderna COVID vaccine recipe?
  • France – Covid-19 et grippe : la HAS précise les conditions d’une co-administration des vaccins
  • France – SARS-CoV‑2 : La muqueuse nasale arbore des mécanismes de défense spécifiques
  • France – Le Projet de loi de financement de la sécurité sociale (PLFSS) pour l’année 2022
  • France – Fuite du passe sanitaire d’Emmanuel Macron: la Cnam saisit les ordres professionnels
  • France – 1000 premiers jours des enfants : une nouvelle application du ministère de la Santé
  • France – Opération Lindberg : première téléchirurgie à des milliers de kilomètres
  • France – L’AP-HP notifie la cyberattaque aux patients et professionnels touchés par le vol de données
  • France – Cyberattaque: l’AP-HP porte plainte après le vol des données de plus d’un million de personnes
  • International – Coronavirus : chiffres clés et évolution de la COVID-19 en France et dans le Monde
  • France – Grâce à la vaccination, l’épidémie de Covid-19 continue sa décrue rapide en France
  • France – La FEMTECH, parent pauvre de l’e-santé
  • France – HAS: Dominique Polton nommée vice-présidente de la Ceesp
  • France – Le ministère des solidarités et de la santé lance une campagne de promotion de l’e-santé
  • UK – JCVI does not recommend COVID-19 vaccination for all 12 to 15-year-olds
  • France – Lévothyrox : une nouvelle action collective lancée contre l’Agence nationale de sécurité du médicament
  • International – L’OMS publie un nouveau répertoire des technologies sanitaires innovantes pour la COVID-19 et d’autres maladies prioritaires
  • France – Le dossier de vaccination du président MACRON : Une nouvelle affaire ?
  • USA – Fauci: 3-dose COVID-19 vaccine may become routine
  • USA – FDA convenes adcomm for Pfizer COVID booster
  • International – UK and Australia agree to share vaccines to tackle global pandemic
  • USA – FDA’s director and deputy director of its Office of Vaccines Research & Review resign
  • France – Covid-19 : où en est la recherche de traitements contre la maladie ?
  • France – Déficits rares en protéines de la coagulation
  • International – Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting
  • Israel – Israel’s COVID-19 vaccine boosters show signs of taming Delta
  • UK – Study finds protection against COVID-19 ‘waning’ in fully vaccinated people
  • France – Passe sanitaire: vers une autorisation des certificats de preuve internationaux en France (décret)
  • France – Vaccination contre la Covid en France : au 25 août 2021, près de 85 732 000 injections ont été réalisées
  • France – Le ministère des Solidarités et de la Santé et Skyrock annoncent la tournée du Vaxibus « Ça va ? Ça vax ! »
  • France – Covid-19 : la HAS précise les populations éligibles à une dose de rappel de vaccin
  • Europe – Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
  • France – IVG: la télémédecine est une solution pour de nombreuses femmes en France, au-delà du confinement
  • France – Publication du décret permettant la mise en oeuvre de l’espace numérique de santé (ENS)
  • France – Le CH d’Arles touché par une cyberattaque
  • UK- Price hike for Pfizer/BioNTech COVID-19 vaccine as UK orders boosters for 2022
  • France – Fichage sur le glyphosate: la Cnil inflige à Monsanto une amende de 400.000 euros
  • International – Aux États-Unis, l’animateur radio qui refusait de se faire vacciner est finalement mort du Covid-19
  • France – L’ARN messager : une arme vaccinale sûre et très efficace contre la Covid-19
  • France – Covid-19 : un décret fixe la liste des contre-indications à la vaccination, permettant d’être exempté de pass sanitaire
  • France – Le Dr Jérôme Marty porte plainte contre Nicolas Dupont-Aignan pour propos diffamatoires
  • France – Création du comité stratégique des données de santé
  • France – Passe sanitaire: les biologistes autorisés à verser les résultats de tests RT-PCR positifs de plus de 3 mois dans Sidep
  • UK – Long COVID rare in children, KCL study finds
  • Europe – New European supply deals show Pfizer and Moderna have increased COVID-19 vaccine prices
  • France – Covid-19 : quelle protéine virale les TROD doivent-ils cibler en sérologie pré-vaccinale ?
  • France – L’université Côte d’Azur de Nice crée un DU « intelligence artificielle et santé »
  • France – Covid-19 : le vaccin Spikevax® de Moderna peut être utilisé à partir de l’âge de 12 ans
  • France – Une pharmacienne arrêtée dans le cadre d’un trafic de certificats de vaccination en région parisienne
  • France – Données de santé des officines: l’Autorité de la concurrence annonce des « opérations de visite et saisie » dans trois entreprises
  • France – Covid-19 : quelle viabilité du virus SARS-CoV-2 dans l’air ?
  • France – « Article 51 »: un arrêté prolonge et élargit l’expérimentation relative à la télésurveillance du diabète gestationnel
  • International – Covid-19 : parfois, des symptômes persistent pendant plusieurs mois
  • France – Covid-19 : l’Agence du médicament mène des investigations sur d’éventuels « manquements » lors d’essais cliniques à l’IHU de Marseille
  • France – Covid-19: la France est officiellement entrée dans la quatrième vague
  • UK – New advice issued on COVID-19 vaccination of children and young people
  • France – Le port du masque ne sera plus obligatoire dans les lieux concernés par le pass sanitaire
  • USA – FDA reports rare complications with Pfizer COVID vaccine, updates J&J safety info
  • France – Covid-19 : les non-vaccinés représentent 80% des cas positifs
  • France – « Luna »: l’application d’aide au diagnostic de l’endométriose prépare sa sortie
  • International – Study: Flu vaccine may lower severe COVID-19 risk
  • USA – Moderna to study COVID-19 vaccine in pregnant women
  • International – FDA lists rare neurological condition as potential side effect of J&J’s COVID-19 vaccine
  • International – World Mask Week campaigners encourage continued mask wearing to help slow the spread of COVID-19
  • France – Cybersécurité: le réseau Cerba victime d’une fuite de données (presse)
  • France – Covid-19 : repérer et déclencher la prise en charge du syndrome inflammatoire multi-systémique (PIMS) de l’enfant
  • France – Avis n° 2021.0042/AC/SEAP du 17 juin 2021 du collège de la HAS relatif aux modifications des conditions d’inscription sur la LAP mentionnée à l’article L. 162-1-7 du CSS, de la détection des anticorps sériques dirigés contre le coronavirus SARS-CoV-2
  • France – Covid-19: plus d’un million de rendez-vous pour la vaccination pris sur Doctolib depuis les annonces d’Emmanuel Macron
  • France – Concert-test d’Indochine : pas de “sur-risque” de propagation de Covid-19, selon l’AP-HP
  • France – Levées de fonds dans l’e-santé: le record de 2020 déjà battu en 2021
  • France – Covid-19 : adapter la stratégie de vaccination pour faire face au variant delta
  • France – Covid-19 : la HAS précise ses recommandations sur l’utilisation du vaccin Janssen chez les moins de 55 ans
  • France – Vaccins contre le Covid-19 : Pfizer-BioNTech va demander l’autorisation à l’Agence européenne des médicaments pour une troisième dose
  • International – Israel study suggests Pfizer/BioNTech vaccine is less effective against Delta variant
  • France – Sécurité informatique: le ministère de la santé relance la campagne de sensibilisation et d’information « tous cybervigilants »
  • UK – MHRA outlines two-year delivery plan with ‘patient first’ focus
  • International – Covid-19. Que sait-on des nouveaux variants Epsilon et Lambda ?
  • France – Pluie d’hommages après la mort du généticien Axel Kahn
  • France – Health Data Hub: la Cnil émet plusieurs réserves sur la nouvelle organisation du système national des données de santé
  • France – Covid-19 et odorat : les anosmies persistantes sont fréquentes et impactent la qualité de vie
  • France – Plus de 8 Français sur 10 favorables au développement du numérique en santé (sondage Harris)
  • France – Vaccination : attendre est une « erreur », estime Alain Fischer
  • USA – Delta variant now accounts for 26.1% of US COVID-19 cases
  • Europe – L’UE demande aux plateformes de surveiller davantage la désinformation en ligne sur le Covid-19
  • International – J&J’s COVID-19 vaccine shows ‘strong’ activity against Delta variant
  • UK – COVID-19 booster dose programme planned for September launch in Britain
  • France – Covid-19 : deux doses de vaccin immuniseraient contre le variant Delta selon l’Agence européenne du médicament
  • France – La France va recommencer à produire du paracétamol dès 2023
  • France – Delfraissy, Pialoux… De plus en plus de voix pour la vaccination obligatoire des soignants
  • France – Covid-19 : «Ce virus ne va jamais disparaître», prévient le Pr Pittet
  • France – Anticancéreux périmé : procès de deux dirigeants de laboratoires
  • International – Changing Landscape: The Role of Patient Influencers in the Healthcare Ecosystem
  • France – Données de santé: si c’est gratuit, c’est vous le produit!
  • Europe – Le Conseil de l’Europe nomme la future Directrice de l’EDQM
  • France – Le microbiote influencerait la réponse vaccinale
  • France – Avis n° 2021.0042/AC/SEAP du 17 juin 2021 du collège de la HAS relatif aux modifications des conditions d’inscription sur la LAP mentionnée à l’article L. 162-1-7 du CSS, de la détection des anticorps sériques dirigés contre le coronavirus SARS-CoV-2
  • USA – Include cancer patients in COVID-19 vaccine trials, say ASCO and Friends of Cancer Research
  • France – Numérique en santé mentale: « un facteur d’émancipation » pour les patients (Frank Bellivier)
  • France – Ce que prévoit le plan de renforcement de la sécurité informatique en santé
  • France – Sanofi démarre des essais sur l’homme pour un vaccin à ARN messager contre la grippe
  • International – La santé humaine sous la menace du réchauffement climatique
  • UK – Le Premier Ministre Britannique privilégie la « Santé Publique » à la finale à Wembley
  • France – Bioproduction: un « campus biotech digital » de formation ouvert « dès la rentrée »
  • France – Covid-19 : face aux variants émergents, vacciner de manière réactive
  • France – Covid-19: la Cnam déploie progressivement le « rétro-tracing » et prépare sa généralisation au 1er juillet
  • Switzerland – Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update
  • France – Les modifications du référentiel « Identifiant national de santé » approuvées par arrêté
  • Europe – Court rules on AZ and EU’s COVID-19 vaccine dispute
  • France – Levothyrox : l’ancienne formule du médicament sera disponible au moins jusqu’à fin 2022
  • France – L’Agence du médicament retient un « rôle possible » du vaccin Pfizer dans les cas de myocardite
  • France – Covid-19: le CCL-Covid demande un meilleur suivi des infections nosocomiales, des déprogrammations et des parcours patients
  • France – Il ne sera plus possible d’ouvrir un DMP à partir du 1er juillet (Cnam)
  • France – Données en santé et social : savoir les exploiter pour mieux suivre les pratiques
  • France – Tiers payant en établissement de santé: signature d’un accord national pour le déploiement du dispositif ROC
  • USA – FDA panel split on approach to COVID-19 vaccines for younger children
  • France – Covid-19: les modalités de mise en oeuvre du passe sanitaire détaillées par décret
  • UK – Données de santé: Londres joue la montre
  • France – Nouvelles nominations à la HAS
  • France – Covid-19: deux niveaux d’alerte différents dans la fonctionnalité « signal » de TousAntiCovid
  • France – Un décret acte la prise en charge du télésoin pour les auxiliaires médicaux et les pharmaciens et élargit la sollicitation de la télé-expertise
  • France – Stratégie de vaccination contre la Covid-19 – Place du vaccin à ARNm COMIRNATY® chez les 12-15 ans
  • France – Covid-19 : maintien de l’intervalle entre deux doses du vaccin AstraZeneca face à l’émergence du variant indien
  • France – Covid-19 : des TROD pour optimiser l’utilisation des doses de vaccins disponibles
  • France – Covid-19 : la vaccination des adolescents présente des bénéfices individuels et collectifs
  • France – « Article 51 »: l’expérimentation « télésurveillance du diabète gestationnel » vers le droit commun
  • Europe – Researchers develop 3D model of bone marrow
  • France – Passe sanitaire, données Covid-19 versées au SNDS: les mesures informatiques de la loi de sortie de l’état d’urgence sanitaire
  • Europe – Passe sanitaire européen: Bruxelles met son « service de passerelle » en route
  • France – La Cnam lance « Data vaccin Covid », son site en open data pour suivre la couverture vaccinale
  • International – Israel finds a ‘probable link’ between Pfizer vaccine and myocarditis cases
  • China – Sinovac’s COVID-19 vaccine receives WHO emergency use listing
• Catégorie : Formations
  • WEBINAR – Quality By Design (QbD) : Comprendre les bases, les aspects réglementaires et son application au développement d’un produit : production (ICH Q8) et analytique (ICH Q14)
  • WEBINAR – Impuretés : Comment faire son analyse de risque pour les impuretés élémentaires et les nitrosamines ?
  • WEBINAR – Développement de vaccins et thérapeutiques à base d’ARNm : Potentialités, Contraintes CMC et réglementaires

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• Category Formations IFEP