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  • UK – GSK’s Omjjara recommended by NICE to treat myelofibrosis patients with anaemia
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023
  • France – Martine Wonner suspendue pour un an par l’ordre des médecins
• Catégorie : Médicaments
  • UK – Sparsentan approved to treat adult patients with primary immunoglobulin A nephropathy (IgAN)
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
  • Europe – Leqembi recommended for treatment of early Alzheimer’s disease
  • USA – FDA proposes removing oral phenylephrine from use in nasal decongestants
  • UK – NHS rolls out ‘stop-smoking’ pill to help tens of thousands quit
  • UK – NICE recommends Blueprint Medicines’ Ayvakyt to treat rare blood disorder
  • UK – NICE recommends remote monitoring technology for heart failure patients
  • France – Mettre à disposition les informations et données autour du médicament aux patients et aux professionnels de santé afin de favoriser un meilleur usage des médicaments
  • UK – Pfizer’s Elrexfio recommended by NICE to treat relapsed and refractory multiple myeloma
  • Europe – EMA proposes updated guideline on peripheral arterial occlusive disease treatments
  • USA – FDA revises more than 800 PSGs in line with ICH M13A
  • UK – NICE recommendation for new Alexion PNH treatment
  • UK – NICE recommends Santen’s Roclanda to treat glaucoma and ocular hypertension
  • UK – AstraZeneca’s Voydeya recommended by NICE to treat rare blood disorder PNH
  • UK – Ipsen’s Iqirvo recommended by NICE to treat rare liver disease primary biliary cholangitis
  • UK – Eli Lilly’s Alzheimer’s drug Kisunla approved by MHRA but not recommended by NICE
  • UK – Merck’s Keytruda recommended by NICE to reduce risk of lung cancer recurrence
  • USA – FDA drafts guidance on drug interaction labeling
  • UK – Roche’s Alecensa receives NICE recommendation to treat ALK-positive lung cancer
  • Europe – Règlement d’exécution (UE) 2024/2699 de la Commission du 18 octobre 2024
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024
  • USA – Guidance : Core Patient-Reported Outcomes in Cancer Clinical Trials
  • Europe – EMA drafts concept paper for future radiopharmaceuticals guideline
  • UK – Johnson & Johnson receives updated NICE recommendation for Tecvayli in multiple myeloma
  • Europe – Seizing opportunities in a changing medicines landscape
  • France – Wegovy, le médicament vedette contre l’obésité de Novo Nordisk, est lancé en France
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October 2024
  • Europe – Improving efficiency of approval process for new medicines in the EU
  • UK – NICE Board says new method allowing greater weight to be given to severe diseases is working
  • UK – Roche’s injectable C5 inhibitor PiaSky recommended by NICE for rare blood disorder PNH
  • Europe – EMA adopts reflection paper on AI/ML in drug development
  • USA – FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
  • Europe – EMA recommends suspension of sickle cell disease medicine Oxbryta
  • USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials
  • USA – FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability
  • USA – Studies find uneven uptake of biosimilars as availability increases
  • Europe – Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
  • USA – FDA drafts guidance on multiregional clinical trials in oncology
  • USA – FDA updates guidance on classifying ANDA amendments for GDUFA III
  • Europe – EMA updates guideline on developing drugs for bipolar disorder
  • USA – FDA revises final guidance on nitrosamine impurities
  • UK – Relugolix for treating hormone-sensitive prostate cancer
  • UK – Emergency kits for people with adrenal insufficiency recommended to avoid hospital admission
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024
  • UK – MSD’s Welireg recommended by NICE to treat rare von Hippel-Lindau disease
  • UK – Novartis’ Fabhalta recommended by NICE to treat rare blood disorder PNH
  • UK – Theramex’s Eladynos recommended by NICE for post-menopausal bone disease
  • Europe – EMA guidance document on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare
  • Europe – Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
  • UK – BeiGene’s Brukinsa recommended by NICE to treat marginal zone lymphoma
  • USA – FDA unveils FY 2025 user fee rates
  • USA – FDA official clarifies misconceptions around RWE in premarket submissions
  • UK – Merck’s Keytruda combination recommended by NICE for advanced gastric cancer
  • Europe – Alzheimer : l’Europe dit non au lecanemab… l’Amérique dit oui
  • Europe – EMA addendum addresses vaccine development for immunocompromised people
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024
  • Europe – EMA advises about risks of using weight loss medicine Mysimba with opioids
  • UK – Boehringer Ingelheim’s Metalyse recommended by NICE to treat stroke in adults
  • USA – Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
  • UK – J&J’s Tecvayli recommended by NICE to treat relapsed and refractory multiple myeloma
  • France – Définition des conditions méthodologiques requises pour la prise d’un pari lors d’une demande d’accès précoce pré-AMM ou post-AMM conditionnelle, et sa levée – Note de cadrage
  • Europe – Development and manufacture of oligonucleotides – Scientific guideline
  • UK – NICE recommends Accord’s oral hormone therapy Orgovyx for advanced prostate cancer
  • Europe – EMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024- 2025
  • USA – FDA unveils rare disease innovation hub, plans public meeting this fall
  • USA – FDA guidance addresses developing treatments for pediatric IBD
  • USA – FDA makes exception for antibody drug conjugates in mass balance studies final guidance
  • USA – FDA issues final guidance user fees for combination products
  • France – Publication et entrée en vigueur de l’annexe 1 des bonnes pratiques de fabrication des médicaments stériles
  • Switzerland – Déclarations d’effets indésirables présumés de vaccins contre le COVID-19 évaluées en Suisse
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024
  • USA – FDA releases draft guidance on use-related risk analysis for combo products
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024
  • USA – FDA drafts guidance on essential outputs for drug delivery devices
  • Europe – EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era
  • USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
  • Europe – Commission authorises Chikungunya vaccine and funds new mosquito eradication programme
  • Europe – Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products – Scientific guideline
  • Europe – Clinical investigation of recombinant and human plasma-derived factor IX products – Scientific guideline
  • Europe – First nasal adrenaline spray for emergency treatment against allergic reactions
  • Europe – Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension
  • UK – Responding to new final draft guidance from NICE for a new gene therapy for haemophilia B
  • Europe – EU actions to tackle shortages of GLP-1 receptor agonists
  • Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments
  • Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
  • USA – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule
  • USA – FDA finalizes guidance on drug development for diabetic foot infections
  • Europe – Faster access to clinical trial information in Europe
  • USA – FDA finalizes guidance giving ANDA facilities time to comply with cGMP
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024
  • France – Vaccination maternelle contre le VRS : une nouvelle possibilité pour protéger le nouveau-né
  • Europe – Two new advice pilots to improve clinical trials in Europe
  • Europe – Annual report 2023
  • USA – FDA issues draft guidances covering BIMO inspections
  • USA – AAM seeks clarity, leeway in BA/BE studies guidance
  • USA – Experts, FDA officials discuss future of clinical trials
  • France – Acide hyaluronique : les autorités sanitaires renforcent la réglementation en rendant la prescription médicale obligatoire
  • Europe – Procedural advice on paediatric applications
  • UK – New restrictions on puberty blockers
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024
  • Europe – First vaccine to protect adults from Chikungunya
  • Europe – New gene therapy treatment for haemophilia B
  • USA – FDA plans to release AI drug development guidance this year
  • Europe – Commission approves up to €1 billion of State aid by six Member States for the first Important Project of Common European Interest in the health sector
  • Europe – Commission facilitates faster access to medicines with clear rules for joint clinical assessments
  • USA – FDA issues platform technology designation draft guidance
  • UK – Researchers combine herpes virus with cancer vaccine to treat brain cancer in children
  • France – L’ANSM inscrit de nouveaux cannabinoïdes sur la liste des stupéfiants
  • USA – Glioblastome : un essai vaccinal prometteur
  • Europe – EMA revises Q&A guidance on drug-device combination products
  • Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
  • USA – Stakeholders provide feedback on FDA draft guidance on drug development for early Alzheimer’s disease
  • Europe – Hydroxyprogesterone caproate medicines to be suspended from the EU market
  • Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
  • USA – FDA unveils draft guidance on REMS logic models
  • USA – FDA exploring model master files to expedite generic drug development
  • UK – New cabotegravir formulations approved to help prevent HIV-1 infection in adults and adolescents
  • USA – Emerging technologies and regulatory agency guidance for CGTs
  • USA – FDA drafts two guidances on safety testing for cell and gene therapy products
  • USA – FDA issues three guidances to expand cancer clinical trial eligibility
  • USA – FDA issues long-awaited LDT final rule
  • Europe – Guidance : Anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans (body and Annexes 4 and 6)
  • USA – FDA updates guidance on promotional labeling and advertising of biosimilars
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024
  • UK – 170,000 people in England to have further treatment choice for preventing migraine attacks.
  • UK – Children and teenagers with an aggressive form of brain cancer set to benefit after NICE recommends new life-extending drug combination treatment
  • USA – CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated approval guidance
  • Europe – EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs
  • Europe – New recommendations to strengthen supply chains of critical medicines
  • USA – FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
  • USA – FDA launches new clinical trial center to improve innovation, communication
  • Europe – Parliament adopts its position on EU pharmaceutical reform
  • Europe – Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) – Scientific guideline
  • USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates – Final Guidance for Industry
  • France – Expérimentation du cannabis médical : quelle continuité de la prise en charge ?
  • USA – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies: Guidance for Industry
  • USA – Center for Drug Evaluation and Research – Office of Pharmaceutical Quality : 2023 Annual Report
  • USA – Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks
  • USA – FDA turns attention to data integrity lapses at testing sites in new guidance
  • USA – FDA finalizes guidance on electronic submission of BA/BE adverse event reports to FAERS
  • USA – FDA Approves New Antibiotic for Three Different Uses
  • USA – FDA shifts IND safety reporting over to FAERS in finalized guidance
  • USA – FDA launches new Quantitative Medicine Center of Excellence
  • USA – FDA reduces number of samples to retain for BA/BE testing
  • Europe – European Commission proposes updates to medical device phthalates guidelines
  • Europe – EU recommendations for 2024/2025 seasonal flu vaccine composition
  • New Eealand – New Zealand updates pharmacovigilance guideline
  • Europe – EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials
  • Europe – EMA Management Board: highlights of March 2024 meeting
  • France – Paxlovid (nirmatrelvir/ritonavir) : rappel des interactions médicamenteuses avec certains immunosuppresseurs, notamment le tacrolimus, pouvant être fatales
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024
  • Europe – Regulatory requirements for conditional marketing authorization ‘evolving’
  • USA – FDA offers guidance on observational studies as RWE
  • USA – FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
  • USA – FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
  • USA – Industry clamors for clarity on FDA’s advanced manufacturing designation program
  • Europe – Environmental risk assessment of medicinal products for human use
  • Europe – Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
  • USA – FDA proposes rule for difficult-to-compound drugs, drug categories
  • UK – New treatment option available today for womb cancer
  • Europe – EU pharmaceutical policy: MEPs support comprehensive reform
  • USA – FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
  • Europe – European Parliament committee proposes changes to pharma legislation
  • USA – FDA offers guidance on minor label changes for OTC drugs
  • Europe – EU regulators and industry clash on pharmaceutical reform package
  • Europe – Commission proposes new measures for the better lifecycle management of medicine authorisations
  • USA – FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease
  • USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer
  • Europe – Procedural advice for orphan medicinal product designation
  • France – Forfait innovation : une 1ère technologie de santé inscrite au remboursement par l’Assurance maladie
  • Europe – European Commission proposes framework for joint clinical assessments
  • UK – UK’s MHRA approves first drug under international recognition procedure
  • USA – Cell therapy equipment: regulatory guidelines and feedback opportunities
  • USA – FDA updates early Alzheimer’s drug development guidance to add support for biomarkers, surrogate endpoints
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024
  • France – La HAS actualise la stratégie de vaccination contre le zona
  • Europe – DARWIN EU® continues expanding its capacity to deliver real-world data studies
  • Switzerland – Nouvelles autorisations de médicaments complémentaires et de phytomédicaments
  • France – Cannabis médical : point d’étape sur la dernière année de l’expérimentation et l’arrivée de médicaments à base de cannabis
  • USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry
  • USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy, and more
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024
  • USA – Industry urges FDA to do more to help companies prepare for DSCSA
  • UK – Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata
  • USA – FDA warns industry about potential data integrity issues with third-party labs
  • Europe – EMA proposes new guideline on non-inferiority trials
  • Switzerland – Swiss Medtech soutient les négociations concernant un paquet d’accords bilatéraux lll
  • USA – FDA finalizes guidance on charging for investigational drugs
  • USA – FDA issues new draft guidance on data monitoring committees
  • Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
  • Europe – Evaluation of medicinal products indicated for treatment of bacterial infections
  • UK – NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024
  • Europe – Progress update on pilot for academic and non-profit developers of advanced therapy medicines
  • UK – Brainomix’s AI-enabled stroke software endorsed by NICE
  • UK – Illegal medicines worth more than £30 million seized in the UK in 2023
  • UK – Updated NICE guidance recommends more targeting of antibiotics to those at the highest risk of suspected sepsis 
  • USA – FDA modernizing pharmacovigilance oversight with AI tools
  • USA – FDA finalizes best practices guide for postmarketing safety studies
  • Europe – EMA proposes waiving comparative efficacy studies for certain biosimilars
  • Europe – Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
  • USA – Clinical trials: FDA proposes new standards for collecting race, ethnicity data
  • UK – Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas
  • USA – FDA issues QMSR final rule with 2-year transition period
  • Europe – Clinical trials’ transition to new EU system – one year left
  • USA – FDA: Genome editing therapies may use accelerated approval pathway
  • Europe – Experts outline challenges of combination products in Europe
  • USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety prob
  • USA – FDA updates guidance on remote regulatory assessments
  • Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024
  • Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
  • Europe – EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
  • USA – FDA final guidances aim to streamline ANDA reviews
  • UK – NICE recommends two AI-powered software tools for stroke diagnosis in NHS
  • Europe – User guide for micro, small and medium-sized enterprises
  • USA – Growing interest in modeling prompts launch of MIE program for generic drugs
  • UK – MHRA introduces new restrictions for fluoroquinolone antibiotics
  • UK – Pfizer’s Talzenna recommended by NICE for advanced breast cancer
  • France – Essais cliniques de médicaments : toutes les demandes de transition doivent être déposées sur le portail CTIS
  • Europe – Human medicines: highlights of 2023
  • Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
  • UK – Pfizer’s COVID-19 antiviral Paxlovid recommended by NICE for expanded use
  • Europe – Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
  • USA – FDA updates draft guidance on division-level ANDA disputes
  • Europe – EMA explains how tweaked Brexit deal will affect medicinal products
  • USA – FDA issues final guidance on rare disease drug development
  • USA – Novel Drug Approvals for 2023
  • USA – Industry groups seek changes to FDA’s remote interactive evaluation guidance
  • USA – FDA CGT draft guidance focuses on potency assurance strategy
  • USA – FDA adds microbiological assessments to ophthalmic drug quality guidance
  • USA – FDA issues final guidance on major statement in DTC ads
  • USA – FDA finalizes guidance to limit use of benzene in drug products
  • Canada – Notice – Implementation of ICH E19: A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
  • USA – FDA proposes master control trial guidance that goes beyond COVID-19
  • USA – Stakeholders concerned with FDA’s definition of labeling in PDURS guidance
  • USA – FDA finalizes guidances on RWD in regulatory submissions, assessing registries
  • UK – AstraZeneca/Merck’s Lynparza recommended by NICE for advanced prostate cancer
  • USA – FDA proposes updated medtech RWE guidance
  • Brazil – ANVISA approves skinny labeling in Brazil
  • Europe – EU agencies adopt workplan on AI in medicines regulation
  • USA – FDA establishes advisory committee for genetic metabolic disease treatments
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023
  • USA – FDA guidance details new advanced manufacturing technology designation program
  • USA – Experts discuss red flags that can trigger legal action against drug and device makers
  • Europe – First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
  • Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines
  • USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR and LDT rules
  • USA – FDA finalizes guidance on DSCSA verification systems
  • UK – AstraZeneca/Merck’s Lynparza combination recommended by NICE for advanced ovarian cancer
  • USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
  • France – L’agence du médicament sonne l’alarme au sujet de réactions allergiques associées à un antiseptique
  • USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
  • USA – Combination products: Non-harmonized regulations are hurting manufacturers
  • UK – Pfizer’s RSV vaccine granted MHRA approval to protect infants and older adults
  • USA – FDA outlines process for recognizing standards for regenerative medicines
  • UK – MHRA instructs health organisations to prepare now for new measures to reduce ongoing serious harms of valproate
  • Europe – Pharma groups fight proposed ban on titanium dioxide in Europe
  • UK – AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in infants
  • USA – Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling
  • USA – FDA issues new standards for DTC prescription drug ads
  • USA – Global Pharma’s eye drops contaminated with “filth” while Amazon made unapproved claims for eye drops
  • USA – Industry calls for revisions in FDA’s CGT manufacturing change guidance
  • UK – MHRA authorises world-first gene therapy for two inherited blood disorders
  • France – Levothyrox et médicaments à base de lévothyroxine : information concernant la disponibilité d’Euthyrox
  • France – Trois bases de données médicamenteuses obtiennent l’agrément version 3 de la HAS
  • Europe – EMA seeks feedback on clinical development of vaccines for immunocompromised people
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023
  • UK – NICE recommends Chiesi’s alpha-mannosidosis enzyme replacement therapy
  • USA – FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus
  • USA – FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
  • Europe – First electronic product information (ePI) published for selected human medicines
  • USA – FDA finalizes guidance on real-time review of oncology drugs
  • UK – MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post-menopausal women
  • USA – FDA publishes two guidances on collecting clinical outcomes data
  • USA – FDA moving in the right direction with psychedelic drug guidance
  • USA – FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas
  • USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing
  • USA – FDA won’t extend LDT rule comment period
  • Europe – EMA encourages companies to submit type I variations for 2023 in November 2023
  • USA – FDA expands KASA review program to drug substances
  • Europe – EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
  • USA – FDA expands scope of off-label guidance to include presentations from reprints
  • USA – Dems urge free OTC birth control while GOP fights to ban mail-order abortion pill
  • Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
  • UK – Novartis’ Cosentyx recommended by NICE for hidradenitis suppurativa
  • USA – FDA addresses use of remote interactive evaluations in post-pandemic era
  • Europe – EMA takes further steps to address critical shortages of medicines in the EU
  • USA – FDA finalizes guidance on considerations for evaluating drug’s benefits and risks
  • Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens
  • UK – NICE recommends Roche’s Columvi for advanced lymphoma in UK
  • France – FDA guidance calls for testing all alcohol-based products for methanol
  • USA – FDA offers guidance on development of antimicrobials for diabetic foot infections
  • USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2023
  • UK – Guidance : Full pack dispensing of valproate-containing medicines
  • Latin America – Brazil, Mexico launch efforts to ease biosimilar regulation
  • Europe – Convergence: EMA official urges transition of existing clinical trials to CTIS portal
  • USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
  • USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
  • USA – FDA offers first guidance on stimulant use disorder drug development
  • Europe – EMA Management Board: highlights of October 2023 meeting
  • USA – FDA updates policies for reviewing ANDAs
  • USA – FDA finalizes guidance on dose banding for injectables
  • USA – FDA guidance explores trial design, supporting data for GVHD treatments
  • USA – FDA adds breakpoint updates to antimicrobial susceptibility test system device labeling guidance
  • 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
  • France – Chimiothérapies par fluoropyrimidines (5-FU) : l’Institut et la HAS actualisent leurs recommandations sur la recherche du déficit en enzyme DPD
  • Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS ban
  • USA – CBER revises internal procedures for processing clinical holds, NDAs and BLAs
  • Europe – Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs a year, report claims
  • Switzerland – Swissmedic updates adverse event reporting requirements for 2024
  • UK – Guidance : Drug Safety Update: monthly PDF newsletter
  • UK – NICE nod for Darzalex with lenalidomide and dexamethasone
  • USA – FDA guidances keep coming, new device harmonization plan, and more
  • USA – FDA releases guidance on labeling of drug use-related software outputs
  • Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
  • USA – FDA guidance on conducting trials during emergencies shifts away from COVID-19
  • UK – COVID-19: guidance for people whose immune system means they are at higher risk
  • UK – NICE recommends more genetic testing for links to ovarian cancer
  • USA – FDA expands types of acceptable confirmatory evidence in new guidance
  • France – Médicaments à base de miansérine : rappel du bon usage et des risques d’effets indésirables graves notamment chez les patients âgés
  • USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels
  • UK- Pfizer’s Vydura recommended by NICE for acute migraines
  • France – La campagne de vaccination contre le Covid-19 avancée au 2 octobre alors que la circulation du virus augmente en France
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023
  • France – L’ANSM classe plusieurs vaccins sur la liste I des substances vénéneuses
  • Europe – EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
  • Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
  • USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug products
  • Europe – Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
  • USA – FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
  • UK – Eli Lilly’s Mounjaro receives NICE recommendation to treat type 2 diabetes
  • UK – NICE issues two recommendations for UCB’s inflammatory disease drug
  • France – Vaccination contre le Covid-19 et maternité
  • New Zealand – Guidelines on the Regulation of Therapeutic Products in New Zealand
  • USA – FDA finalizes guidance on use of human factors studies in combination product development
  • USA – FDA draft guidance focuses on postapproval trial diversity data
  • USA – FDA finalizes guidance on standards for tracing products through supply chain
  • USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III
  • UK – MHRA approves Pfizer/BioNTech’s adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5
  • UK – Guidance published on the new international regulatory recognition routes for medicines approvals
  • UK – NICE recommends Chiesi’s Elfabrio for adults with Fabry disease
  • USA – FDA publishes additional guidances on delay of enforcing DSCSA electronic tracking requirements
  • Europe – PRAC recommends new measures to avoid topiramate exposure in pregnancy
  • Europe – COVID-19: Commission authorises adapted COVID-19 vaccine for Member States’ autumn vaccination campaigns
  • USA – FDA finalizes guidance on real-world evidence in drug approvals
  • Europe – Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
  • UK – NHS world first rollout of cancer jab that cuts treatment time by up to 75%
  • USA – Psychedelic drug trial guidance: Commenters see vital role for psychotherapy
  • UK – Nitrosamines impurities in medicines
  • UK – NICE recommends Amryt’s Filsuvez for rare skin disorder
  • USA – FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
  • USA – Bacterial endotoxin testing of drugs and biologics in the US: Ensuring patient safety
  • UK – NICE gives green light for MSD’s Keytruda
  • Europe – EMA review of data on paternal exposure to valproate
  • USA – FDA issues final guidance on obtaining informed consent in drug and device clinical trials
  • USA – FDA drafts guidance on classification category for biosimilar supplements
  • Europe – Revocation of authorisation for sickle cell disease medicine Adakveo
  • USA – QTc: FDA proposes labeling for heart drugs with heart rhythm risk
  • USA – FDA sets acceptable intake limits for nitrosamines in drugs
  • USA – FDA finalizes guidance on DSCSA waivers, exceptions and exemptions
  • USA – Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance
  • Europe – EMA updates Q&A document on publication of clinical trial data
  • Canada – Notice: Release of (Step 4) ICH S12 Guideline – Nonclinical Biodistribution Considerations for Gene Therapy Products
  • UK – NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy
  • USA – FDA approves second over-the-counter naloxone nasal spray for opioid overdose
  • USA – Pharmaceutical distributors seek two-year delay in DSCSA tracking rules
  • USA – Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda
  • USA – FDA finalizes guidance on drug quality consensus standards recognition program
  • Europe – Paving the way towards coordinated clinical trials in public health emergencies in the EU
  • Europe – Review: real-world data studies
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023
  • Europe – First RSV vaccine to protect infants up to 6 months of age and older adults
  • Europe – Reflection paper on the use of artificial intelligence in the lifecycle of medicines
  • France – Traitement de l’acné sévère : mieux faire connaître les risques associés à l’isotrétinoïne orale
  • USA – FDA issues draft guidance on reporting manufacturing changes for gene therapies
  • USA – FDA Approves New Drug to Prevent RSV in Babies and Toddlers
  • USA – FDA revises IEM drug draft guidance to clarify food standards, use of control groups
  • Europe – European Health Union: EU steps up action to prevent shortages of antibiotics for next winter
  • USA – FDA Approves First Nonprescription Daily Oral Contraceptive
  • USA – Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
  • USA – Postmarketing requirements: FDA drafts guidance on determining non-compliance
  • Europe – EMA statement on ongoing review of GLP-1 receptor agonists
  • USA – FDA describes agency’s initiatives to accommodate growth in cell and gene therapy fields
  • France – Stratégie de vaccination contre la Covid-19 : actualisation des recommandations relatives à l’administration concomitante des vaccins contre la Covid-19 et contre la grippe saisonnière
  • USA – Stakeholders want consistency, more examples in last FDA draft guidance on patient-focused drug development
  • UK – Novavax COVID-19 vaccine produces immunity
  • 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
  • Europe – Clinical Trials Information System (CTIS) – Sponsor Handbook
  • Australia – Nitrosamine risk assessment in Category 1 prescription medicine registration applications
  • Europe – Phasing out of extraordinary COVID-19 regulatory flexibilities
  • Europe – Global regulators confirm good safety profile of COVID-19 vaccines
  • UK – BMS’ Sotyktu gets NICE green light for NHS use
  • France – Clomid (citrate de clomifène) : le traitement doit être arrêté en cas d’altération de la vision
  • Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus
  • USA – FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
  • USA – FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional labeling, ads
  • USA – FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine
  • UK – Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis
  • Europe – Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations
  • Europe – Use of real-world evidence in regulatory decision making – EMA publishes review of its studies
  • USA – FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023
  • USA – Pharmacogenomic data guidance: Industry objects to reporting exploratory studies
  • USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022
  • Europe – ACT EU: creating a better environment for clinical trials through collaboration
  • USA – FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy
  • USA – Generic drug lobby details extent of US shortages, offers possible solutions
  • Europe – Report: How EU ensured safety of medicines during COVID-19
  • USA – FDA pilot aims to boost transparency for oncology tests
  • USA – FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
  • USA – FDA details policy on facility reclassification requests under GDUFA III
  • France – Relocalisations de médicaments essentiels – Dossier de presse le 13/06/2023
  • Europe – European Health Union: EU steps up the fight against antimicrobial resistance
  • USA – Guidance details updated FDA GDUFA fees, structure and appeals process
  • Europe – Guidance on paediatric submissions
  • USA – FDA officials say high priority will be given to applications with endpoints that can be leveraged for other rare diseases
  • Europe – EMA Management Board: highlights of June 2023 meeting
  • USA – Manufacturers seek clarity on FDA’s drug shortage notification guidance
  • UK – NICE nod for AstraZeneca’s Lynparza
  • France – L’ANSM classe l’hexahydrocannabinol (HHC) et deux de ses dérivés sur la liste des stupéfiants
  • USA – FDA seeks feedback on ICH E6(R3) GCP guideline
  • USA – FDA officials: ‘Significant work’ still needed for rare disease drug development
  • Europe – EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
  • Switzerland – New COVID-19 vaccine successfully tested
  • USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
  • USA – Accelerated approval trials: Commenters seek details on single-arm considerations
  • USA – FDA finalizes drug-drug interaction guidance for therapeutic proteins
  • USA – FDA issues draft guidance on developing migraine prevention drugs
  • USA – FDA considers new efficacy endpoint for diabetes drugs
  • UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
  • 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
  • France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves
  • 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
  • France – L’ANSM suspend la commercialisation des produits Trex Tea, Trex Caps et Trex Plus
  • 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
  • France – Les contre-indications à la vaccination contre le Covid-19
  • 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
  • France – Bronchiolite : Moderna annonce des résultats positifs pour son vaccin
  • 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
  • France – Gustave-Roussy choisit Synapse Medicine pour sécuriser ses prescriptions complexes
  • 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
  • International – Contre le Covid-19, l’exécutif mise aussi sur le Paxlovid, l’antiviral de Pfizer
  • 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
  • France – Fiche bon usage des médicaments antiémétiques dans le traitement symptomatique des nausées et des vomissements
  • 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?
  • France – Sérialisation: vers une pénalité trimestrielle et reconductible de 2.000€ pour les officinaux
  • 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
  • Catégorie : International
    • International – Mpox : l’OMS approuve un second vaccin, fabriqué par une société pharmaceutique japonaise
    • International – Industry stakeholders call for changes to ICH M14 RWD guideline
    • India – National Regulatory Authority of India meets WHO international standards for vaccine regulations
    • International – The ICH E11A Guideline reaches Step 4 of the ICH Process
    • International – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
    • International – VIH : un médicament préventif efficace, avec deux injections par an seulement, suscite l’enthousiasme
    • International – WHO publishes guidance for HPV vaccine developers to help tackle cervical cancer
    • International – ICH announces forthcoming documents on nitrosamine impurities, RWD
    • International – ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance on RWD
    • International – WHO recommends risk management plans for high-risk excipients
    • International – WHO issues guidance on nitrosamine controls in drug manufacturing
    • International – ICH M13A BE testing guideline expected to be adopted this summer
    • International – ICH E2D(R1) Guideline on post-approval safety data: definitions and standards for management and reporting of individual case safety reports Step 2b
    • International – ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management »
    • International – ICH targets cell and gene therapies, real-world data as topics ripe for harmonization
    • International – ICH consults on revised post-approval safety guideline that accounts for digital platforms
    • International – Regulators, industry tout new approach for benefits-risk assessments
    • International – ICH Q14 Analytical procedure development – Scientific guideline
    • International – ICH Q2(R2) Validation of analytical procedures – Scientific guideline
    • International – WHO decision improves children’s access to safer polio vaccine
    • International – The subjectivity of starting materials in the era of harmonization
    • International – ICH adopts guidelines on viral safety evaluation and analytical method development
    • International – ICH releases Q9 training materials on quality risk management
    • International – WHO releases key regulatory considerations on AI for health
    • International – Convergence: Confusion lingers over interchangeability and switching of biosimilars
    • International – The WHO anatomical therapeutic chemical/defined daily dose toolkit
    • International – E-labeling and digital transformation in healthcare
    • International – FDA announces completion of first joint assessment with EMA in ICMRA pilot
    • International – WHO proposes best practices for clinical trials
    • International – WHO seeks to align biowaiver policy with ICH guidelines
    • International – ICH paper calls for ‘stepwise’ harmonization of RWE
    • International – ICH charts new topics, touts progress in updating existing guidelines
    • International – Genetically altered vaccines developed to help eradicate polio
    • 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
  • Catégorie : France
  • Catégorie : Europe
    • Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
  • Catégorie : Amériques
    • USA – FDA issues draft guidance on dosage and administration labeling
  • Catégorie : Asie-Pacifique
  • Catégorie : Découverte
• Catégorie : DM-DIV
  • UK – Medical Devices Regulations: Routes to market and in vitro diagnostic devices
  • Europe – MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • Europe – Experts: Notified body survey shows MDR/IVDR progress despite some snags
  • Europe – Q&A Obligation to inform in case of interruption or discontinuation of supply
  • USA – Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing: A White Paper for Medical Device Manufacturers
  • Europe – Notified body official shares recommendations for successful PMCF plans
  • Europe – MDCG 2022 – 5 Rev. 1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices – October 2024
  • Europe – MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices – October 2024
  • UK – UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?
  • Europe – EMA official reports on scientific advice pilots for high-risk and orphan devices
  • Europe – Team-NB views on implementation of MDR/IVDR Regulations
  • Europe – Urgent need to revise the medical devices regulation
  • Europe – Stakeholders disagree over need for ‘urgent action’ on MDR/IVDR
  • UK – Implementation of medical devices future regime : Implementation of the future regulations – Updated 22 October 2024
  • Europe – Règlement d’exécution (UE) 2024/2699 de la Commission du 18 octobre 2024
  • Europe – Open letter to Stella Kyriakides on the urgent need for action on the medical technology regulations
  • Australia – How to submit a custom-made medical device / patient-matched medical device notification – Step-by-step guide
  • Australia – Understanding personalised medical devices rules (including 3D-printed devices) – Regulatory changes for custom-made medical devices
  • Australia – Refinements to the Personalised Medical Device Framework
  • Europe – MDCG 2021-25 Rev. 1 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
  • UK – MHRA to launch consultation on device international reliance plan by year’s end
  • Canada – Health Canada digital health head says AI/ML guidance imminent
  • Europe – Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects
  • Europe – Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products
  • Europe – MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
  • Europe – MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams – October 2024
  • UK – MHRA e-cigarette and vape products regulator profile
  • UK – An update on our plans for Med Tech regulatory change
  • Europe – Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746
  • Europe – MDCG 2021-4 rev.1 – Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 – September 2024
  • USA – FDA names new head of medical device evaluation and quality
  • USA – FDA releases three post-pilot ASCA draft guidances
  • Europe – Notification of a Body in the framework of a technical harmonization directive
  • USA – FDA Authorizes First Over-the-Counter Hearing Aid Software
  • USA – Industry groups call for changes to FDA’s guidance on use-related risk analyses
  • Canada – The evolution of Canada’s medical device regulatory framework
  • USA – FDA updates patient preference guidance to span the product life cycle
  • Europe – EU Update: Current State of Medical Device Regulations
  • Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards for medical devices
  • Europe – New pilot programme to support orphan medical devices
  • USA – FDA unveils FY 2025 user fee rates
  • Europe – Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
  • USA – FDA finalizes COVID-era guidance on container closure changes
  • Europe – Medical device competent authority statement on the status of the EU regulatory system
  • Europe – Règlements européens relatifs aux dispositifs médicaux et de diagnostics in vitro : publication d’un « consensus statement » à destination de la Commission européenne
  • Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards for medical devices
  • China- Medical Device Administrative Control System (MDACS)
  • USA – FDA issues final guidance user fees for combination products
  • USA – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
  • Europe – Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024
  • USA – FDA releases draft guidance on use-related risk analysis for combo products
  • Europe – Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024
  • Europe – MDCG 2020-16 Rev.3 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – July 2024
  • USA – FDA drafts guidance on essential outputs for drug delivery devices
  • UK – Medical devices: UK approved bodies
  • Europe – MDCG 2021-5 Rev. 1 : Guidance on standardisation for medical devices
  • USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
  • Europe – MDCG 2024-10 Clinical evaluation of orphan medical devices
  • Switzerland – Swissmedic prepares medtech industry for activation of medical devices database module
  • Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments
  • Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
  • Europe – Phthalates in certain medical devices: updated SCHEER guidelines published
  • Australia – Medical device regulation changes
  • Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies – June 2024
  • Europe – MDCG 2024-1-5 : Guidance on the vigilance system for CE-marked devices DSVG 05 : Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence
  • Europe – Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices in the EU
  • Europe – Annual report 2023
  • Europe – Medical devices: Council adopts new measures to help prevent shortages
  • Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
  • Europe – MDCG 2022-4 Rev 2 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
  • Switzerland – Des paralytiques retrouvent l’usage de leurs mains grâce à un dispositif de stimulation externe
  • UK – Home testing devices could increase the number of people diagnosed with sleep condition
  • UK – MHRA announces a proposed framework for international recognition of medical devices
  • Europe – EMA revises Q&A guidance on drug-device combination products
  • Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
  • Europe – Medical devices: new guidance for industry and notified bodies
  • UK – EM on EU regulations 2017/745 & 2017/746 (COM(2024)43)
  • USA – FDA concerned about potential device shortages due to new EtO limits
  • Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
  • USA – FDA issues long-awaited device remanufacturing guidance
  • UK – MHRA’s AI Airlock to address challenges for regulating AI medical devices
  • Europe – Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics
  • UK – MHRA expected to launch recognition framework for devices
  • Europe – Désignation d’AFNOR Certification dans le cadre du règlement UE 2017/745, relatif aux dispositifs médicaux
  • USA – FDA publishes new dataset to aid medical device biocompatibility testing
  • Brazil – Brazil to recognize other agencies’ decisions on devices
  • Europe – MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
  • Europe – MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
  • Europe – TÜV SÜD Danmark ApS today received its designation as Notified Body 2443 under Medical Device Regulation 2017/745 by the Danish Medicines Agency (DKMA)
  • Europe – Update : MDCG 2022-9 rev.1 – Summary of safety and performance template – April 2024
  • USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
  • Europe – Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market – Final report
  • USA – FDA criticized for approval of genetic test for opioid addiction risk
  • UK – Regulation of devices in Northern Ireland
  • USA – Medical Device Development Tools (MDDT)
  • UK – NHS rolls out artificial pancreas in world first move
  • Europe – NF EN ISO 20916 – Mars 2024 – Dispositifs médicaux de diagnostic in vitro – Études des performances cliniques utilisant des prélèvements de sujets humains – Bonnes pratiques d’étude
  • Europe – Request for a scientific opinion on risks for the health associated to the use of brain stimulators not having an intended medical purpose described in the group 6 of Annex XVI to Regulation (EU) 2017/745
  • USA – FDA proposes animal study requirements for dental bone grafts
  • USA – Device makers ask FDA for clarification, exceptions to metallic coating guidance
  • UK – MHRA warns of unsafe counterfeit anti-choking devices
  • USA – FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
  • Europe – Recent ECJ ruling could lead to standards development tumult
  • USA – FDA panel’s green light on glaucoma wearable device offers hope in sight
  • USA – FDA wants sponsors to test devices that may cause tissue temperature changes
  • USA – FDA warns consumers against using plastic syringes made in China
  • Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing
  • USA – EPA finalizes rule to reduce EtO emissions from sterilization facilities
  • USA – FDA proposes updates to device cybersecurity guidance
  • Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
  • Europe – New Notified Body Designated Under EU MDR
  • Europe – Normes Harmonisées 2024/817
  • Europe – Normes Harmonisées 2024/815
  • UK – New action to tackle ethnic and other biases in medical devices
  • USA – FDA official discusses use cases, limits for device PCCPs
  • usa – Industry calls for changes in FDA’s RWE guidance for devices
  • USA – FDA official warns device makers over supply chain risks
  • Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux DM
  • Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech legislation
  • Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
  • USA – FDA proposes down-classifying most high-risk IVDs
  • Europe – Experts outline challenges of combination products in Europe
  • Europe – MDCG endorsed documents and other guidance
  • USA – FDA updates guidance on remote regulatory assessments
  • Europe – User guide for micro, small and medium-sized enterprises
  • USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
  • USA – FDA proposes guidance on orthopedic product coatings
  • Europe – Commission proposes measures to improve the availability of in vitro diagnostics
  • Europe – Regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC
  • Europe – Overview of language requirements for manufacturers of medical devices
  • UK – Medical devices: UK approved bodies
  • UK – Implementation of medical devices future regime
  • USA – FDA updates sterilization category to encourage vaporized hydrogen peroxide use
  • Canada – Amendments to the Medical Devices Regulations to address future public health emergencies
  • Europe – MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence
  • Switzerland – New organisational structure with separate Medical Devices Surveillance Sector
  • UK – Heart vests to identify those at high risk of sudden cardiac death
  • UK- Wearable technology to be offered to thousands with type 1 diabetes in UK
  • USA – FDA updates third party 510(k) guidance
  • Europe – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025 deadline for Class D IVDs
  • 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 – MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products : A guide for manufacturers and notified bodies
  • Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
  • Europe – Update – MDCG 2021-6 – Rev.1 – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation – December 2023
  • USA – Experts discuss red flags that can trigger legal action against drug and device makers
  • Europe – Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
  • USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR and LDT rules
  • USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
  • USA – Device cybersecurity must be a priority from design through retirement, experts say
  • Europe – MDCG raises alarm over lack of MDR, IVDR applications
  • USA – Combination products: Non-harmonized regulations are hurting manufacturers
  • USA – TCET pathway may broaden access to breakthrough devices, but reforms still needed
  • USA – Existing software development lifecycle tools can help speed AI/ML products to market
  • USA – Providing context to AI/ML products may address explainability says FDA
  • USA – Legacy devices report highlights need for data to support future policies
  • USA – FDA publishes final guidances on device shortage reporting, computational modeling
  • USA – Stakeholders not working together to develop AI standards, expert laments
  • Europe – Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
  • USA – Medtech expert says EU’s AI Act could face an uphill political battle
  • USA – Experts call for data transparency with recalled medical devices
  • USA – FDA highlights updated labeling for some surgical mesh products, cautions against use of mesh in breast surgery
  • Europe – The Future of Europe’s Medical Technology Regulations
  • Europe – Notified Bodies Survey on certifications and applications (MDR/IVDR)
  • New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
  • USA – FDA Clears First COVID-19 Home Antigen Test
  • USA – FDA recognizes three new international medical device software security standards
  • Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/746
  • Europe – 40ème organisme notifié au titre du règlement (UE) 2017/745
  • USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing
  • Europe – Notified body perspective: Evaluating uses for real-world data
  • USA – FDA extends regulatory flexibilities for PMA, HDE modifications
  • UK – MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers
  • Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
  • Europe – Experts outline current knowledge on AI and medical devices
  • UK – MHRA and international partners publish five guiding principles for machine learning-enabled medical devices
  • USA – FDA revises final guidance on modifying remote monitoring devices
  • Europe – In vitro diagnostic device regulation in Europe: Update on revisions
  • Europe – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
  • Europe – Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses
  • Europe – The European Medical Technology in Figures 2023
  • USA – FDA revises magnetic resonance guidance to reflect updated international standard
  • USA – FDA’s CDRH releases list of proposed guidances for FY 2024
  • USA – Diversity plan draft guidance on track before year end, FDA official says
  • USA – Convergence: Tips for when to include PCCPs in product submissions
  • USA – The biggest misconception regulatory professionals have about the FDA 510(k) program, according to Mark DuVal
  • Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist
  • USA – FDA updates physiologic closed-loop control final guidance with industry feedback
  • USA – FDA guidance explores trial design, supporting data for GVHD treatments
  • USA – New guidances outline eSTAR submission requirements for de novo and 510(k) device applications
  • USA – FDA proposes long-awaited LDT enforcement rule
  • USA – FDA premarket cybersecurity guidance clarifies SBOM requirements
  • Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs a year, report claims
  • USA – Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
  • USA – FDA guidances keep coming, new device harmonization plan, and more
  • UK – Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
  • USA – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
  • Europe – Ongoing consultations under the PECP
  • Europe – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices
  • USA – FDA weight-loss device guidances address clinical and non-clinical studies
  • USA – FDA’s final breakthrough devices guidance now includes technologies that address health disparities
  • USA – FDA updates medical device biocompatibility guidance with exclusion list
  • USA – Use of International Standard ISO 10993-1, « Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process »
  • USA – Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
  • USA – Evidentiary Expectations for 510(k) Implant Devices
  • USA – Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
  • Australia – Medical devices vigilance program pilot
  • USA – FDA finalizes guidance on use of human factors studies in combination product development
  • USA – FDA updates off-the-shelf software guidance to reflect least burdensome approach
  • USA – FDA details proposed 510(k) modernization with trio of draft guidances
  • Europe – Evaluation clinique : retours d’expérience d’un organisme notifié
  • UK – Three new UK Approved Bodies to certify medical devices announced by the MHRA
  • UK – Medical devices: UK approved bodies
  • Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR applications
  • USA – FDA issues final guidance on obtaining informed consent in drug and device clinical trials
  • UK – NICE recommends AI technologies for radiotherapy treatment planning
  • UK – Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the capsule around breast implants
  • Europe – MDR/IVDR survey shows NBs have increased capacity
  • USA – Opioid use disorder: FDA drafts guidance on clinical considerations for devices
  • UK – Implementation of medical devices future regime
  • USA – FDA recognizes new medical device sterilization standards
  • UK – Software and Artificial Intelligence (AI) as a Medical Device
  • Europe – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices REV. 1
  • USA – FDA warns device makers for GMP issues, unauthorized uses
  • Europe – European Commission approves updated regulation to ease contact lens UDI requirements
  • Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/745
  • Europe – Add 1 – MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
  • USA – Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules
  • Europe – Pediatricians push for urgent action to stop MDR from disrupting medical device supply
  • Europe – Règlement d’exécution (UE) 2023/1194 de la Commission du 20 juin 2023 modifiant le Règlement d’exécution (UE) 2022/2346 en ce qui concerne les dispositions transitoires pour certains produits n’ayant pas de destination médicale prévue dont la liste figure à l’Annexe XVI du Règlement (UE) 2017/745
  • USA – FDA drafts guidance to aid orthopedic implant guide makers
  • Europe – EUDAMED user guide : Economic Operators – Actor module
  • USA – Content of Premarket Submissions for Device Software Functions
  • Europe – MedTech Europe signs joint healthcare statement highlighting how the AI Act can give citizens the confidence to embrace AI-enabled medical technologies
  • Australia – New guidance published on manufacturer evidence for IVD medical devices
  • UK – MHRA issues new guidance on the use of life saving adrenaline auto-injectors
  • USA – FDA revamps device software premarket submissions guidance
  • USA – Joint FDA/VHA medical device pilot aims to create digital stockpiles, bolster distributed manufacturing technologies
  • USA – FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance
  • Canada – Proposed changes to the Medical Devices Regulations to address future public health emergencies: Notice
  • USA – AdvaMed calls for changes to FDA’s non-spinal bone fixation device guidance
  • USA – FDA finalizes guidance for containment system used with power morcellators
  • 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
  • Europe – Team-NB : Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
  • 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
  • Europe – Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation
  • 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
  • Europe – European Regulators Move to Increase Notified Body Capacity
  • 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 – 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 – Votre avis sur l’extension de la période de transition des RDM et RDMDIV ?
  • 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
  • UK – Artificial pancreas technology set to change lives
  • 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
  • Europe – The designation of notified bodies under the upcoming Artificial Intelligence Act
  • 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
  • Europe – European Commission Proposes Extending MDR, IVDR Transition Periods
  • 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
  • Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’
  • 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
  • Catégorie : International
    • International – RF Quarterly, September 2024: Artificial intelligence in medical devices
    • India – Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & Family Welfare becomes Affiliate Member of the International Medical Device Regulators Forum (IMDRF)
    • International – The global regulatory landscape for AI/ML-enabled medical devices
    • International – Artificial intelligence in medical devices
    • International – IMDRF Document Implementation Report – Final document
    • International – ISO/DIS 10993-1(en) Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
    • International – Lancement de la plateforme MeDevIS pour améliorer l’accès aux technologies et dispositifs médicaux
    • International – ISO/DIS 14155 will replace ISO 14155:2020
    • International – 1SO 10933-1:2018 will be replaced by ISO/DIS 10993-1
    • International – IMDRF publishes AI/ML guiding principles echoing US, UK, Canadian regulators
    • International – FDA, Health Canada, MHRA release guiding principles on transparency for machine learning medical devices
    • International – Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
    • International – Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
    • International – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
    • International – Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
    • International – Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
    • International – Final Document- Principles of Labelling for Medical Devices and IVD Medical Devices
    • International – FDA warns Philips about imaging device violations at China facility
    • International – IMDRF publishes new procedures on membership, governance
    • International – Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
    • International – IMDRF guidance updates thinking on personalized medical devices
    • International – E-labeling and digital transformation in healthcare
    • 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
  • Catégorie : France
    • France – Implants et prothèses dentaires : avis favorable de la HAS pour leur remboursement dans les édentements complet ou unitaire
    • France – La HAS émet un avis favorable à l’octroi d’un forfait innovation pour le test salivaire Endotest
    • France – La HAS réévalue les systèmes connectés de prise en charge du diabète
    • France – Analyse des déclarations de la base nationale des évènements indésirables graves associés aux soins (EIGS) en lien avec les dispositifs médicaux
    • France – Ballons gastriques Allurion : recommandations pour limiter la survenue de complications graves
    • France – Déclarer l’indisponibilité d’un dispositif médical : la procédure évolue
    • France – Le Grand Défi « Dispositifs médicaux numériques en santé mentale »
    • France – Acide hyaluronique : les autorités sanitaires renforcent la réglementation en rendant la prescription médicale obligatoire
    • France – Règlement européen relatif aux dispositifs médicaux : fin de la période de transition
    • France – Tests génétiques sur Internet : la CNIL appelle à la vigilance
    • France – DTx : la réglementation se met progressivement en place
    • France – Diagnostic complexe d’endométriose : la HAS propose un accès au test salivaire Endotest® dans le cadre du forfait innovation
    • France – Conception orientée production : que faire pour les DM les plus complexes ?
    • France – Conformité du marquage UDI : la norme ISO sur les Data Matrix évolue
    • France – Déodorant Nuud : retrait du marché par le fabricant de l’ensemble des lots de ce déodorant
    • France – HAS : Dispositifs médicaux numériques à usage professionnel
    • France – Laurence Comte-Arassus élue présidente du Snitem
    • France – Sécurisation des prescriptions: Vidal décroche le marquage CE classe IIb pour son logiciel de DM
    • France – Rapport annuel du Snitem – 2023
    • France – L’ANSM demande aux fabricants de dispositifs médicaux qui envoient un avis de sécurité d’y apposer le code-barres des dispositifs concernés
    • 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
  • Catégorie : Europe
    • UK – MHRA announces consultation on improved safety for high risk in vitro diagnostic devices
  • Catégorie : Amériques
  • Catégorie : Asie-Pacifique
  • Catégorie : Découverte
• Catégorie : Cosmétiques
  • Catégorie : France
    • France – L’ANSM suspend la commercialisation de produits cosmétiques de la marque Joëlle Ciocco Paris
  • Catégorie : International
    • China – China Issues Guidelines on Children’s Cosmetics
    • Australia – TGA publishes updated guidelines for sunscreens
• Catégorie : Santé Publique
  • France – La baisse du remboursement de certains médicaments par la « Sécu », un choc pour toute la chaîne de la santé
  • Europe – New chair of the MHRA
  • Europe – Antimicrobial Resistance : A call to action against the silent pandemic
  • France – La HAS chargée de structurer la posologie des médicaments pour mieux sécuriser les e-prescriptions
  • France – Doliprane, Dafalgan, Ventoline ou Spasfon : l’Assurance-maladie livre son palmarès des médicaments remboursés les plus consommés en France
  • France – De nouveaux membres pour la commission de la transparence (CT) et la commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS)
  • International – WHO announces priority endemic pathogens for urgent vaccine development
  • France – Androcur : une plainte déposée par les victimes du médicament pour mise en danger d’autrui et tromperie aggravée
  • France – Catherine Paugam-Burtz nommée directrice générale de l’ANSM
  • France – L’AIS et la HAS signent une charte de coopération
  • UK – UK to create world-first ‘early warning system’ for pandemics
  • UK – Smoking ban introduced to protect children and most vulnerable
  • Europe – Fostering regulatory collaboration to improve access to mpox medicines
  • Europe – Virus mpox : un premier cas du nouveau variant confirmé en Allemagne
  • International – Egypt is certified malaria-free by WHO
  • France – Questions/Réponses – Vaccination grippe saisonnière et COVID-19
  • France – Le Clusif et l’AFCDP publient un nouveau guide sur le traitement des données de santé
  • USA – FDA issues emergency compounding guidance to address drug shortages due to recent hurricanes
  • France – Doliprane : des politiques de tous bords demandent au gouvernement d’empêcher la cession de la filiale de Sanofi à un fonds américain
  • Europe – Overcoming the COVID-19 pandemic together and building a Health Union
  • France – Projet de loi de financement de la sécurité sociale pour 2025
  • International – Diabète de type 1 : des cellules souches reprogrammées ont permis de « guérir » une patiente
  • France – L’épidémie de Covid-19 connaît un regain, sans « aucun signal inquiétant », selon les experts
  • France – Didier Raoult interdit d’exercer la médecine durant deux ans
  • France – Tramadol et codéine devront être prescrits sur une ordonnance sécurisée dès le 1er décembre
  • France – Pénuries de médicaments : 8 millions d’euros d’amendes pour 11 laboratoires pharmaceutiques
  • International – Covid-19 : une étude précise la présence à Wuhan, en 2019, d’animaux potentiellement vecteurs du SARS-CoV-2
  • International – WHO adds first mpox vaccine to prequalification list
  • France – Moustique-tigre : un « risque assez élevé » d’épidémies en France dans les cinq prochaines années, alerte l’Anses
  • International – WHO issues guideline to curb antibiotic pollution
  • France – Dépakine : Sanofi condamné à indemniser la lanceuse d’alerte Marine Martin après douze ans de procédure
  • France – Covid-19 : une nouvelle publication du professeur Didier Raoult signalée aux autorités de santé
  • Europe – Harnessing AI in medicines regulation: use of large language models (LLMs)
  • UK – Revised recommendations for the prevention of secondary Haemophilus influenzae type b (Hib) disease
  • France – Les autorités sanitaires renforcent la stratégie vaccinale de lutte contre le mpox
  • USA – Un outil numérique de messagerie a augmenté l’arrêt du vapotage chez des adolescents américains
  • UK – MHRA finds evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal and self-injurious thoughts and actions
  • France – Mpox (MPXV) : la HAS actualise ses recommandations vaccinales pour mieux lutter contre la circulation du virus
  • France – Microbiote : Une bactérie intestinale responsable d’une maladie auto-immune
  • USA – FDA warns Walmart, Amazon, and other retailers over unapproved skin peel products
  • USA – FDA dings Kaleo over Instagram post with insufficient risk information
  • France – Nouvelle réglementation européenne sur les substances d’origine humaine (SoHO)
  • USA – Lait pour prématurés : aux Etats-Unis, les laboratoires pharmaceutiques Abbott condamnés à payer 495 millions de dollars
  • France – Budget de la « Sécu » : une préparation tronquée, un cap politique en suspens
  • France – Le gouvernement interdit Sniffy, une poudre énergisante à inhaler par le nez
  • France – La HAS répond au droit d’alerte sur la prise en charge des effets indésirables liés aux fluoroquinolones
  • France – Recrudescence de la coqueluche : la HAS renforce les recommandations vaccinales pour protéger les nouveau-nés et les nourrissons
  • Europe – Ph. Eur. bids adieu to rabbit pyrogen test in its monographs
  • International – Le Covid-19 tue encore environ 1 700 personnes par semaine dans le monde, selon l’OMS
  • Europe – EMA’s safety committee elects new chair
  • France – La HAS propose l’extension du dépistage néonatal à l’amyotrophie spinale
  • France – Les autorités de santé alertent sur la circulation croissante d’opioïdes de synthèse, dont une nouvelle classe particulièrement dangereuse, désormais inscrite sur la liste des stupéfiants
  • France – Un cas autochtone de dengue signalé pour la première fois de l’année en France, dans l’Hérault
  • France – Stratégie vaccinale de prévention des infections par le VRS chez l’adulte âgé de 60 ans et plus
  • Europe – Canada joins Horizon Europe programme
  • France – Doctolib teste un « assistant de consultation » doté d’intelligence artificielle
  • Africa – Variole du singe : une nouvelle souche plus dangereuse apparue en RDC inquiète l’OMS et les chercheurs
  • UK – NICE and NHS England announce plan to enable innovative tech to be adopted quicker
  • UK – New pregnancy prevention measures introduced for topiramate
  • France – Covid-19 : une circulation virale accrue, boostée par le nouveau sous-variant KP.2
  • France – Les pharmaciens vont pouvoir prescrire des antibiotiques sans ordonnance pour des angines et cystites
  • International – La grippe aviaire de type H5N2 fait sa première victime humaine, rapporte l’Organisation mondiale de la santé
  • International – « Il est urgent d’harmoniser les réglementations internationales de biosécurité dans la recherche »
  • International – Le Rwanda se positionne en futur hub régional de la production de vaccins ARN messager
  • France – Label « Prise en charge de la douleur de l’accouchement : analgésie périmédullaire et alternatives médicamenteuses » – Note de cadrage
  • France – Grossesse et VIH : désir d’enfant, soins de la femme enceinte et prévention de la transmission mère-enfant
  • Europe – Annual report highlights progress in science, medicines and health in 2023
  • France – Sécurité sociale : en 2024, le déficit pourrait être supérieur de 6 milliards d’euros aux prévisions
  • UK – Sang contaminé au Royaume-Uni : pourquoi le scandale n’est-il reconnu que maintenant ?
  • France – Le Sénat pose des interdictions à la prise en charge médicale des mineurs transgenres
  • France – Comprendre la polémique autour de « Sniffy », la poudre blanche énergisante à inhaler par le nez
  • France – Christelle Ratignier-Carbonneil quitte la direction de l’Agence nationale de sécurité du médicament
  • International – Study finds link between malaria parasites developing antimalarial drug resistance
  • Europe – Le nombre de cas de coqueluche en forte augmentation en Europe
  • Europe – European medicines network designated as WHO listed authority
  • UK – Pharmacists who illegally supplied more than 55 million doses of controlled drugs sentenced
  • France – Défaut d’impression de quelques pipettes graduées de Doliprane 2,4 % suspension buvable : vérifiez les pipettes dans vos boîtes
  • France – Le Centre de crises sanitaires du ministère chargé de la santé
  • France – Mise à jour des référentiels santé: la Cnil ouvrira une consultation le 16 mai
  • UK – New 5-year plan to combat antimicrobial resistance
  • USA – Le gouvernement américain sur le point de classer le cannabis comme une drogue moins dangereuse
  • Europe – ETF recommends updating COVID-19 vaccines to target new JN.1 variant
  • International – Talc et cancer : Johnson & Johnson prêt à débourser 6,5 milliards de dollars pour clore les poursuites
  • International – Respirateurs Philips défectueux : la marque accepte de payer 1,1 milliard de dollars après des plaintes aux Etats-Unis
  • International – Confidentiality arrangement between the EU and the Republic of Korea
  • International – Choléra : Mayotte se prépare à devoir faire face à une épidémie
  • France – Méningite : la vaccination obligatoire pour les bébés sera élargie à partir du début de 2025
  • Europe – EU Health Data Space: more efficient treatments and life-saving research
  • France – Nestlé contraint de détruire deux millions de bouteilles de Perrier après une contamination bactérienne
  • International – Les vaccins ont permis de sauver 154 millions de vies depuis cinquante ans, selon l’OMS
  • Europe – L’UE ouvre une enquête sur les marchés publics chinois de dispositifs médicaux
  • France – Retrait d’un vaccin antigrippal en raison d’un bras de fer tarifaire entre Sanofi et les autorités sanitaires
  • France – Le moustique tigre : une implantation dans 78 départements en métropole
  • France – « Décennie numérique »: la France fixe l’objectif que « 100% des citoyens de l’UE » aient accès à leur dossier médical électronique en 2030
  • UK – Study reveals how specific nasal cells protect against COVID-19 in paediatric patients
  • France – Scandale du Levothyrox : une nouvelle étude menée en partie par des chercheurs toulousains charge le fabricant Merck
  • International – COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements
  • USA – Court orders Philips to stop CPAP, BiPAP, ventilator production
  • France – Tramadol : moins de comprimés dans les boîtes pour un meilleur usage
  • France – Cannabis : « Le moment est venu de débattre de la meilleure manière de réguler le marché dans un cadre légal »
  • France – Défaut du code-barre datamatrix sur certaines boîtes de Dépakine 500 mg chrono
  • France – Interdiction au 2 avril 2024 de la publicité auprès du grand public pour l’ibuprofène 400 mg
  • France – Infections invasives à méningocoques : des recommandations vaccinales actualisées
  • International – Prévention des pandémies : les pays membres de l’OMS n’ont pas réussi à conclure un accord international
  • UK – The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect
  • France – Cancer du sein : une piste pour bloquer la formation de métastases
  • France – Recommandations relatives aux lieux et conditions d’environnement pour la réalisation d’une téléconsultation ou d’un télésoin
  • Europe – Le Parlement trouve un accord sur l’interdiction des cigarettes électroniques jetables puffs
  • Japan – La propagation rapide d’une infection bactérienne grave inquiète le Japon
  • France – Deux nominations à la HAS
  • UK – Disgraced company director convicted of falsifying medicine quality data
  • UK – Researchers reveal COVID-19 could have small impacts on cognition and memory
  • USA – Aux Etats-Unis, les républicains embarrassés par la décision de l’Alabama de considérer les embryons congelés comme des enfants
  • UK – First UK patients receive experimental mRNA therapy for cancer in global trial
  • Brazil – Le Brésil menacé par une épidémie de dengue sans précédent
  • France – Expérimentation par la HAS de la méthode de labellisation d’indicateurs conçus par des organismes externes pour l’amélioration de la qualité et de la sécurité des soins à partir de 2024
  • France – Interdiction de la publicité auprès du grand public pour l’ibuprofène 400 mg
  • France – Papillomavirus : l’intérêt de vacciner jusqu’à 26 ans pour prévenir le cancer du col de l’utérus débattu
  • France – Vitiligo : un premier traitement disponible en France
  • France – Nestlé reconnaît avoir eu recours à des traitements interdits sur des eaux minérales pour maintenir leur « sécurité alimentaire »
  • France – Stratégie française en santé mondiale (2023-2027)
  • USA – Johnson & Johnson agrees $700m settlement to resolve talcum powder investigations
  • France – La HAS a adopté le référentiel d’agrément des sociétés de téléconsultation
  • France – Innovation médicale : Franck Zal et son ver marin des plages bretonnes remportent le prix Galien
  • France – Lionel Collet nomme Jean Lessi à la direction générale de la HAS
  • USA – FDA considers issuing more final guidances without comment period
  • USA – GOP lawmakers prod FDA over internal scientific disputes resolution process
  • France – Lionel Collet nomme Jean Lessi à la direction générale de la HAS
  • France – Procès du Mediator : Servier condamné en appel à rembourser plus de 415 millions aux organismes de Sécurité sociale
  • France – Progestatifs et risque de méningiome : recommandations pour limiter ce risque
  • France – « La PMA est une médecine hasardeuse en l’absence de diagnostic préimplantatoire »
  • International – Variole du singe : l’OMS craint que l’épidémie ne se propage dans le monde depuis la RDC
  • UK – Physical activity could reduce breast cancer risk in women before menopause
  • Europe – La Commission européenne et l’OMS souhaitent développer l’interopérabilité des données de santé
  • France – Numérique en santé: l’essentiel du PLFSS pour 2024
  • USA – FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs
  • Europe – EU medicines agencies reflect on lessons learned from COVID-19
  • France – Respirateurs : nouveaux risques d’interférence entre des masques et des implants médicaux
  • France – L’Assemblée nationale vote l’interdiction des cigarettes électroniques jetables
  • Europe – Traitements anti-rhume : le comité du risque de l’Agence européenne des médicaments élargit les mesures de précaution
  • France – Les intoxications avec les sachets de nicotine ou de tabac en hausse, surtout chez les jeunes, alerte l’Anses
  • France – Durées de conservation dans le secteur social et médico-social : la CNIL publie un référentiel et une fiche pratique
  • France – Espaces de télémédecine dans les gares: Aurélien Rousseau appelle à ne « pas mélanger soin et consommation »
  • France – Antibiorésistance : une nouvelle stratégie interministérielle
  • France – L’ordre des médecins exprime « sa profonde inquiétude » sur le projet d’installation d’espaces de télémédecine dans les gares SNCF
  • France – Lionel Collet propose de nommer Jean Lessi à la direction générale de la HAS
  • France – PLFSS 2024: recadrage de la durée des arrêts de travail et des prescriptions par téléconsultation
  • Europe – JCVI advises on gonorrhea and mpox vaccinations
  • USA – FDA Approves New Medication for Chronic Weight Management
  • France – L’Académie de médecine redéfinit l’accès à ses séances en direct via YouTube
  • France – Ordre des pharmaciens contre Livmed’s: le tribunal judiciaire de Paris sursoit à statuer
  • UK – AI twice as accurate as a biopsy when grading severity of sarcomas
  • UK – AI tools to speed up lung cancer diagnosis in NHS hospitals
  • International – Interpol, global regulators seize $7 million worth of counterfeit drugs
  • International – WHO releases 13 interventions to help address antimicrobial resistance
  • France – En cas de rhume, évitez les médicaments vasoconstricteurs par voie orale !
  • France – Vers des forfaits majorés pour la télésurveillance des diabétiques et insuffisants cardiaques
  • France – Diabète : des taxis moléculaires pour lutter contre l’insulinorésistance
  • France – Les cancers du larynx et de l’ovaire provoqués par l’amiante reconnus maladies professionnelles
  • Spain – Spain Creates AI Regulator to Enforce the AI Act
  • France – La France lance sa nouvelle stratégie en santé mondiale (2023-2027)
  • France – Dépakine. « Un foutage de gueule immense » : le combat d’une mère, lanceuse d’alerte, pour faire indemniser ses enfants handicapés
  • USA – Reimbursement, AI top list of priorities for new digital health lobbying group
  • France – Papillomavirus : pourquoi la vaccination des garçons est-elle aussi essentielle ?
  • India – India finds two more toxic syrups months after poisoning deaths
  • International – WHO recommends second malaria vaccine for children
  • International – Choléra : le nombre de cas rapportés à l’OMS a doublé entre 2021 et 2022
  • International – Nobel Prize in Medicine awarded to pair of scientists behind mRNA COVID-19 vaccines
  • International – Un deuxième vaccin contre le paludisme jugé « sûr et efficace » par l’OMS
  • France – Budget PLFSS 2024 : des mesures au service de la santé et des solidarités collectives
  • France – Bronchiolite : Succès de la campagne d’immunisation et priorisation vers les nourrissons
  • International – World leaders commit to new targets to end TB
  • Europe – Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies
  • USA – US CDC recommends updated COVID-19 vaccines for autumn/winter season
  • France – Vaccination contre les papillomavirus humains : Gabriel Attal, ministre de l’Education nationale et de la Jeunesse, et Aurélien Rousseau, ministre de la Santé et de la Prévention, lancent une campagne d’information nationale
  • UK – New UK study suggests brain fog after COVID-19 is linked to blood clots
  • France – Kétamine : l’usage récréatif a pris de l’ampleur en France, et avec lui l’apparition de complications graves
  • France – Les cigarettes électroniques jetables « puffs » seront bientôt interdites, annonce Elisabeth Borne
  • France – Levothyrox : l’ancienne formule distribuée en France jusqu’en 2025
  • France – Évaluation du programme national de dépistage de la surdité permanente néonatale – Note de cadrage
  • UK – NHS rolls out world-first programme to transform diabetes care for under 40s
  • International – Le papillomavirus humain touche près d’un tiers des hommes dans le monde, selon une étude
  • France – Actualisation des recommandations et obligations vaccinales des professionnels
  • UK – NHS to roll out flu vaccines for children from September
  • Europe – EMA’S Response to the COVID-19 Pandemic
  • France – La prise de Dépakine chez le père pourrait présenter un risque pour l’enfant, prévient l’ANSM
  • USA – GSK files lawsuit against Pfizer over RSV vaccine patent infringement
  • International – Johnson & Johnson’s attempt to resolve talcum powder lawsuits fails a second time
  • France – Aurélien Rousseau remplace François Braun au ministère de la santé et de la prévention
  • France – Covid-19: clap de fin pour Sidep et TousAntiCovid
  • France – Difficultés d’approvisionnement en corticoïdes (prednisone et prednisolone) : l’ANSM publie une recommandation pour les pharmaciens
  • International – WHO says toxic syrup risk ‘ongoing’, more countries hit
  • France – Respirateurs Philips défectueux : plus de 200 personnes portent plainte, dont trois pour homicides involontaires
  • France – Tous les ans, 8 000 cancers induits par les infections à papillomavirus humain pourraient être évités
  • France – La HAS se prononce sur l’intérêt médical des TROD grippe/Covid-19/VRS
  • France – Dépistage et diagnostic dans le cadre de la Covid -19
  • France – Les biosimilaires, vivier d’économies pour la Sécurité sociale
  • France – Informatique: un décret « ROR » attendu pour « la fin du semestre » (ministère)
  • France – A la fin du procès en appel du Mediator, Servier clame une dernière fois sa « bonne foi »
  • France – L’ANSM alerte sur le bon usage des médicaments
  • France – Données de santé et consentement: la Cnil inflige une amende de 380.000 € au site Doctissimo
  • France – Étude de Didier Raoult sur l’hydroxychloroquine : le gendarme du médicament va saisir la justice
  • France – Mediator : l’accusation réclame la « confiscation du bénéfice » lié au médicament, soit jusqu’à 182 millions d’euros
  • 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

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• Category Formations IFEP