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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
- UK – ICR calls for further discussions following NICE’s rejection of breast cancer drug
- Europe – IA: la Commission européenne renforce l’exigence de garantie humaine
- UK – NICE recommends Janssen’s treatment for active psoriatic arthritis
- Europe – Commission seeks 5-year extension MDR/IVDR delegated acts powers
- Catégorie : Médicaments
- 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
- Europe – DARWIN EU® continues expanding its capacity to deliver real-world data studies
- Switzerland – Nouvelles autorisations de médicaments complémentaires et de phytomédicaments
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- USA – FDA finalizes guidance on REMS format and content
- USA – FDA’s drug approvals in 2022
- 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?
- USA – FDA issues pharmacy compounding guidance due to amoxicillin shortage
- USA – FDA finalizes enforcement policy for FMT treatments
- UK – NHS fast tracks life-extending prostate cancer drug to patients
- UK – Bristol Myers Squibb’s Opdivo recommended by NICE for rare gastroesophageal cancers
- USA – mRNA technology for universal flu vaccine shows early promise in US study
- Europe – AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment
- Europe – DARWIN EU® welcomes first data partners
- USA – FDA’s top 10 tips to transition your COVID-19 products
- USA – FDA releases guidance on compounding beta-lactam products in shortage
- USA – FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
- USA – Industry asks FDA to align quantitative labeling guidance with other regulators
- Europe – EMA offers insights on when biologics qualify as new active substances
- Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation
- USA – Most FDA warning letters this year from onsite inspections
- Europe – Best practices to fight antimicrobial resistance
- UK – NICE recommends Sobi’s Doptelet to treat thrombocytopenia
- UK – Kidney Cancer UK receives commission from NICE
- USA – FDA approves first drug to delay onset of type 1 diabetes
- UK – NICE recommends Pfizer’s Paxlovid on NHS
- UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
- USA – FDA relaxes EUA advertising limitation for some COVID drugs
- UK – Research provides hope for patients with neurodegenerative disease
- UK – NICE publishes draft guidance recommending three COVID-19 treatments
- USA – FDA Adds/Revises Product-Specific Guidances
- USA – Stakeholders ask FDA to harmonize adverse events terms with standards orgs
- Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity
- UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
- USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
- USA – FDA takes first step to allow low-dose OTC naloxone on market
- USA – Biosimilar facilities usually get onsite inspections
- France – Covid-19 : intégration du vaccin bivalent Spikevax® (BA.4-BA.5) dans la stratégie vaccinale
- Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
- Europe – New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
- Europe – EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
- Europe – EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
- UK – Ipsen’s cabozantinib receives NICE approval for advanced hepatocellular carcinoma
- USA – FDA drafts guidance on ‘sameness’ evaluations for generic drugs
- USA – FDA Says Face-to-Face Meetings Include Virtual
- UK – Merck’s Keytruda receives NICE recommendation as breast cancer treatment option
- UK – MHRA updates biosimilar guidance to allow interchangeability between products
- Europe – Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs
- USA – FDA finalizes umbrella trial guidance for cell and gene therapies
- UK – Digital cognitive behaviour therapies recommended by NICE across the NHS
- Europe – Regulatory update – EMA encourages companies to submit type I variations for 2022 by end of November
- USA – FDA updates guidance on expanded access for investigational drugs under IND
- USA – FDA announces CMC review pilot for drugs with expedited development
- Europe – EMA grants AZ’s Vaxzevria COVID-19 vaccine full marketing authorisation
- USA – FDA draft guidance aims to ensure accurate measurements of pediatric growth
- USA – FDA releases draft guidance to spur development of CDI drugs
- Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
- Europe – EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
- USA – Accès précoce et compassionnel: mise en oeuvre de l’authentification unique pour le recueil de données
- USA – FDA releases new draft guidances on topical generic drugs
- USA – FDA finalizes neurodegenerative disease gene therapy guidance
- USA – FDA issues 80 guidances for topical products
- USA – FDA finalizes multiple endpoints guidance
- USA – Generic manufacturers call for changes to list of major deficiencies
- USA – FDA starts PDUFA VII programs for real-world evidence, innovative trial designs
- Europe – EMA recommends approval of second adapted Spikevax vaccine
- Europe – EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
- UK – Grifols’ Tavlesse receives NICE recommendation
- USA – Pharma industry making some headway in DSCSA implementation
- USA – Comparability protocols: Final guidance incorporates ICH Q12, allows for API supplier changes
- USA – FDA issues final guidance on AML drug development, two oncology draft guidances
- USA – FDA addresses alternative inspection tools, expectations for nitrosamine assessments in updated CPGs
- Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde contre des risques graves rénaux et gastro-intestinaux
- USA – FDA releases discussion paper on distributed and point-of-care manufacturing
- Europe – New vaccine to protect people in the EU and worldwide against dengue
- Europe – First therapy to treat transplant patients with post-transplant lymphoproliferative disease
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
- USA – FDA expands bivalent COVID boosters to kids as young as 5
- Europe – Data Quality Framework for EU medicines regulation
- USA – Experts call for federal incentives to promote clinical trial diversity
- Europe – High-quality data to empower data-driven medicines regulation in the European Union
- France – Le logiciel officinal Pharmony One obtient l’agrément Sesam-Vitale
- USA – Sentinel System expands capacity, data linkages, report indicates
- Europe – EMA Management Board: highlights of October 2022 meeting
- UK – Bristol Myers Squibb’s active ulcerative colitis treatment bags NICE recommendation
- USA – FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III
- France – Certification des logiciels d’aide à la dispensation (LAD) de pharmacie à usage intérieur (PUI)
- USA – FDA issues guidances on facility readiness and early DMF assessments under GDUFA III
- USA – FDA offers details on PDUFA VII STAR review pilot
- USA – FDA warns that emerging Omicron subvariant could make Evusheld obsolete
- France – Avis relatif à la couverture des besoins de la population générale en vitamine D et en fer
- France – L’ANSM publie les nouvelles règles des bonnes pratiques de préparation
- France – Virus de la variole du singe : recommandations pour sécuriser les dons de selles dans le cadre de la transplantation de microbiote fécal (TMF)
- USA – OIG raises concerns about accelerated approval pathway
- UK – European Commission Decision Reliance Procedure (EC DRP) extension
- USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
- Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
- Europe – EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
- USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies
- USA – FDA seek to harmonize human subject protections with revised Common Rule
- USA – New FDA guidance offers ethical roadmap for including children in clinical trials
- USA – Califf: FDA committed to boosting complex generic drug development
- USA – Prenatal cannabis exposure associated with mental disorders in children that persist into early adolescence
- UK – MSD’s pembrolizumab therapy gets NICE approval
- International – Genetically modified herpes combats advanced cancers
- Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants
- Europe – Biosimilar medicines can be interchanged
- Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection
- Europe – EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
- USA – FDA issues final rule on ‘right to try’ reporting requirements
- USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
- India – Indian Pharmacopoeia joins global discussion group pilot
- USA – FDA issues guidance documents on labeling drug identity, constituents
- USA – FDA finalizes guidance on submitting RWD/RWE in application cover letters
- Europe – Annex 1 implementation strategies: Experts say manufacturers must grapple with PUPSIT
- Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
- UK – MHRA launches new conflicts of interest code of practice for independent advisors
- USA – Groups weigh in on FDA’s licensing rules for 3PLs and distributors
- USA – Industry experts tout potential for master protocols in pediatric clinical trials
- USA – FDA issues emergency guidance to spur development of monkeypox tests
- USA – FDA drafts guidance on pediatric clinical pharmacology studies
- Europe – COVID-19 vaccines safety update
- UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment
- Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for control of bacterial endotoxins in its water monographs
- Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products
- Europe – New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European Pharmacopoeia
- Europe – 11th edition of the European Pharmacopoeia now available in print
- Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
- UK – Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE
- France – HAS : Covid-19 – un avis global sur les vaccins bivalents mi-septembre
- USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
- Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
- USA – House report finds Trump officials sought to influence FDA during COVID pandemic
- USA – FDA allows sponsors to spread out costs in revised IND charging guidance
- USA – FDA approves durvalumab for locally advanced or metastatic biliary tract cancer
- Europe – New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone
- Europe – Review of pholcodine medicines started
- Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing potential
- Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
- USA – FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines
- Europe – EU issues long-awaited GMP Annex 1 revision
- Europe – Patient registries: EMA officials highlight opportunities in orphan drug development
- Europe – EMA accepts application for leukaemia drug from Otsuka and Astex
- USA – European, US guidance differs on API nitrosamines
- Asia – 3D-printed drug advancing to clinical trials in SE Asia
- USA – Patients with incurable cancer should be included in trials for new therapies
- USA – FDA issues final guidance on ANDA CRL, Orange Book
- USA – FDA final guidance targets neonatal pharmacology studies
- Europe – EMA reviewing data on sabizabulin for COVID-19
- USA – FDA guidance focuses on Real-Time Oncology Review program
- USA – FDA describes plans to expand remote regulatory assessments
- Europe – EMA recommends restricting use of cancer medicine Rubraca
- Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
- USA – FDA offers new guidance on therapeutic equivalence evaluations
- USA – FDA guidance targets dose banding information in drug labels
- Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
- Europe – Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
- Europe – ICH Guideline M12 on drug interaction studies
- UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark MHRA reclassification
- USA – Industry asks FDA to expand scope of product quality assessment guidance
- UK – NICE recommends Rhythm Pharmaceuticals’ Imcivree for severe obesity and hyperphagia
- USA – Legislation could catalyze EU pharma industry innovation
- Europe – EC authorisation granted to kidney disease treatment Kinpeygo
- Europe – EMA validates application for Byondis’ trastuzumab duocarmazine
- UK – Bristol Myers Squibb’s Opdivo recommended by NICE for malignant pleural mesothelioma patients
- UK – NICE recommends Novartis’ Piqray in combination with Faslodex for advanced breast cancer patients
- Europe – EMA re-elected as chair of ICMRA from October 2022
- USA – Guidance : Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products
- USA – HHS issues guidance on legally prescribed drugs for abortion
- Europe – EMA launches pilot project on analysis of raw data from clinical trials
- Europe – ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
- Europe – Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
- Europe – Further measures to identify and address medicine shortages during public health emergencies adopted
- Uk – NICE recommend’s use of Leo Pharma’s Adtralza
- Italy – The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
- Europe – Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
- USA – FDA offers guidance on fit-for-purpose clinical outcome assessments
- France – Rapport d’activité 2021 de la HAS
- Europe – Global regulators agree on key principles on adapting vaccines to tackle virus variants
- UK – NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia
- Europe – EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate
- UK – NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis
- France – Topiramate : risque de troubles neurodéveloppementaux chez les enfants exposés in utero et rappel des règles d’utilisation chez les femmes
- Europe – Possible use of the vaccine Jynneos against infection by monkeypox virus
- Europe – Monkeypox: EMA starts review for Imvanex
- USA – FDA releases 5-year action plan to combat neurodegenerative diseases
- France – Accès précoce et compassionnel: les deux nouveaux référentiels de la Cnil attendus en septembre
- USA – FDA explains when it will rescind breakthrough designations
- Europe – First gene therapy to treat severe haemophilia A
- Europe – EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
- Europe – EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
- UK – NICE opts to reject Acorda’s MS drug Fampyra
- USA – Draft guidance outlines FDA’s testing requirements for tissue containment systems
- USA – Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver
- USA – FDA to form task force, public-private partnership on rare neurodegenerative diseases
- France – Covid-19 : l’Agence européenne des médicaments autorise la mise sur le marché du vaccin de Valneva
- France – Médicament: ouverture d’une plateforme de dépôt de dossiers auprès du CEPS
- France – HAS : Monkeypox : la stratégie vaccinale réactive précisée pour les primo-vaccinés et les enfants
- Europe – Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
- Europe – EMA Management Board: highlights of June 2022 meeting
- USA – FDA authorizes Pfizer, Moderna vaccines for youngest children
- Europe – Start of rolling review for adapted Spikevax COVID-19 vaccine
- UK – NICE recommends Eli Lilly’s breast cancer therapy
- UK – Genedrive genetic variant test for infants evaluated by NICE
- UK – MHRA joins international partnerships to set global standards for medicines and medical devices regulation
- Europe – Start of rolling review for adapted Comirnaty COVID-19 vaccine
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022
- Europe – EMA recommends withdrawal of marketing authorisation for amfepramone medicines
- France – Intérêt du logiciel doté d’IA « PharmaClass » pour aider le pharmacien clinicien à sécuriser la prise en charge médicamenteuse
- Europe – EMA : Complex clinical trials – Questions and answers
- Europe – EMA publishes annual report 2021
- UK – NICE recommends Vazkepa for patients at risk of stroke and heart attacks in England and Wales
- USA – Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests
- Europe – EMA adopts first list of critical medicines for COVID-19
- USA – Cavazzoni: Pandemic-era tools, learnings are here to stay
- India – Indian pharma to focus on quality to remain a world leader
- Europe – EU regulators offer new guidance on complex clinical trials
- USA – FDA withdraws cancer drug approval after finding possible higher death rates
- UK – NICE recommends UCB’s Fintepla for Dravet syndrome
- UK – NICE approves Merck’s Keytruda for adult patients with rare triple negative breast cancer
- USA – FDA officials reflect on quality maturity model, quality metrics
- UK – NICE recommends Roche’s faricimab (Vabysmo) as a treatment option for two leading forms of sight loss
- Europe – Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
- Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
- UK – NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC
- USA – Medtech groups want more time to implement FDA’s QMSR rule
- USA – FDA issues Q&A on importation of prescription drugs from Canada
- France – Lyon: ouverture d’un centre spécialisé dans la prise en charge des addictions aux médicaments
- USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
- Europe – EMA medical terms simplifier
- International – Pfizer/BioNTech vaccine effective against Omicron in children five and under
- Europe – Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements.
- Europe – Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
- Europe – EMA guidance supports development of new antibiotics
- USA – Les Etats-Unis se dirigent vers la vaccination des cas contacts contre la variole du singe
- UK – G7 health ministers unite to protect world from another pandemic
- USA – FDA asks manufacturers to develop risk management plans to avert shortages
- Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
- Europe – Synchron Research Service: suspension of medicines over flawed studies
- Europe – First therapy to treat rare genetic nervous system disorder AADC deficiency
- Europe – First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes)
- Europe – EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine
- UK – NICE recommends app-based treatment for insomnia over sleeping pills
- Canada – Update : Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format
- USA – FDA updates guidance on evaluating out-of-specification results for drugs
- UK – MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment
- UK – COVID-19 vaccine study focuses on young and immunosuppressed
- UK – NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer
- USA – FDA works to advance real-world data collection in pregnancy and lactation
- Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe
- UK – NICE draft final guidance for Gedeon Richter UK’s new uterine fibroids treatment
- USA – FDA guidance explains benefit-risk approach for quality assessments
- USA – FDA launches program to speed up rare disease drug development
- Europe – COVID-19 vaccines safety update
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
- Europe – Rules of procedure of the Emergency Task Force (ETF)
- Europe – EMA updates annexes on procedures for running GCP inspections
- USA – FDA offers insight into product quality assessment principles
- USA – FDA sheds light on conducting human radiolabeled mass balance studies
- Europe – EMA starts review of cancer medicine Rubraca
- International – Pherecydes Pharma : autorisation d’un 1er traitement compassionnel avec ses phages à l’international
- France – Covid-19 : la HAS précise le cadre d’utilisation de Xevudy®
- USA – FDA officials: ‘New normal’ may include annual COVID vaccination
- Europe – Nouvelles règles européennes sur le devoir de vigilance
- USA – FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease
- Uk – NICE recommend exercise over painkillers for arthritis pain
- UK – Scientists to trial world-first long-acting injection for high blood pressure
- USA – FDA finalizes electronic postmarketing safety reporting guidance
- USA – FDA finalizes guidance for drugs and biologics containing nanomaterials
- Catégorie : International
- 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
- International – Biosimilars, are they comparable to their reference counterparts?
- International – WHO launches R&D efforts to identify pathogens that could cause future pandemics
- International – Modular plug-and-produce facilities for cell therapies
- International – ICH M11 guideline, clinical study protocol template and technical specifications
- International – ICH : Clinical Electronic Structured Harmonised Protocol (CESHARP) M11
- International – ICH releases M11 guideline proposing harmonized template for trial protocols
- International – ICH advances guidelines on selective reporting of safety data, viral safety
- International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
- International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin (Step 2b)
- International – ICH M12: Pharma industry wants clarity on rifampin dosing, more information on biomarkers
- International – ICH Q14: Pharma groups want clarity on benefits of enhanced approach
- International – WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out
- International – Pfizer doses first patients with mRNA-based influenza vaccine
- International – Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2)
- International – ICH signs off on carcinogenicity testing addendum
- International – Novartis confirms death of 2 children after gene therapy
- International – ICH M10 on bioanalytical method validation
- International – Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines
- International – Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine
- International – Moderna announces trial results for new COVID-19 booster vaccine candidate
- International – ICH details milestones reached on guidelines after Athens meeting
- International – FDA, EMA officials discuss impediments to cell and gene therapies
- International – International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines
- International – WHO recommends Veklury for high-risk patients
- International – ICH plans model-informed drug development guideline in 3-4 years
- International – Mechanical, material stresses affect drug quality
- Catégorie : France
- France – La HAS actualise la stratégie de vaccination contre le zona
- France – Cannabis médical : point d’étape sur la dernière année de l’expérimentation et l’arrivée de médicaments à base de cannabis
- 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
- France – Médicaments à base de miansérine : rappel du bon usage et des risques d’effets indésirables graves notamment chez les patients âgés
- France – Vaccination contre le Covid-19 et maternité
- France – Traitement de l’acné sévère : mieux faire connaître les risques associés à l’isotrétinoïne orale
- 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
- France – Clomid (citrate de clomifène) : le traitement doit être arrêté en cas d’altération de la vision
- France – Relocalisations de médicaments essentiels – Dossier de presse le 13/06/2023
- France – L’ANSM classe l’hexahydrocannabinol (HHC) et deux de ses dérivés sur la liste des stupéfiants
- 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
- 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
- France – Sérialisation: vers une pénalité trimestrielle et reconductible de 2.000€ pour les officinaux
- France – « Contre la résistance aux antibiotiques, la recherche et la production publiques de médicaments s’imposent »
- International – ICH E11A: Pharma groups want more information on data extrapolation, pediatric biomarkers
- France – Monkeypox : la HAS complète ses recommandations sur la vaccination
- France – La HAS publie le référentiel de certification des logiciels d’aide à la dispensation de PUI
- France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de vaccination pour l’automne
- France – ANSM : Pholcodine : Suspension des autorisations de mise sur le marché et retrait de toutes les boîtes de sirop contenant de la pholcodine en raison d’un risque d’allergie croisée avec les curares
- France – HAS : Agrément des Bases de données sur les Médicaments
- France – La HAS recommande la vaccination des nourrissons contre les infections à rotavirus
- France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs
- France – Covid-19 : la HAS élargit l’autorisation d’accès précoce accordée à Evusheld®
- France – Covid-19 : la HAS se prononce en faveur du remboursement du Paxlovid®
- Catégorie : Europe
- Catégorie : Amériques
- Catégorie : Asie-Pacifique
- Catégorie : Découverte
- Catégorie : DM-DIV
- 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 – 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
- 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
- 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
- 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 – 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 – 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’
- International – Medical devices 2030 : Making a power play to avoid the commodity trap
- Europe – Artificial Intelligence Act : un nouveau règlement européen à suivre de près
- UK – Borderline products: how to tell if your product is a medical device and which risk class applies
- UK – Register medical devices to place on the market
- USA – Theranos : onze ans de prison contre Elizabeth Holmes, patronne déchue, condamnée pour fraude
- Taiwan – Taiwan’s MOHW issues draft revision of UDI requirements; draft amendment of the charge standards of administrative fees for medical devices
- Europe – Accord avec le Royaume-Uni relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité
- USA – FDA rules on definitions of device; issues revised form for reporting adverse events
- Malaysia – MDA publishes draft guidance on notification of custom-made medical devices
- Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)
- USA – Industry seeks clarity, ICH Q9 alignment in FDA’s device production software guidance
- USA – Quinze ans de prison requis contre Elizabeth Holmes, fondatrice de Theranos
- Europe – Nanoparticle-based drug delivery systems
- USA – Action needed on FDA regulation of AI-based medical devices
- USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
- USA – FDA updates guidance on identifying and responding to deficiencies
- Europe – Notified bodies survey on certifications and applications
- UK – New device launched for diagnosing prostate cancer
- Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- USA – FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard
- USA – FDA proposes updates to Breakthrough Devices Program guidance
- UK – Implementation of the future regulation of medical devices and extension of standstill period
- USA – FDA issues road map to medical device regulatory guidance topics list for 2023
- Europe – COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
- USA – FDA proposes breakthrough status for devices that address health disparities
- USA – FDA issues roadmap to medical device regulatory guidance topics list for 2023
- USA – FDA launches TAP Pilot to speed access to safe and innovative medical devices
- Europe – 34ème Organisme Notifié
- USA – FDA device center guidance priority lists targets COVID, digital health
- UK – Guidance : Software and AI as a Medical Device Change Programme
- Australia – TGA set to accept medical device assessments from Singapore’s HSA
- USA – FDA finalizes which clinical decision software functions it regulates
- Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems
- USA – FDA will begin accepting breakthrough devices for TAP pilot in 2023
- USA – US FDA sets some steep increases for 2023 medical device user fees
- UK – MHRA and NICE awarded £1.8m to explore regulation of digital mental health tools
- USA – FDA finalizes guidances on device post-approval studies, postmarket surveillance
- Europe – Cyber Security
- Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745
- Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
- Europe – « Le risque d’une pénurie de dispositifs médicaux fait craindre une nouvelle crise sanitaire »
- USA – Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry
- USA – FDA updates guidances to reflect new MDUFA goals
- South Korea – South Korea rules on emergency production and distribution of medical products
- USA – FDA acknowledges shortcomings of Pre-Cert pilot in report
- USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
- Europe – Notified bodies’ paper on the application of hybrid audits to quality management system assessments under MDR/IVDR
- UK – MHRA appoints first new UK Approved Body to certify medical devices since Brexit
- FDA seek to harmonize human subject protections with revised Common Rule
- Singapore – HSA to commence Phase I implementation of UDI labeling in November 2022
- USA – FDA wants COVID test developers to shift from EUAs to traditional premarket pathways
- USA – New FDA guidance offers ethical roadmap for including children in clinical trials
- China – Un robot miniature biodégradable pour l’administration ciblée de médicaments
- UK – UK regulator MHRA to raise medical device registration and other fees by 10% or more
- Spain – Des applis mobiles pour prédire le risque d’exacerbations de BPCO et détecter le Covid-19 grâce à la voix
- France – Comment la médecine in silico peut accélérer l’innovation en matière de DM
- Europe – MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
- Brazil – ANVISA announces major medical device registration updates
- USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
- USA – FDA drafts guidance on device production and quality system software assurance
- Europe – New European Manual on Borderline and Classification for medical devices and IVDs issued
- USA – Patient preference information: Researchers offer insights on medical device clinical trial design
- Australia – Update: Medical device UDI implementation, Essential Principles guidance
- UK – Medical devices: UK approved bodies
- Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs
- South Korea – Updates: Innovative device designations, IVD Act enforcement
- India – Indian regulators add to list of medical device testing laboratories
- Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) (deuxième avis)
- Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) (première avis)
- USA – FDA finalizes rule for over-the-counter hearing aid devices
- China – Update: Class I medical device filing rules, UDI standards
- USA – FDA: Nearly 700 breakthrough medical device designations since 2015
- South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
- China – Chinese regulators recommend clinical evaluation paths for certain medical devices
- USA – FDA eases UDI compliance requirements for some low-risk medical devices
- South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
- Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR
- Japan – Japan updates guidance on QMS Conformity Survey applications
- Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)
- Singapore – Singapore adds HIBCC to list of UDI issuing agents
- Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey
- India – India issues new draft IVD rules and updated classifications for rehab devices
- Australia – Australia updates guidance on implantable medical devices, required six-monthly report
- UK – E-cigarettes: regulations for consumer products
- China – NMPA rules on medical device naming, QMS inspections and industry standards
- Italy – The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
- Europe – Commission publishes implementing regulation on specifications for class D diagnostics
- UK – What will the UK MHRA consultation bring in terms of medical device and IVD regulations?
- Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private health insurance rules for prostheses
- UK – UK to strengthen regulation of medical devices to protect patients
- USA – FDA finalizes guidance on machine learning for medical devices
- France – Une appli mobile pour accompagner les soignants dans la prise en charge des plaies chroniques et/ou complexes
- Europe – Questions and Answers on Certificates of Free Sale and Article 60 of Regulation (EU) 2017/745 on medical devices (MDR)
- South Korea – South Korea updates regulations on medical device codes and classification
- USA – FDA takes a step forward for machine learning with quantitative imaging guidance
- Japan – Japan’s medical device regulators update PMD Act and the online submissions process
- USA – La FDA planche sur des directives relatives à la sécurité des objets connectés de santé
- China – Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific guidelines and technical review points
- Europe – MDCG 2022-11 MDCG Position Paper Notice to manufacturers to ensure timely compliance with MDR requirements
- USA – US FDA withdraws COVID-era guidance for medical device and IVD market approval processes
- Europe – EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation
- Europe – Exercer la fonction de PCVRR : où en sommes-nous aujourd’hui ?
- USA – FDA considers pilot for lower radiation levels for device sterilization
- Europe – New Swiss IVD regulations come into force as EU mutual recognition agreement expires
- Australia – Process chart: Australia TGA regulatory approval for medical devices
- India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses
- USA – FDA adds transition period to electromagnetic compatibility final guidance
- USA – Pre-submission requests for IVDs to be accepted by FDA
- Europe – MDR/IVDR: Commission seeks comment on revisions to standardization request
- Switzerland – Switzerland joins EU in bringing in new IVD requirements to improve patient safety
- Europe – New guidance from European MDCG ahead of date of application
- Europe – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials
- Australia – Update: TGA defines which digital mental health software it regulates
- Europe – IVDR implementation day overshadowed by lack of notified bodies, risks to patients
- Europe – SSCP expert lists common mistakes device manufacturers make
- Europe – MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- Brazil – ANVISA extends Brazilian Good Manufacturing Practice requirements to more medical device manufacturers
- Europe – MDCG 2022-9 Summary of safety and performance Template
- Europe – MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
- Europe – Uniformiser le processus d’enregistrement des DM à l’échelle de la planète
- Europe – IVDR Watch: European regulators add ISO 14971 to harmonized standards list
- Europe – TUV NORD Polska New Notified Body Designated Under MDR
- Europe – UDEM Adriatic d.o.o. New Notified Body Designated Under MDR
- Europe – MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- UK – What do companies supplying IVDs to the UK market need to know about the IVDR?
- USA – FDA asks manufacturers to develop risk management plans to avert shortages
- Brazil – Brazil’s ANVISA repeals medical device regulations related to the coronavirus pandemic
- Europe – Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
- USA – FDA moves forward with Voluntary Improvement Program to bolster medical device quality
- Europe – IVDR: Commission adds risk management standard to harmonized standards list
- Singapore – Singapore issues new guidance for software as a medical device
- USA – Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device
- Europe – Machine Learning-enabled Medical Devices: Key Terms and Definitions
- Europe – IMDRF: Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form
- Europe – Compliance for medical device makers in the EU and Turkey just got easier
- India – India’s DCGI adds more medical device testing laboratories
- Europe – MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
- USA – FDA drafts guidance on medical device voluntary improvement program
- USA – First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing
- Europe – 3EC International becomes seventh Notified Body designated under EU IVDR
- Europe – MDCG 2022 – 5 : Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
- Australia – TGA publishes latest medical device application processing times
- Catégorie : International
- 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
- International – Enfin une norme internationale sur le dosage des EEB spécifique aux DM !
- Israel – New study use musical tests for early detection of cognitive decline
- International – MDSAP policy for remote quality system audits to expire in September 2022
- South Africa – South African regulators issue guidance for medical device imports, advertising
- Saudi Arabia – Saudi FDA postpones Unique Device Identification compliance deadlines
- International – Des valves cardiaques imprimées en 3D
- International – IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback
- Catégorie : France
- 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
- France – Sécurité: la base de données médicales Claude Bernard décroche la certification ISO 13485
- France – Respirateurs Philips défectueux : un problème connu dès 2016 ?
- France – Alzheimer: intérêt d’un algorithme d’apprentissage profond appliqué à la rétinographie
- France – La Société française de dermatologie appelle les autorités à réglementer l’usage de l’IA
- France – Surveillance des infections associées aux dispositifs invasifs en 2020
- France – HAS: Vers un cadre commun d’évaluation des dispositifs médicaux numériques en Union européenne – Lancement d’une taskforce européenne
- France – Intelligence Artificielle et DM : le brouillard des règles à appliquer
- France – Une approche des études PMCF alliant IA et données de vie réelle
- France – Concevoir un dispositif médical conformément à l’ISO 13485:2016
- France – HAS – CNEDiMTS : DEPREXIS (thérapie numérique): service attendu suffisant dans la dépression légère
- France – Comité d’interfaces ANSM/Industrie DM-DIV -Juin 2022) – 2
- France – Comité d’interfaces ANSM/Industrie DM-DIV -Juin 2022) – 1
- France – Plusieurs défis à relever pour assurer la sécurité des DM connectés (Afib)
- France – Réévaluation des défibrillateurs cardiaques automatiques implantables avec sonde(s) endocavitaire(s)
- France – Les logiciels de diagnostic in vitro : Nouveautés introduites par le Règlement (UE) 2017/746
- France – Cybersécurité des DM et DMDIV
- France – France 2030: 14 lauréats pour l’appel à manifestation d’intérêt « Santé numérique »
- France – Comment apporter une preuve clinique suffisante pour se conformer au RDM ?
- France – La medtech Dessintey dévoile sa nouvelle thérapie numérique de rééducation motrice
- France – ANSM authorizes production of drug delivery device under old directive
- France – Publication du référentiel d’interopérabilité et de sécurité des DM de télésurveillance
- France – Arrêté du 25 juillet 2022 portant approbation du référentiel d’interopérabilité et de sécurité des dispositifs médicaux numériques de télésurveillance
- France – Emballages de dispositifs médicaux : le LNE accrédité Cofrac
- France – Un système innovant pour l’administration du nez vers le cerveau de médicaments biologiques chez les nouveau-nés
- France – La HAS expérimente l’évaluation médico-économique des dispositifs médicaux numériques
- France – Rapport d’activité 2021 de la HAS
- France – Un risque réel de pénurie de Dispositifs Médicaux
- France – Ethypharm lance la première thérapie numérique dans la dépression sans attendre son éventuel remboursement
- France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs
- France – Implants Essure® : l’étain mis en cause dans la toxicité du dispositif
- France – HAS : LPPR : Dépôt d’un dossier auprès de la Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS)
- France – Seringue préremplie connectée au moyen d’un tag NFC
- France – LA HAS reconnait l’efficacité et l’utilité (ASA IV) du verre MiYOSMART (HOYA VISION CARE FRANCE) pour freiner la progression de la myopie
- Catégorie : Europe
- Europe – Experts outline challenges of combination products in Europe
- Switzerland – New organisational structure with separate Medical Devices Surveillance Sector
- Europe – The European Medical Technology in Figures 2023
- Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR applications
- Europe – European Commission approves updated regulation to ease contact lens UDI requirements
- Europe – European Parliament votes to extend MDR transition period
- USA – Switzerland eyes allowing FDA-approved medical devices onto its market
- Europe – European Notified Body survey: MDR, IVDR certification numbers remain low
- UK – MHRA : Implementation of the Future Regulations
- Europe – New study shows pioneering test for endometrial cancer could significantly reduce diagnosis time
- Europe – New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR
- Europe – Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
- Europe – CAMD Statement – 50th CAMD Plenary meeting
- UK – MHRA joins international partnerships to set global standards for medicines and medical devices regulation
- Europe – Artificial intelligence in healthcare
- UK – Medical devices: UK approved bodies
- Europe – Implementing the Medical Devices Regulation (MDR)
- Catégorie : Amériques
- Catégorie : Asie-Pacifique
- Catégorie : Découverte
- Catégorie : Cosmétiques
- Catégorie : France
- Catégorie : Europe
- Europe – Règlement 2022/1181 : nouvelles règles d’étiquetage pour les produits contenant des libérateurs de formaldéhyde
- Europe – Cosmetics Europe veut un Règlement cosmétique basé sur la science
- Europe – Upcoming changes to REACH information requirements
- Europe – Group assessment of bisphenols identifies need for restriction
- Europe – Pharmaceutical industry provides unpublished data on chemical substances
- Europe – Projet of transfert du SCCS Sous la responsabilité de l’ECHA : COSMED pointe les risques
- Catégorie : International
- China – China Issues Guidelines on Children’s Cosmetics
- Australia – TGA publishes updated guidelines for sunscreens
- USA – « Global harmonization »: Review of regulation around the cosmetic world
- Brazil – Consensus en faveur d’une interdiction fédérale des tests sur animaux
- China – Safety and Technical Standard for Cosmetics 2022 (STSC 2022)
- Catégorie : Santé Publique
- 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
- France – La Haute Autorité de santé recommande de vacciner tous les nourrissons contre les rotavirus.
- France – La Cnam crée un département « télésanté et innovation numérique »
- France – Assurance maladie complémentaire: la Cnil appelle à renforcer le cadre juridique pour l’utilisation des données de santé
- France – Doctolib retirera les thérapeutes alternatifs de sa plateforme d’ici six mois
- USA – FDA warns e-cig companies over products that look like toys and target children
- France – Amazon Care est mort, vive Amazon Clinic!
- USA – Maladie de Charcot : l’espoir d’un nouveau traitement
- International – WHO: Global COVID-19 deaths down 90% since February
- France – Un bel exemple
- France – François Braun lance le catalogue Mon espace santé doté de ses 12 premières applications référencées
- UK – Lab-grown red blood cells used for human transfusions in world-first clinical trial
- France – Coup d’envoi de l’Agence de l’innovation en santé
- France – Santé : les prescriptions d’antibiotiques aux enfants repartent à la hausse
- France – Une télésurveillance de plus en plus basée sur les preuves (SFSD)
- France – Variole du singe : malgré une baisse des cas, l’OMS estime qu’il reste des « raisons de s’inquiéter »
- International – WHO publishes first-ever fungal priority pathogens list in face of antimicrobial resistance
- USA – Covid long : les États-Unis vont tester l’efficacité du médicament Paxlovid
- France – Doctolib va déréférencer les professions non réglementées, comme les naturopathes et les magnétiseurs, annonce son PDG
- France – Bronchiolite : l’épidémie continue de progresser partout en France sur fond de crise de la pédiatrie
- France – Budget de la « Sécu » : les laboratoires d’analyse menacent de cesser la transmission des données des tests de dépistage du Covid-19
- France – CerHom : une association dont la vocation est de lutter contre les cancers masculins.
- France – Covid-19 : les vérités d’Agnès Buzyn sur la gestion de la pandémie
- France – Covid-19 : une huitième vague de d’« intensité modérée » en France, où « une croissance rapide du variant BQ.1.1 » a été détectée
- France – Les laboratoires français assurent qu’il n’y a pas de pénurie de paracétamol
- France – Levothyrox : chronologie de l’affaire, de la commercialisation de la nouvelle formule à la mise en examen de Merck
- France – Retour sur le Sommet mondial de la Santé : « Faire le choix de la santé », à l’échelle mondiale et au-delà des crises
- France – Implants contraceptifs Essure : une étude, non publiée par l’agence sanitaire, avait alerté sur les dangers
- France – Levothyrox : la filiale française du laboratoire Merck annonce sa mise en examen pour « tromperie aggravée »
- Europe – Prosecutor confirms probe into Europe’s COVID-19 vaccine purchasing
- France – Coronavirus : identification de nouvelles protéines qui régulent l’infection
- International – Le décret de la discorde
- France – Une avancée majeure pour le système de santé : l’ensemble des ordres des professions de santé ont remis leur position commune aux ministres François Braun et Agnès Firmin Le Bodo pour répondre aux problématiques d’accès à la santé dans les territoires publié le13.10.22
- France – PLFSS: les députés en faveur d’un renforcement du cadre d’interopérabilité et de sécurité des services numériques en santé
- Haiti – Haiti risks new diseases amid cholera outbreak that has killed 18, says PAHO
- International – Lebanon announces first death from cholera since detecting the disease in October
- France – Cyberattaque: les enseignements tirés par le DSN et le chef de la pharmacie du CH de Villefranche-sur-Saône
- USA- Heart surgeons want to do more xenotransplants
- France – Encéphalite à tiques : remonter à l’origine des cas de transmission via le fromage
- France – Budget de la Sécurité sociale : les concessions du gouvernement aux laboratoires pharmaceutiques
- USA – New study finds brains of ‘superagers’ contain larger neurones in memory region
- International – L’OMS alerte et ouvre une enquête sur des sirops contre la toux et le rhume après la mort de 66 enfants en Gambie
- International – WHO unveils new initiative to halt spread of invasive malaria vector in Africa
- France – La discrète arrivée de Sephora sur le marché de la parapharmacie
- France – « La refondation du système de santé doit démarrer dès 2023 »
- France – Don de sang: la France condamnée pour la collecte de données sur l’orientation sexuelle (CEDH)
- International – WHO announces recommended 2023 flu vaccines for southern hemisphere
- France – Recommandations concernant l’usage des produits de vapotage / cigarette électronique
- France – Projet de loi de financement de la sécurité sociale (PLFSS) pour l’année 2023
- USA – COVID-19 linked to long-term neurologic disorders in new US study
- France – Budget de la « Sécu » 2023 : les comptes se redressent
- Europe – EU health regulator says COVID pandemic not over
- International – Pfizer to supply 6 million Paxlovid treatments to low- and middle-income countries
- France – Le gouvernement rend gratuit l’accès à la pilule du lendemain pour toutes et le dépistage des IST
- France – Prévention : des consultations médicales bientôt gratuites à 25, 45 et 65 ans
- France – L’association Sauv Life déploie un dispositif paramédicalisé de téléconsultation à domicile
- International – Sanofi remporte un succès dans un vaccin contre la bronchiolite
- France – Fin de vie : l’ordre des médecins, opposé à l’euthanasie, réclame une « clause de conscience »
- USA – FDA and NIHR launch public-private partnership for rare neurodegenerative diseases
- International – Covid-19 : le tableau de bord de l’épidémie
- France – Variole du singe : l’épidémie reflue grâce à la vaccination et à l’évolution des comportements
- France – Justice : la directrice générale de Santé publique France relaxée
- International – WHO calls for greater investment into research for millions living with long COVID
- Brazil – Une mère de 19 ans donne naissance à des jumeaux ayant des pères biologiques différents
- France – La justice face à la plainte en diffamation de Didier Raoult contre Karine Lacombe
- France – Publication du décret relatif au traitement des données personnelles dans le cadre d’un don de gamètes
- International – Machine-learning algorithm to non-invasively detect diabetes and pre-diabetes from electrocardiogram
- France – Données personnelles: Doctolib défend la mise à jour de ses conditions d’utilisation
- France – En pleine polémique, Doctolib suspend 17 profils liés à une naturopathe controversée
- France – Le lancement de la carte Vitale biométrique inscrit au PLFR 2022
- Europe – EMA response to the monkeypox public health emergency
- France – Covid-19 : la « fin des régimes d’exception » en France actée avec l’adoption du projet de loi sanitaire
- International – WHO advances plan for first malaria vaccine roll out in Africa
- International – Monkeypox Symptoms Described in Large International Study
- International – New diabetes reference guide focuses on helping pharmacists achieve required competencies
- France – Les dispositifs portables de détection des crises d’épilepsie plus ou moins bien acceptés par les patients
- International – La poliomyélite refait surface malgré les efforts pour l’éradiquer
- International – Variole du singe : l’OMS déclenche son plus haut niveau d’alerte
- France – Expérimentation: 1.774 téléconsultations d’ophtalmologie réalisées dans l’Aisne
- France – Covid-19 : la HAS préconise le maintien de l’obligation vaccinale des personnels exerçant dans les établissements de santé et médico-sociaux
- USA – Un cas de polio détecté aux Etats-Unis pour la première fois depuis 2013
- France – Le projet de loi sanitaire, et la fin des régimes d’exception pour lutter contre l’épidémie de Covid-19, approuvés par le Sénat
- UK – Over 285,000 medicines and medical devices seized UK-wide in global action
- France – Vaccin contre le Covid-19 : les femmes qui subissent des troubles menstruels sont invitées à les déclarer
- Europe – Europe must act now or risk tougher COVID measures later, WHO official says
- France – Le « tout numérique » accroît les inégalités d’accès aux soins
- France – La CNIL adopte un référentiel sur la gestion des officines de pharmacie
- Canada – Health Canada authorizes use of Moderna COVID-19 vaccine in children 6 months to 5 years of age
- International – Researchers create ‘world’s largest’ database for predicting cancer treatment response
- France – Monkeypox : Mise en œuvre de la vaccination et n° d’information
- France – Ce que l’on sait des réinfections au Covid-19 : sont-elles plus fréquentes, quelles personnes sont majoritairement concernées ?
- France – Le projet de loi sanitaire provoque des débats électriques à l’Assemblée nationale
- France – HAS : Monkeypox : une vaccination préventive proposée aux personnes les plus à risque d’exposition
- Switzerland – New Swiss research reveals how Omicron evades the immune system
- USA – FDA allows pharmacists to prescribe Pfizer’s COVID-19 pill
- France – Lucile Blaise élue présidente du Snitem
- France – Variole du singe : l’OMS appelle à une action « urgente » en Europe compte tenu de la flambée des cas
- Europe – Les évaluations du cannabidiol en tant que nouvel aliment sont suspendues dans l’attente de nouvelles données
- Europe – La Commission européenne propose d’interdire les versions aromatisées de tabac chauffé
- France – Covid-19 : les consignes de prudence minimales du gouvernement
- USA – Intérêt de la thérapie cognitivo-comportementale numérique pour améliorer l’insomnie et réduire une prise de cannabis associée
- International – Enanta takes legal action against Pfizer over Paxlovid patent infringement
- France – Variole du singe : 330 cas confirmés en France, l’OMS appelle l’ensemble des pays à la transparence
- France – La HAS lance QualiScope : le service en ligne qui permet à tous de s’informer sur le niveau de qualité des hôpitaux & cliniques
- France – « Data Pathologies »: l’assurance maladie lance un site sur les dépenses de santé
- France – Comment les données de vie réelle accélèrent la recherche sur les maladies rares
- Europe – Research from Imperial College London shows single brain scan could diagnose Alzheimer’s disease
- UK – Blood vessel breakthrough is major step towards Alzheimer’s treatment
- International – WHO to convene emergency committee on monkeypox
- France – Attention aux appels et courriels frauduleux usurpant le nom de l’ANSM
- Europe – EU governments pressure manufacturers to renegotiate contracts for COVID-19 vaccines
- Europe – COVID-19: Council and European Parliament reach a provisional political agreement to extend the regulation establishing the EU digital COVID certificate
- International – Variole du singe : comment se transmet-elle, quels sont les symptômes ?
- France – Covid-19 : le tableau de bord de l’épidémie
- France – Santé : tout un système à revoir
- France – Le HCSP prône des évolutions du carnet de santé de l’enfant en vue de son passage au numérique
- France – La DNS publie des recommandations pour une « conception éthique » de l’IA
- France – Variole du singe : l’infectiologue Karine Lacombe se dit « plutôt inquiète »
- USA – Cancer colorectal: la détection d’adénomes par coloscopie améliorée par une IA
- Africa – Variole du singe : les pays africains réclament un accès équitable au vaccin
- India – Serum Institute of India considering expansion into Africa
- France – Risques neurologiques et psychiatriques des formes longues de Covid-19
- Mexico – La cigarette électronique interdite au Mexique
- Israël – L’intelligence artificielle pourrait raccourcir le diagnostic du rhumatisme psoriasique
- France – Vers une épidémie mondiale de variole du singe ? Martin Blachier brise le silence !
- Europe – First The UK, Now France: Is Needle-Spiking Spreading In European Clubs?
- France – HAS : Monkeypox : vacciner les adultes et professionnels de santé après une exposition à la maladie
- USA – FDA takes steps to relax blood donor requirements
- France – Variole du singe : un premier cas d’infection confirmé en France
- France – Premières expérimentations du congé menstruel en France : un bilan mitigé
- International – Monkeypox confirmed in the U.S. and Europe
- France – Dépakine : Sanofi condamné à indemniser une famille dont la fille est née avec des malformations
- USA – Some patients reporting COVID rebounds after taking Pfizer pills
- International – WHO calls on Pfizer to make its COVID pill more available
- International – WHO releases estimates of 14.9 million excess deaths during COVID-19 pandemic
- Europe – Covid-19 : pourquoi l’Agence de sécurité du médicament retire du marché le spray nasal Previdspray ?
- Europe – Commission proposes European Health Data Space to unlock research opportunities
- France – Médecins: la liste des documents à verser obligatoirement au DMP fixée par arrêté
- USA – Hépatites inexpliquées : les Etats-Unis lancent une enquête sur la mort de cinq enfants
- UK – New long COVID study highlights key symptoms
- Europe – COVID-19 – Sustaining EU Preparedness and Response: Looking ahead