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- Catégorie : DM-DIV
- UK – MHRA releases spate of new guidelines on decentralized manufacturing
- USA – FDA issues guidance on transferring 510(k) ownership
- Europe – EU plan would limit Chinese device makers in Europe
- USA – FDA final guidance adds more details to Q-Sub program
- France – Nouvel avis sans recommandation de la Cnedimts sur le remboursement d’un DM de télésurveillance cardiaque
- Europe – Study supporting the monitoring of the availability of medical devices on the EU market
- USA – Medical Devices Regulatory Update / FDIS 10993-1 Released: Requirements and General Principles for the Evaluation of Biological Safety Within a Risk Management Process
- UK – The Medical Devices (Amendment) (Great Britain) Regulations 2025 (Draft)
- USA – FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
- Australia – Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)
- Europe – MIR PDF 7.3.1 New MIR form – mandatory as from November 2025
- International – ISO 10993-23: 2021/Amd.1:2025 – Biological evaluation of medical devices — Part 23: Tests for irritation Amendment 1: Additional in vitro reconstructed human epidermis models
- UK – Nice recommends first AI medical device for skin cancer diagnosis in the NHS
- Europe – EUDAMED user guide : UDI Devices
- Europe – European Artificial Intelligence Act (Version 2)
- Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
- UK – Clinical investigations of medical devices – guidance for manufacturers
- International – ISO 15223-1:2021/Amd 1:2025 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
- International – Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form
- International – IMDRF guidance details when regulators should share postmarket surveillance reports
- USA – FDA reissues sex-specific data guidance after sanitizing anything considered DEI-related
- Canada – Health Canada Continues to Actively Monitor Supply of Medical Devices
- Europe – Risk Categorization Per the European AI Act
- Europe – Pilot on the Advice from the Expert Panels to Manufacturers of HighRisk Medical Devices
- France – Mesure de glycémie sans piqûre : l’ANSM et la DGCCRF alertent sur les risques pour la santé des montres, bagues ou autres moniteurs connectés
- Europe – Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025)
- Europe – EU device expert warns manufacturers not to wait until the last minute to transition their products
- Europe – Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body
- Europe – Urgent call for clarity on clinical strategy discussions
- France – Un pas de plus dans la lutte contre l’endométriose : lancement du test salivaire Endotest®
- Canada – Draft guidance on managing applications for medical device licences
- Europe – The Commission publishes guidelines on AI system definition to facilitate the first AI Act’s rules application
- UK – Decision tree for navigating nanotechnology-based products for medical application
- Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products
- Europe – Règlement (UE) 2025/40 du Parlement européen et du Conseil du 19 décembre 2024 relatif aux emballages et aux déchets d’emballages, modifiant le règlement (UE) 2019/1020 et la directive (UE) 2019/904, et abrogeant la directive 94/62/CE (Texte présentant de l’intérêt pour l’EEE)
- Switzerland – Swissmedic assessment of post-market surveillance documentation
- Europe- MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies
- France – Accès dérogatoire pour un dispositif médical dépourvu de marquage CE : optimisation du processus de demande à l’ANSM
- Europe – European Commission announces pilot for coordinated assessment of clinical investigations
- France – Endométriose : le gouvernement annonce le remboursement de tests salivaires pour certaines femmes
- Europe – EMA establishes regular procedure for scientific advice on certain high-risk medical devices
- USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
- International – IMDRF finalizes good machine learning practice, software risk documents
- Europe – Règlement D’exécution (UE) 2025/117 de la Commission du 24 janvier 2025
- Europe – Revised versions and new guidance are available in the EMDN section
- UK – MHRA guidance on new Medical Devices Post-Market Surveillance requirements
- UK – Implementation of medical devices future regime
- USA – FDA finalizes guidance on reporting medical device shortages
- Europe – MDCG 2024-8 Rev. 1 Preliminary assessment review template – IVDR (Regulation (EU) 2017/746) Revision 1 – January 2025
- Europe – MDCG 2024-7 Rev. 1 Preliminary assessment review template – MDR (Regulation (EU) 2017/745) Revision 1 – January 2025
- USA – FDA updates GUDID final guidance
- Canada – Guidance on terms and conditions for class II to IV medical devices
- Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D IVDs by notified bodies (December 2024)
- Canada – Drug and medical device databases
- Europe – MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation – December 2019
- Europe – Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
- Europe – Commission launches a public consultation and a call for evidence for EU Medical Devices evaluation
- UK – Medical Devices Regulatory Reform – Roadmap to implementation – Update
- Europe – MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
- USA – Final FDA guidance on PCCP includes clarification on version control
- Europe – MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)
- Europe – Medical devices AI questionnaire IG-NB & Team NB
- Europe – MDCG 2024-14 – Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)
- France – PLFSS 2025: le gouvernement veut actionner la clause de sauvegarde sur les dispositifs médicaux
- Europe – Gradual roll out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024)
- USA – FDA finalizes guidance on 510(k) third-party reviews
- USA – The regulatory landscape of ingestible medical devices in the United States
- UK – Medical Devices Regulations: Routes to market and in vitro diagnostic devices
- France – Implants et prothèses dentaires : avis favorable de la HAS pour leur remboursement dans les édentements complet ou unitaire
- Europe – MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- Europe – Experts: Notified body survey shows MDR/IVDR progress despite some snags
- Europe – Q&A Obligation to inform in case of interruption or discontinuation of supply
- USA – Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing: A White Paper for Medical Device Manufacturers
- Europe – Notified body official shares recommendations for successful PMCF plans
- Europe – MDCG 2022 – 5 Rev. 1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices – October 2024
- Europe – MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices – October 2024
- UK – UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?
- Europe – EMA official reports on scientific advice pilots for high-risk and orphan devices
- Europe – Team-NB views on implementation of MDR/IVDR Regulations
- Europe – Urgent need to revise the medical devices regulation
- France – La HAS émet un avis favorable à l’octroi d’un forfait innovation pour le test salivaire Endotest
- Europe – Stakeholders disagree over need for ‘urgent action’ on MDR/IVDR
- UK – Implementation of medical devices future regime : Implementation of the future regulations – Updated 22 October 2024
- Europe – Règlement d’exécution (UE) 2024/2699 de la Commission du 18 octobre 2024
- Europe – Open letter to Stella Kyriakides on the urgent need for action on the medical technology regulations
- Australia – How to submit a custom-made medical device / patient-matched medical device notification – Step-by-step guide
- Australia – Understanding personalised medical devices rules (including 3D-printed devices) – Regulatory changes for custom-made medical devices
- Australia – Refinements to the Personalised Medical Device Framework
- Europe – MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
- International – RF Quarterly, September 2024: Artificial intelligence in medical devices
- UK – MHRA to launch consultation on device international reliance plan by year’s end
- Canada – Health Canada digital health head says AI/ML guidance imminent
- Europe – Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects
- Europe – Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products
- Europe – MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
- India – Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & Family Welfare becomes Affiliate Member of the International Medical Device Regulators Forum (IMDRF)
- Europe – MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams – October 2024
- UK – MHRA e-cigarette and vape products regulator profile
- France – La HAS réévalue les systèmes connectés de prise en charge du diabète
- UK – An update on our plans for Med Tech regulatory change
- Europe – Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746
- Europe – MDCG 2021-4 rev.1 – Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 – September 2024
- USA – FDA names new head of medical device evaluation and quality
- USA – FDA releases three post-pilot ASCA draft guidances
- International – The global regulatory landscape for AI/ML-enabled medical devices
- International – Artificial intelligence in medical devices
- Europe – Notification of a Body in the framework of a technical harmonization directive
- USA – FDA Authorizes First Over-the-Counter Hearing Aid Software
- USA – Industry groups call for changes to FDA’s guidance on use-related risk analyses
- Canada – The evolution of Canada’s medical device regulatory framework
- USA – FDA updates patient preference guidance to span the product life cycle
- Europe – EU Update: Current State of Medical Device Regulations
- International – IMDRF Document Implementation Report – Final document
- International – ISO/DIS 10993-1(en) Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
- Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards for medical devices
- Europe – New pilot programme to support orphan medical devices
- USA – FDA unveils FY 2025 user fee rates
- Europe – Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
- USA – FDA finalizes COVID-era guidance on container closure changes
- Europe – Medical device competent authority statement on the status of the EU regulatory system
- Europe – Règlements européens relatifs aux dispositifs médicaux et de diagnostics in vitro : publication d’un « consensus statement » à destination de la Commission européenne
- France – Analyse des déclarations de la base nationale des évènements indésirables graves associés aux soins (EIGS) en lien avec les dispositifs médicaux
- Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards for medical devices
- China- Medical Device Administrative Control System (MDACS)
- France – Ballons gastriques Allurion : recommandations pour limiter la survenue de complications graves
- USA – FDA issues final guidance user fees for combination products
- USA – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
- Europe – Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024
- USA – FDA releases draft guidance on use-related risk analysis for combo products
- Europe – Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024
- International – Lancement de la plateforme MeDevIS pour améliorer l’accès aux technologies et dispositifs médicaux
- Europe – MDCG 2020-16 Rev.3 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – July 2024
- France – Déclarer l’indisponibilité d’un dispositif médical : la procédure évolue
- International – ISO/DIS 14155 will replace ISO 14155:2020
- International – 1SO 10933-1:2018 will be replaced by ISO/DIS 10993-1
- International – IMDRF publishes AI/ML guiding principles echoing US, UK, Canadian regulators
- USA – FDA drafts guidance on essential outputs for drug delivery devices
- UK – Medical devices: UK approved bodies
- Europe – MDCG 2021-5 Rev. 1 : Guidance on standardisation for medical devices
- USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
- Europe – MDCG 2024-10 Clinical evaluation of orphan medical devices
- Switzerland – Swissmedic prepares medtech industry for activation of medical devices database module
- Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments
- Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
- Europe – Phthalates in certain medical devices: updated SCHEER guidelines published
- Australia – Medical device regulation changes
- France – Le Grand Défi « Dispositifs médicaux numériques en santé mentale »
- Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies – June 2024
- International – FDA, Health Canada, MHRA release guiding principles on transparency for machine learning medical devices
- Europe – MDCG 2024-1-5 : Guidance on the vigilance system for CE-marked devices DSVG 05 : Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence
- Europe – Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices in the EU
- Europe – Annual report 2023
- France – Acide hyaluronique : les autorités sanitaires renforcent la réglementation en rendant la prescription médicale obligatoire
- Europe – Medical devices: Council adopts new measures to help prevent shortages
- Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
- Europe – MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
- Switzerland – Des paralytiques retrouvent l’usage de leurs mains grâce à un dispositif de stimulation externe
- France – Règlement européen relatif aux dispositifs médicaux : fin de la période de transition
- UK – Home testing devices could increase the number of people diagnosed with sleep condition
- UK – MHRA announces a proposed framework for international recognition of medical devices
- Europe – EMA revises Q&A guidance on drug-device combination products
- Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
- Europe – Medical devices: new guidance for industry and notified bodies
- UK – EM on EU regulations 2017/745 & 2017/746 (COM(2024)43)
- USA – FDA concerned about potential device shortages due to new EtO limits
- Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
- USA – FDA issues long-awaited device remanufacturing guidance
- UK – MHRA’s AI Airlock to address challenges for regulating AI medical devices
- International – Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
- International – Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
- International – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
- International – Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
- International – Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
- International – Final Document- Principles of Labelling for Medical Devices and IVD Medical Devices
- Europe – Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics
- International – FDA warns Philips about imaging device violations at China facility
- 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
- France – Tests génétiques sur Internet : la CNIL appelle à la vigilance
- Europe – Recent ECJ ruling could lead to standards development tumult
- USA – FDA panel’s green light on glaucoma wearable device offers hope in sight
- USA – FDA wants sponsors to test devices that may cause tissue temperature changes
- USA – FDA warns consumers against using plastic syringes made in China
- Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing
- USA – EPA finalizes rule to reduce EtO emissions from sterilization facilities
- USA – FDA proposes updates to device cybersecurity guidance
- Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
- Europe – New Notified Body Designated Under EU MDR
- Europe – Normes Harmonisées 2024/817
- Europe – Normes Harmonisées 2024/815
- UK – New action to tackle ethnic and other biases in medical devices
- USA – FDA official discusses use cases, limits for device PCCPs
- usa – Industry calls for changes in FDA’s RWE guidance for devices
- USA – FDA official warns device makers over supply chain risks
- Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux DM
- Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech legislation
- Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
- USA – FDA proposes down-classifying most high-risk IVDs
- Europe – Experts outline challenges of combination products in Europe
- Europe – MDCG endorsed documents and other guidance
- USA – FDA updates guidance on remote regulatory assessments
- Europe – User guide for micro, small and medium-sized enterprises
- USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
- USA – FDA proposes guidance on orthopedic product coatings
- Europe – Commission proposes measures to improve the availability of in vitro diagnostics
- Europe – Regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC
- France – DTx : la réglementation se met progressivement en place
- Europe – Overview of language requirements for manufacturers of medical devices
- UK – Medical devices: UK approved bodies
- UK – Implementation of medical devices future regime
- France – Diagnostic complexe d’endométriose : la HAS propose un accès au test salivaire Endotest® dans le cadre du forfait innovation
- USA – FDA updates sterilization category to encourage vaporized hydrogen peroxide use
- Canada – Amendments to the Medical Devices Regulations to address future public health emergencies
- Europe – MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence
- Switzerland – New organisational structure with separate Medical Devices Surveillance Sector
- UK – Heart vests to identify those at high risk of sudden cardiac death
- UK- Wearable technology to be offered to thousands with type 1 diabetes in UK
- USA – FDA updates third party 510(k) guidance
- Europe – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025 deadline for Class D IVDs
- Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
- Europe – MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products : A guide for manufacturers and notified bodies
- Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
- Europe – Update – MDCG 2021-6 – Rev.1 – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation – December 2023
- USA – Experts discuss red flags that can trigger legal action against drug and device makers
- Europe – Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
- USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR and LDT rules
- USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
- France – Conception orientée production : que faire pour les DM les plus complexes ?
- 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
- France – Conformité du marquage UDI : la norme ISO sur les Data Matrix évolue
- 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
- International – IMDRF publishes new procedures on membership, governance
- Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
- Europe – Experts outline current knowledge on AI and medical devices
- International – Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
- UK – MHRA and international partners publish five guiding principles for machine learning-enabled medical devices
- USA – FDA revises final guidance on modifying remote monitoring devices
- Europe – In vitro diagnostic device regulation in Europe: Update on revisions
- Europe – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
- Europe – Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses
- Europe – The European Medical Technology in Figures 2023
- USA – FDA revises magnetic resonance guidance to reflect updated international standard
- USA – FDA’s CDRH releases list of proposed guidances for FY 2024
- USA – Diversity plan draft guidance on track before year end, FDA official says
- USA – Convergence: Tips for when to include PCCPs in product submissions
- USA – The biggest misconception regulatory professionals have about the FDA 510(k) program, according to Mark DuVal
- Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist
- USA – FDA updates physiologic closed-loop control final guidance with industry feedback
- USA – FDA guidance explores trial design, supporting data for GVHD treatments
- USA – New guidances outline eSTAR submission requirements for de novo and 510(k) device applications
- USA – FDA proposes long-awaited LDT enforcement rule
- USA – FDA premarket cybersecurity guidance clarifies SBOM requirements
- Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs a year, report claims
- USA – Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
- USA – FDA guidances keep coming, new device harmonization plan, and more
- UK – Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
- USA – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Europe – Ongoing consultations under the PECP
- Europe – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices
- International – IMDRF guidance updates thinking on personalized 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 »
- France – Déodorant Nuud : retrait du marché par le fabricant de l’ensemble des lots de ce déodorant
- 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
- International – E-labeling and digital transformation in healthcare
- Europe – Evaluation clinique : retours d’expérience d’un organisme notifié
- UK – Three new UK Approved Bodies to certify medical devices announced by the MHRA
- UK – Medical devices: UK approved bodies
- Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR applications
- USA – FDA issues final guidance on obtaining informed consent in drug and device clinical trials
- UK – NICE recommends AI technologies for radiotherapy treatment planning
- UK – Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the capsule around breast implants
- Europe – MDR/IVDR survey shows NBs have increased capacity
- USA – Opioid use disorder: FDA drafts guidance on clinical considerations for devices
- UK – Implementation of medical devices future regime
- France – HAS : Dispositifs médicaux numériques à usage professionnel
- USA – FDA recognizes new medical device sterilization standards
- UK – Software and Artificial Intelligence (AI) as a Medical Device
- Europe – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices REV. 1
- USA – FDA warns device makers for GMP issues, unauthorized uses
- Europe – European Commission approves updated regulation to ease contact lens UDI requirements
- Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/745
- France – Laurence Comte-Arassus élue présidente du Snitem
- 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
- France – Sécurisation des prescriptions: Vidal décroche le marquage CE classe IIb pour son logiciel de DM
- 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
- France – Rapport annuel du Snitem – 2023
- 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
- France – L’ANSM demande aux fabricants de dispositifs médicaux qui envoient un avis de sécurité d’y apposer le code-barres des dispositifs concernés
- 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
- Catégorie : DM DIV International
- Catégorie : DM DIV France
- Catégorie : DM DIV Europe
- Europe – EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH) in biopsy samples
- Europe – MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- Europe – MDCG 2023-3 Rev. 2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 January 2025
- UK – MHRA announces consultation on improved safety for high risk in vitro diagnostic devices
- Catégorie : DM DIV Amériques
- Catégorie : DM DIV Asie-Pacifique
- Catégorie : DM DIV Découverte
- Catégorie : Non classé
- Catégorie : Médicaments
- USA – FDA drafts guidance, orders on minor changes to OTC drugs and packaging
- UK – NICE recommends Sogroya for growth hormone deficiency in children
- Europe – EU Council adopts compromise position on pharma reforms
- Europe – New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials
- USA – FDA approves darolutamide for metastatic castration-sensitive prostate cancer
- UK – NICE recommends mirikizumab for Crohn’s disease treatment
- UK – NICE recommends sparsentan for IgA nephropathy
- UK – AstraZeneca’s Forxiga recommended by NICE for wider chronic kidney disease use
- USA – FDA proposes downgrading drug color additive changes to CBE-30
- Europe – Changes to the use of antibiotic azithromycin
- Europe – EMA starts review of ipidacrine-containing medicines
- Europe – New treatment for adults with acute lymphoblastic leukaemia
- Europe – External guidance on the implementation of the European Medicines Agency Policy 0070 on the publication of clinical data for medicinal products for human use
- France – Cancers : en France, la création d’une nouvelle molécule conçue pour éliminer les cellules métastatiques
- UK – NHS and local government to roll out world-first vaccine programme to prevent gonorrhoea
- USA – FDA sets stricter approval standards for COVID vaccines
- Europe – ETF recommends updating COVID-19 vaccines to target new LP.8.1 variant
- UK – MHRA approves first UK treatment for congenital thrombotic thrombocytopenic purpura (cTTP)
- Europe – EMA proposes to incorporate Annex 1 in GMP guide for ATMPs
- France – Grippe saisonnière : la HAS précise la place des vaccins Efluelda et Fluad dans la stratégie vaccinale
- Switzerland – Swissmedic mandates nitrosamine risk assessments in some applications
- USA – FDA to expand unannounced foreign inspections after Trump executive order
- Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
- Europe – Leveraging the power of data for public and animal health
- UK – MHRA approves teprotumumab as the first UK treatment for adults with moderate to severe Thyroid Eye Disease (TED)
- Europe – EMA starts review of Ixchiq (live attenuated chikungunya vaccine)
- France – La guerre du paracétamol est déclarée entre les pharmaciens et le groupe E.Leclerc
- UK – NHS rolls out 5-minute ‘super-jab’ for 15 cancers
- Europe – New treatment against Duchenne muscular dystrophy
- UK – MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone
- Europe – First treatment against severe thyroid eye disease
- UK – AstraZeneca’s Truqap recommended by NICE to treat advanced breast cancer
- Europe – Revised general chapters for elemental analysis published in Pharmeuropa 37.2
- USA – FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
- UK – First treatment for common bladder cancer recommended by NICE
- Europe – European Parliament adopts pharmaceutical reform package
- Europe – European Commission approves ustekinumab for paediatric Crohn’s disease
- UK – Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy
- Europe – EPC adopts groundbreaking chapter on cell-based preparations for human use
- Europe – Public consultation on revised general chapter 5.1.6. Alternative methods for control of microbiological quality in Pharmeuropa 37.2
- UK – NICE recommends brentuximab vedotin plus AVD for Hodgkin lymphoma
- UK – Alcohol-mediated perivascular renal sympathetic denervation for resistant hypertension
- Europe – Streamlining development and assessment of biosimilar medicines
- Europe – Pharmeuropa 37.2 just released
- Europe – Development of a guideline on the quality aspects of mRNA vaccines – Scientific guideline
- Europe – EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
- Europe – The evolution of biologicals in the European Pharmacopoeia
- Europe – Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028
- UK – NICE recommends Pharming’s Joenja as first treatment for ultra-rare immune disease APDS
- USA – FDA approves first treatment for adults with complement 3 glomerulopathy, a rare kidney disease, to reduce proteinuria
- Europe – Finding clinical trials with the ACT EU Trial Map
- USA – FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting
- UK – NICE recommends Gideon Richter’s Ryeqo as first daily pill for endometriosis
- UK – Merck KGaA’s Mavenclad tablets recommended by NICE for wider MS use
- France – Chez Sanofi, la vente de l’Aspégic fait craindre « un effet domino »
- Europe – Commission proposes Critical Medicines Act to bolster the supply of critical medicines in the EU
- Europe – EMA spells out data access policy for shortage monitoring platform
- USA – Experts propose restricting trademarks on accelerated approval drugs to speed confirmatory trials
- UK – Sobi receives NICE recommendation for Altuvoct in severe haemophilia A
- Europe – New clinical trial map launched in the EU
- Canada – Submitting risk management plans guidance document: Overview
- Europe – First topical gene therapy treatment for dystrophic epidermolysis bullosa
- Europe – Combination of cystic fibrosis medicines to treat patients with rare mutations
- UK – mRESVIA RSV vaccine approved to protect patients aged 60 and over
- Europe – Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome – Scientific guideline
- UK – Amgen’s Blincyto recommended by NICE for new adult leukaemia indication
- UK – NICE recommends pharmaand’s Rubraca for advanced ovarian cancer
- Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
- USA – FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs
- UK – NHS rolls out life-changing treatment offering ‘new hope’ for hundreds of children with severe epilepsy
- UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
- UK – Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A
- USA – FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
- UK – Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK
- UK – Access, new active substance and biosimilar work sharing initiatives
- UK – Decision tree for navigating nanotechnology-based products for medical application
- Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products
- Europe – Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development
- Europe – Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials
- USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
- UK – MHRA drafts mRNA cancer immunotherapy guidance
- Europe – Clinical Trials Regulation becomes fully applicable
- UK – NICE approves Vertex’s Casgevy one-time gene therapy for sickle cell disease
- USA – FDA approves new Alzheimer’s treatment regimen
- Europe – European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU
- Europe – New combination of medicines to treat parasitic worm infections
- USA – CDER announces new guidance agenda for 2025
- UK – AstraZeneca receives NICE recommendations for lung cancer drugs Tagrisso and Imfinzi
- Europe – European Pharmacopoeia Commission adopts first three general texts on mRNA vaccines
- USA – FDA draft guidance outlines appropriate use of tissue biopsies in clinical trials
- USA – FDA proposes to modernize guidance on sex, gender in clinical trials
- USA – CDER approved 50 novel drugs in 2024, record number of biosimilars
- UK – NICE recommends olaparib for BRCA-mutated breast cancer treatment
- UK – AstraZeneca’s Lynparza recommended by NICE to treat advanced breast cancer
- USA – FDA finalizes advanced manufacturing technology designation guidance
- USA – FDA proposes update to 18-year guidance on developing weight loss drugs
- USA – AI in drug development: FDA draft guidance addresses product lifecycle, risk
- USA – Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing
- Europe – A common EU approach to data transparency in medicine regulation
- Europe – Successful pilot paves the way for implementation of ePI
- Europe – First medicine to treat rare genetic disorder causing cysts and tumours
- UK – NICE recommends Santhera’s Duchenne muscular dystrophy drug Agamree
- Europe – First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024
- Europe – First treatment recommended for rare progressive lung conditions in children and adolescents
- Canada – Drug and medical device databases
- UK – NICE endorses Neuraxpharm’s ublituximab for treating MS
- UK – NICE recommends Immunocore’s Kimmtrak as first drug for aggressive eye cancer
- USA – Researchers suggest FDA needs authority to require pediatric studies for orphan drugs
- USA – FDA finalizes BIMO electronic submission guidance
- USA – Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
- USA – FDA recommends collecting ovarian toxicity data in cancer drug trials
- France – Tramadol et codéine devront être prescrits sur une ordonnance sécurisée
- UK – Sparsentan approved to treat adult patients with primary immunoglobulin A nephropathy (IgAN)
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
- Europe – Leqembi recommended for treatment of early Alzheimer’s disease
- USA – FDA proposes removing oral phenylephrine from use in nasal decongestants
- UK – NHS rolls out ‘stop-smoking’ pill to help tens of thousands quit
- UK – NICE recommends Blueprint Medicines’ Ayvakyt to treat rare blood disorder
- UK – NICE recommends remote monitoring technology for heart failure patients
- France – Mettre à disposition les informations et données autour du médicament aux patients et aux professionnels de santé afin de favoriser un meilleur usage des médicaments
- UK – Pfizer’s Elrexfio recommended by NICE to treat relapsed and refractory multiple myeloma
- Europe – EMA proposes updated guideline on peripheral arterial occlusive disease treatments
- USA – FDA revises more than 800 PSGs in line with ICH M13A
- UK – NICE recommendation for new Alexion PNH treatment
- UK – NICE recommends Santen’s Roclanda to treat glaucoma and ocular hypertension
- UK – AstraZeneca’s Voydeya recommended by NICE to treat rare blood disorder PNH
- UK – Ipsen’s Iqirvo recommended by NICE to treat rare liver disease primary biliary cholangitis
- UK – Eli Lilly’s Alzheimer’s drug Kisunla approved by MHRA but not recommended by NICE
- UK – Merck’s Keytruda recommended by NICE to reduce risk of lung cancer recurrence
- USA – FDA drafts guidance on drug interaction labeling
- UK – Roche’s Alecensa receives NICE recommendation to treat ALK-positive lung cancer
- Europe – Règlement d’exécution (UE) 2024/2699 de la Commission du 18 octobre 2024
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024
- USA – Guidance : Core Patient-Reported Outcomes in Cancer Clinical Trials
- Europe – EMA drafts concept paper for future radiopharmaceuticals guideline
- UK – Johnson & Johnson receives updated NICE recommendation for Tecvayli in multiple myeloma
- Europe – Seizing opportunities in a changing medicines landscape
- France – Wegovy, le médicament vedette contre l’obésité de Novo Nordisk, est lancé en France
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October 2024
- Europe – Improving efficiency of approval process for new medicines in the EU
- UK – NICE Board says new method allowing greater weight to be given to severe diseases is working
- UK – Roche’s injectable C5 inhibitor PiaSky recommended by NICE for rare blood disorder PNH
- Europe – EMA adopts reflection paper on AI/ML in drug development
- USA – FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
- Europe – EMA recommends suspension of sickle cell disease medicine Oxbryta
- USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials
- USA – FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability
- USA – Studies find uneven uptake of biosimilars as availability increases
- Europe – Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
- USA – FDA drafts guidance on multiregional clinical trials in oncology
- USA – FDA updates guidance on classifying ANDA amendments for GDUFA III
- Europe – EMA updates guideline on developing drugs for bipolar disorder
- USA – FDA revises final guidance on nitrosamine impurities
- UK – Relugolix for treating hormone-sensitive prostate cancer
- UK – Emergency kits for people with adrenal insufficiency recommended to avoid hospital admission
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024
- UK – MSD’s Welireg recommended by NICE to treat rare von Hippel-Lindau disease
- UK – Novartis’ Fabhalta recommended by NICE to treat rare blood disorder PNH
- UK – Theramex’s Eladynos recommended by NICE for post-menopausal bone disease
- Europe – EMA guidance document on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare
- Europe – Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
- UK – BeiGene’s Brukinsa recommended by NICE to treat marginal zone lymphoma
- USA – FDA unveils FY 2025 user fee rates
- USA – FDA official clarifies misconceptions around RWE in premarket submissions
- UK – Merck’s Keytruda combination recommended by NICE for advanced gastric cancer
- Europe – Alzheimer : l’Europe dit non au lecanemab… l’Amérique dit oui
- Europe – EMA addendum addresses vaccine development for immunocompromised people
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024
- Europe – EMA advises about risks of using weight loss medicine Mysimba with opioids
- UK – Boehringer Ingelheim’s Metalyse recommended by NICE to treat stroke in adults
- USA – Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
- UK – J&J’s Tecvayli recommended by NICE to treat relapsed and refractory multiple myeloma
- France – Définition des conditions méthodologiques requises pour la prise d’un pari lors d’une demande d’accès précoce pré-AMM ou post-AMM conditionnelle, et sa levée – Note de cadrage
- Europe – Development and manufacture of oligonucleotides – Scientific guideline
- UK – NICE recommends Accord’s oral hormone therapy Orgovyx for advanced prostate cancer
- Europe – EMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024- 2025
- USA – FDA unveils rare disease innovation hub, plans public meeting this fall
- USA – FDA guidance addresses developing treatments for pediatric IBD
- USA – FDA makes exception for antibody drug conjugates in mass balance studies final guidance
- USA – FDA issues final guidance user fees for combination products
- France – Publication et entrée en vigueur de l’annexe 1 des bonnes pratiques de fabrication des médicaments stériles
- Switzerland – Déclarations d’effets indésirables présumés de vaccins contre le COVID-19 évaluées en Suisse
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024
- USA – FDA releases draft guidance on use-related risk analysis for combo products
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024
- USA – FDA drafts guidance on essential outputs for drug delivery devices
- Europe – EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era
- USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
- Europe – Commission authorises Chikungunya vaccine and funds new mosquito eradication programme
- Europe – Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products – Scientific guideline
- Europe – Clinical investigation of recombinant and human plasma-derived factor IX products – Scientific guideline
- Europe – First nasal adrenaline spray for emergency treatment against allergic reactions
- Europe – Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension
- UK – Responding to new final draft guidance from NICE for a new gene therapy for haemophilia B
- Europe – EU actions to tackle shortages of GLP-1 receptor agonists
- Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments
- Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
- USA – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule
- USA – FDA finalizes guidance on drug development for diabetic foot infections
- Europe – Faster access to clinical trial information in Europe
- USA – FDA finalizes guidance giving ANDA facilities time to comply with cGMP
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024
- France – Vaccination maternelle contre le VRS : une nouvelle possibilité pour protéger le nouveau-né
- Europe – Two new advice pilots to improve clinical trials in Europe
- Europe – Annual report 2023
- USA – FDA issues draft guidances covering BIMO inspections
- USA – AAM seeks clarity, leeway in BA/BE studies guidance
- USA – Experts, FDA officials discuss future of clinical trials
- France – Acide hyaluronique : les autorités sanitaires renforcent la réglementation en rendant la prescription médicale obligatoire
- Europe – Procedural advice on paediatric applications
- UK – New restrictions on puberty blockers
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024
- Europe – First vaccine to protect adults from Chikungunya
- Europe – New gene therapy treatment for haemophilia B
- USA – FDA plans to release AI drug development guidance this year
- Europe – Commission approves up to €1 billion of State aid by six Member States for the first Important Project of Common European Interest in the health sector
- Europe – Commission facilitates faster access to medicines with clear rules for joint clinical assessments
- USA – FDA issues platform technology designation draft guidance
- UK – Researchers combine herpes virus with cancer vaccine to treat brain cancer in children
- France – L’ANSM inscrit de nouveaux cannabinoïdes sur la liste des stupéfiants
- USA – Glioblastome : un essai vaccinal prometteur
- Europe – EMA revises Q&A guidance on drug-device combination products
- Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
- USA – Stakeholders provide feedback on FDA draft guidance on drug development for early Alzheimer’s disease
- Europe – Hydroxyprogesterone caproate medicines to be suspended from the EU market
- Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
- USA – FDA unveils draft guidance on REMS logic models
- USA – FDA exploring model master files to expedite generic drug development
- UK – New cabotegravir formulations approved to help prevent HIV-1 infection in adults and adolescents
- USA – Emerging technologies and regulatory agency guidance for CGTs
- USA – FDA drafts two guidances on safety testing for cell and gene therapy products
- USA – FDA issues three guidances to expand cancer clinical trial eligibility
- USA – FDA issues long-awaited LDT final rule
- Europe – Guidance : Anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans (body and Annexes 4 and 6)
- USA – FDA updates guidance on promotional labeling and advertising of biosimilars
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024
- UK – 170,000 people in England to have further treatment choice for preventing migraine attacks.
- UK – Children and teenagers with an aggressive form of brain cancer set to benefit after NICE recommends new life-extending drug combination treatment
- USA – CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated approval guidance
- Europe – EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs
- Europe – New recommendations to strengthen supply chains of critical medicines
- USA – FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
- USA – FDA launches new clinical trial center to improve innovation, communication
- Europe – Parliament adopts its position on EU pharmaceutical reform
- Europe – Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) – Scientific guideline
- USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates – Final Guidance for Industry
- France – Expérimentation du cannabis médical : quelle continuité de la prise en charge ?
- USA – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies: Guidance for Industry
- USA – Center for Drug Evaluation and Research – Office of Pharmaceutical Quality : 2023 Annual Report
- USA – Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks
- USA – FDA turns attention to data integrity lapses at testing sites in new guidance
- USA – FDA finalizes guidance on electronic submission of BA/BE adverse event reports to FAERS
- USA – FDA Approves New Antibiotic for Three Different Uses
- USA – FDA shifts IND safety reporting over to FAERS in finalized guidance
- USA – FDA launches new Quantitative Medicine Center of Excellence
- USA – FDA reduces number of samples to retain for BA/BE testing
- Europe – European Commission proposes updates to medical device phthalates guidelines
- Europe – EU recommendations for 2024/2025 seasonal flu vaccine composition
- New Eealand – New Zealand updates pharmacovigilance guideline
- Europe – EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials
- Europe – EMA Management Board: highlights of March 2024 meeting
- France – Paxlovid (nirmatrelvir/ritonavir) : rappel des interactions médicamenteuses avec certains immunosuppresseurs, notamment le tacrolimus, pouvant être fatales
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024
- Europe – Regulatory requirements for conditional marketing authorization ‘evolving’
- USA – FDA offers guidance on observational studies as RWE
- USA – FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
- USA – FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
- USA – Industry clamors for clarity on FDA’s advanced manufacturing designation program
- Europe – Environmental risk assessment of medicinal products for human use
- Europe – Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
- USA – FDA proposes rule for difficult-to-compound drugs, drug categories
- UK – New treatment option available today for womb cancer
- Europe – EU pharmaceutical policy: MEPs support comprehensive reform
- USA – FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
- Europe – European Parliament committee proposes changes to pharma legislation
- USA – FDA offers guidance on minor label changes for OTC drugs
- Europe – EU regulators and industry clash on pharmaceutical reform package
- Europe – Commission proposes new measures for the better lifecycle management of medicine authorisations
- USA – FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease
- USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer
- Europe – Procedural advice for orphan medicinal product designation
- France – Forfait innovation : une 1ère technologie de santé inscrite au remboursement par l’Assurance maladie
- Europe – European Commission proposes framework for joint clinical assessments
- UK – UK’s MHRA approves first drug under international recognition procedure
- USA – Cell therapy equipment: regulatory guidelines and feedback opportunities
- USA – FDA updates early Alzheimer’s drug development guidance to add support for biomarkers, surrogate endpoints
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024
- France – La HAS actualise la stratégie de vaccination contre le zona
- Europe – DARWIN EU® continues expanding its capacity to deliver real-world data studies
- Switzerland – Nouvelles autorisations de médicaments complémentaires et de phytomédicaments
- France – Cannabis médical : point d’étape sur la dernière année de l’expérimentation et l’arrivée de médicaments à base de cannabis
- USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry
- USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy, and more
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024
- USA – Industry urges FDA to do more to help companies prepare for DSCSA
- UK – Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata
- USA – FDA warns industry about potential data integrity issues with third-party labs
- Europe – EMA proposes new guideline on non-inferiority trials
- Switzerland – Swiss Medtech soutient les négociations concernant un paquet d’accords bilatéraux lll
- USA – FDA finalizes guidance on charging for investigational drugs
- USA – FDA issues new draft guidance on data monitoring committees
- Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
- Europe – Evaluation of medicinal products indicated for treatment of bacterial infections
- UK – NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024
- Europe – Progress update on pilot for academic and non-profit developers of advanced therapy medicines
- UK – Brainomix’s AI-enabled stroke software endorsed by NICE
- UK – Illegal medicines worth more than £30 million seized in the UK in 2023
- UK – Updated NICE guidance recommends more targeting of antibiotics to those at the highest risk of suspected sepsis
- USA – FDA modernizing pharmacovigilance oversight with AI tools
- USA – FDA finalizes best practices guide for postmarketing safety studies
- Europe – EMA proposes waiving comparative efficacy studies for certain biosimilars
- Europe – Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
- USA – Clinical trials: FDA proposes new standards for collecting race, ethnicity data
- UK – Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas
- USA – FDA issues QMSR final rule with 2-year transition period
- Europe – Clinical trials’ transition to new EU system – one year left
- USA – FDA: Genome editing therapies may use accelerated approval pathway
- Europe – Experts outline challenges of combination products in Europe
- USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety prob
- USA – FDA updates guidance on remote regulatory assessments
- Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024
- Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
- Europe – EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
- USA – FDA final guidances aim to streamline ANDA reviews
- UK – NICE recommends two AI-powered software tools for stroke diagnosis in NHS
- Europe – User guide for micro, small and medium-sized enterprises
- USA – Growing interest in modeling prompts launch of MIE program for generic drugs
- UK – MHRA introduces new restrictions for fluoroquinolone antibiotics
- UK – Pfizer’s Talzenna recommended by NICE for advanced breast cancer
- France – Essais cliniques de médicaments : toutes les demandes de transition doivent être déposées sur le portail CTIS
- Europe – Human medicines: highlights of 2023
- Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
- UK – Pfizer’s COVID-19 antiviral Paxlovid recommended by NICE for expanded use
- Europe – Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
- USA – FDA updates draft guidance on division-level ANDA disputes
- Europe – EMA explains how tweaked Brexit deal will affect medicinal products
- USA – FDA issues final guidance on rare disease drug development
- USA – Novel Drug Approvals for 2023
- USA – Industry groups seek changes to FDA’s remote interactive evaluation guidance
- USA – FDA CGT draft guidance focuses on potency assurance strategy
- USA – FDA adds microbiological assessments to ophthalmic drug quality guidance
- USA – FDA issues final guidance on major statement in DTC ads
- USA – FDA finalizes guidance to limit use of benzene in drug products
- Canada – Notice – Implementation of ICH E19: A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
- USA – FDA proposes master control trial guidance that goes beyond COVID-19
- USA – Stakeholders concerned with FDA’s definition of labeling in PDURS guidance
- USA – FDA finalizes guidances on RWD in regulatory submissions, assessing registries
- UK – AstraZeneca/Merck’s Lynparza recommended by NICE for advanced prostate cancer
- USA – FDA proposes updated medtech RWE guidance
- Brazil – ANVISA approves skinny labeling in Brazil
- Europe – EU agencies adopt workplan on AI in medicines regulation
- USA – FDA establishes advisory committee for genetic metabolic disease treatments
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023
- USA – FDA guidance details new advanced manufacturing technology designation program
- USA – Experts discuss red flags that can trigger legal action against drug and device makers
- Europe – First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
- Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines
- USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR and LDT rules
- USA – FDA finalizes guidance on DSCSA verification systems
- UK – AstraZeneca/Merck’s Lynparza combination recommended by NICE for advanced ovarian cancer
- USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
- France – L’agence du médicament sonne l’alarme au sujet de réactions allergiques associées à un antiseptique
- USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
- USA – Combination products: Non-harmonized regulations are hurting manufacturers
- UK – Pfizer’s RSV vaccine granted MHRA approval to protect infants and older adults
- USA – FDA outlines process for recognizing standards for regenerative medicines
- UK – MHRA instructs health organisations to prepare now for new measures to reduce ongoing serious harms of valproate
- Europe – Pharma groups fight proposed ban on titanium dioxide in Europe
- UK – AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in infants
- USA – Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling
- USA – FDA issues new standards for DTC prescription drug ads
- USA – Global Pharma’s eye drops contaminated with “filth” while Amazon made unapproved claims for eye drops
- USA – Industry calls for revisions in FDA’s CGT manufacturing change guidance
- UK – MHRA authorises world-first gene therapy for two inherited blood disorders
- France – Levothyrox et médicaments à base de lévothyroxine : information concernant la disponibilité d’Euthyrox
- France – Trois bases de données médicamenteuses obtiennent l’agrément version 3 de la HAS
- Europe – EMA seeks feedback on clinical development of vaccines for immunocompromised people
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023
- UK – NICE recommends Chiesi’s alpha-mannosidosis enzyme replacement therapy
- USA – FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus
- USA – FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
- Europe – First electronic product information (ePI) published for selected human medicines
- USA – FDA finalizes guidance on real-time review of oncology drugs
- UK – MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post-menopausal women
- USA – FDA publishes two guidances on collecting clinical outcomes data
- USA – FDA moving in the right direction with psychedelic drug guidance
- USA – FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas
- USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing
- USA – FDA won’t extend LDT rule comment period
- Europe – EMA encourages companies to submit type I variations for 2023 in November 2023
- USA – FDA expands KASA review program to drug substances
- Europe – EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
- USA – FDA expands scope of off-label guidance to include presentations from reprints
- USA – Dems urge free OTC birth control while GOP fights to ban mail-order abortion pill
- Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
- UK – Novartis’ Cosentyx recommended by NICE for hidradenitis suppurativa
- USA – FDA addresses use of remote interactive evaluations in post-pandemic era
- Europe – EMA takes further steps to address critical shortages of medicines in the EU
- USA – FDA finalizes guidance on considerations for evaluating drug’s benefits and risks
- Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens
- UK – NICE recommends Roche’s Columvi for advanced lymphoma in UK
- France – FDA guidance calls for testing all alcohol-based products for methanol
- USA – FDA offers guidance on development of antimicrobials for diabetic foot infections
- USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2023
- UK – Guidance : Full pack dispensing of valproate-containing medicines
- Latin America – Brazil, Mexico launch efforts to ease biosimilar regulation
- Europe – Convergence: EMA official urges transition of existing clinical trials to CTIS portal
- USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
- USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
- USA – FDA offers first guidance on stimulant use disorder drug development
- Europe – EMA Management Board: highlights of October 2023 meeting
- USA – FDA updates policies for reviewing ANDAs
- USA – FDA finalizes guidance on dose banding for injectables
- USA – FDA guidance explores trial design, supporting data for GVHD treatments
- USA – FDA adds breakpoint updates to antimicrobial susceptibility test system device labeling guidance
- Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
- France – Chimiothérapies par fluoropyrimidines (5-FU) : l’Institut et la HAS actualisent leurs recommandations sur la recherche du déficit en enzyme DPD
- Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS ban
- USA – CBER revises internal procedures for processing clinical holds, NDAs and BLAs
- Europe – Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs a year, report claims
- Switzerland – Swissmedic updates adverse event reporting requirements for 2024
- UK – Guidance : Drug Safety Update: monthly PDF newsletter
- UK – NICE nod for Darzalex with lenalidomide and dexamethasone
- USA – FDA guidances keep coming, new device harmonization plan, and more
- USA – FDA releases guidance on labeling of drug use-related software outputs
- Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
- USA – FDA guidance on conducting trials during emergencies shifts away from COVID-19
- UK – COVID-19: guidance for people whose immune system means they are at higher risk
- UK – NICE recommends more genetic testing for links to ovarian cancer
- USA – FDA expands types of acceptable confirmatory evidence in new guidance
- France – Médicaments à base de miansérine : rappel du bon usage et des risques d’effets indésirables graves notamment chez les patients âgés
- USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels
- UK- Pfizer’s Vydura recommended by NICE for acute migraines
- France – La campagne de vaccination contre le Covid-19 avancée au 2 octobre alors que la circulation du virus augmente en France
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023
- France – L’ANSM classe plusieurs vaccins sur la liste I des substances vénéneuses
- Europe – EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
- Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
- USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug products
- Europe – Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
- USA – FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
- UK – Eli Lilly’s Mounjaro receives NICE recommendation to treat type 2 diabetes
- UK – NICE issues two recommendations for UCB’s inflammatory disease drug
- France – Vaccination contre le Covid-19 et maternité
- New Zealand – Guidelines on the Regulation of Therapeutic Products in New Zealand
- USA – FDA finalizes guidance on use of human factors studies in combination product development
- USA – FDA draft guidance focuses on postapproval trial diversity data
- USA – FDA finalizes guidance on standards for tracing products through supply chain
- USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III
- UK – MHRA approves Pfizer/BioNTech’s adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5
- UK – Guidance published on the new international regulatory recognition routes for medicines approvals
- UK – NICE recommends Chiesi’s Elfabrio for adults with Fabry disease
- USA – FDA publishes additional guidances on delay of enforcing DSCSA electronic tracking requirements
- Europe – PRAC recommends new measures to avoid topiramate exposure in pregnancy
- Europe – COVID-19: Commission authorises adapted COVID-19 vaccine for Member States’ autumn vaccination campaigns
- USA – FDA finalizes guidance on real-world evidence in drug approvals
- Europe – Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
- UK – NHS world first rollout of cancer jab that cuts treatment time by up to 75%
- USA – Psychedelic drug trial guidance: Commenters see vital role for psychotherapy
- UK – Nitrosamines impurities in medicines
- UK – NICE recommends Amryt’s Filsuvez for rare skin disorder
- USA – FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
- USA – Bacterial endotoxin testing of drugs and biologics in the US: Ensuring patient safety
- UK – NICE gives green light for MSD’s Keytruda
- Europe – EMA review of data on paternal exposure to valproate
- USA – FDA issues final guidance on obtaining informed consent in drug and device clinical trials
- USA – FDA drafts guidance on classification category for biosimilar supplements
- Europe – Revocation of authorisation for sickle cell disease medicine Adakveo
- USA – QTc: FDA proposes labeling for heart drugs with heart rhythm risk
- USA – FDA sets acceptable intake limits for nitrosamines in drugs
- USA – FDA finalizes guidance on DSCSA waivers, exceptions and exemptions
- USA – Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance
- Europe – EMA updates Q&A document on publication of clinical trial data
- Canada – Notice: Release of (Step 4) ICH S12 Guideline – Nonclinical Biodistribution Considerations for Gene Therapy Products
- UK – NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy
- USA – FDA approves second over-the-counter naloxone nasal spray for opioid overdose
- USA – Pharmaceutical distributors seek two-year delay in DSCSA tracking rules
- USA – Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda
- USA – FDA finalizes guidance on drug quality consensus standards recognition program
- Europe – Paving the way towards coordinated clinical trials in public health emergencies in the EU
- Europe – Review: real-world data studies
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023
- Europe – First RSV vaccine to protect infants up to 6 months of age and older adults
- Europe – Reflection paper on the use of artificial intelligence in the lifecycle of medicines
- France – Traitement de l’acné sévère : mieux faire connaître les risques associés à l’isotrétinoïne orale
- USA – FDA issues draft guidance on reporting manufacturing changes for gene therapies
- USA – FDA Approves New Drug to Prevent RSV in Babies and Toddlers
- USA – FDA revises IEM drug draft guidance to clarify food standards, use of control groups
- Europe – European Health Union: EU steps up action to prevent shortages of antibiotics for next winter
- USA – FDA Approves First Nonprescription Daily Oral Contraceptive
- USA – Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
- USA – Postmarketing requirements: FDA drafts guidance on determining non-compliance
- Europe – EMA statement on ongoing review of GLP-1 receptor agonists
- USA – FDA describes agency’s initiatives to accommodate growth in cell and gene therapy fields
- France – Stratégie de vaccination contre la Covid-19 : actualisation des recommandations relatives à l’administration concomitante des vaccins contre la Covid-19 et contre la grippe saisonnière
- USA – Stakeholders want consistency, more examples in last FDA draft guidance on patient-focused drug development
- UK – Novavax COVID-19 vaccine produces immunity
- Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
- Europe – Clinical Trials Information System (CTIS) – Sponsor Handbook
- Australia – Nitrosamine risk assessment in Category 1 prescription medicine registration applications
- Europe – Phasing out of extraordinary COVID-19 regulatory flexibilities
- Europe – Global regulators confirm good safety profile of COVID-19 vaccines
- UK – BMS’ Sotyktu gets NICE green light for NHS use
- France – Clomid (citrate de clomifène) : le traitement doit être arrêté en cas d’altération de la vision
- Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus
- USA – FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
- USA – FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional labeling, ads
- USA – FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine
- UK – Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis
- Europe – Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations
- Europe – Use of real-world evidence in regulatory decision making – EMA publishes review of its studies
- USA – FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
- Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023
- USA – Pharmacogenomic data guidance: Industry objects to reporting exploratory studies
- USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022
- Europe – ACT EU: creating a better environment for clinical trials through collaboration
- USA – FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy
- USA – Generic drug lobby details extent of US shortages, offers possible solutions
- Europe – Report: How EU ensured safety of medicines during COVID-19
- USA – FDA pilot aims to boost transparency for oncology tests
- USA – FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
- USA – FDA details policy on facility reclassification requests under GDUFA III
- Catégorie : International
- International – ICH releases guidelines on developing medicines for pregnant population and quality information in CTD
- International – Press Release: ICH Assembly Meeting, Madrid, Spain, May 2025
- International – International group proposes best practices for AI in pharmacovigilance
- UK – BMS receives NICE recommendation for immunotherapy combination in colorectal cancer
- International – ICH releases overhauled stability guideline for consultation
- International – Clinical Trials Information System designated as WHO primary registry
- International – WHO adds first maternal RSV vaccine to prequalification list
- International – Health agencies recommend best practices for using surrogate endpoints
- International – WHO guideline aims to facilitate the development of “more durable” pediatric medicines
- International – ICH adopts E6(R3) guideline on good clinical practices
- Europe – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
- International – Mpox : l’OMS approuve un second vaccin, fabriqué par une société pharmaceutique japonaise
- International – Industry stakeholders call for changes to ICH M14 RWD guideline
- India – National Regulatory Authority of India meets WHO international standards for vaccine regulations
- International – The ICH E11A Guideline reaches Step 4 of the ICH Process
- International – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
- International – VIH : un médicament préventif efficace, avec deux injections par an seulement, suscite l’enthousiasme
- International – WHO publishes guidance for HPV vaccine developers to help tackle cervical cancer
- International – ICH announces forthcoming documents on nitrosamine impurities, RWD
- International – ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance on RWD
- International – WHO recommends risk management plans for high-risk excipients
- International – WHO issues guidance on nitrosamine controls in drug manufacturing
- International – ICH M13A BE testing guideline expected to be adopted this summer
- International – ICH E2D(R1) Guideline on post-approval safety data: definitions and standards for management and reporting of individual case safety reports Step 2b
- International – ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management »
- International – ICH targets cell and gene therapies, real-world data as topics ripe for harmonization
- International – ICH consults on revised post-approval safety guideline that accounts for digital platforms
- International – Regulators, industry tout new approach for benefits-risk assessments
- International – ICH Q14 Analytical procedure development – Scientific guideline
- International – ICH Q2(R2) Validation of analytical procedures – Scientific guideline
- International – WHO decision improves children’s access to safer polio vaccine
- International – The subjectivity of starting materials in the era of harmonization
- International – ICH adopts guidelines on viral safety evaluation and analytical method development
- International – ICH releases Q9 training materials on quality risk management
- International – WHO releases key regulatory considerations on AI for health
- International – Convergence: Confusion lingers over interchangeability and switching of biosimilars
- International – The WHO anatomical therapeutic chemical/defined daily dose toolkit
- International – E-labeling and digital transformation in healthcare
- International – FDA announces completion of first joint assessment with EMA in ICMRA pilot
- International – WHO proposes best practices for clinical trials
- International – WHO seeks to align biowaiver policy with ICH guidelines
- International – ICH paper calls for ‘stepwise’ harmonization of RWE
- International – ICH charts new topics, touts progress in updating existing guidelines
- International – Genetically altered vaccines developed to help eradicate polio
- Catégorie : France
- Catégorie : Europe
- Catégorie : Amériques
- Catégorie : Asie-Pacifique
- Catégorie : Découverte
- Catégorie : Cosmétiques
- Catégorie : Cosmétiques France
- Catégorie : Cosmétiques Europe
- Catégorie : Cosmétiques International
- Catégorie : Santé Publique
- Europe – 2024 annual report is published
- USA – Judge rules J&J unit must pay $442M in antitrust case
- International – « Face à la pression de l’administration Trump sur l’industrie pharmaceutique, il faut anticiper une flambée des prix des médicaments »
- France – Vaccination contre les papillomavirus : élargissement de la cohorte de rattrapage vaccinal chez les hommes et les femmes jusqu’à 26 ans révolus
- International – Chikungunya : Mayotte est passée en phase d’épidémie, annonce Santé publique France
- France – Androcur : « C’est une grosse étape de franchie », réagit Véronique, reconnue victime des laboratoires Bayer, Sandoz et Viatris
- France – Levothyrox : l’Agence nationale du médicament, mise en examen pour « tromperie », se pourvoit en cassation
- France – Analyse des déclarations des évènements indésirables graves associés aux soins (EIGS) survenus chez les nouveau-nés
- France – Mieux prévenir et gérer les événements indésirables graves associés aux soins survenant chez les nouveau-nés
- USA – Une étude américaine révèle que le vapotage double le risque de maladies pulmonaires graves, même sans antécédents de tabagisme
- International – World Health Assembly adopts historic Pandemic Agreement to make the world more equitable and safer from future pandemics
- International – Chikungunya : les autorités redoutent l’importation de l’épidémie en métropole
- France – Papillomavirus (HPV) : le rattrapage vaccinal recommandé chez les femmes et les hommes jusqu’à 26 ans révolus
- France – Levothyrox : retour en 8 actes sur cette affaire opposant plusieurs milliers de patients au laboratoire allemand Merck
- France – Infections invasives à méningocoques à Rennes : les autorités sanitaires rappellent l’importance de la vaccination pour les 15-24 ans
- France – Levothyrox. Confirmation de la mise en examen de Merck et de l’ANSM pour tromperie aggravée : « ce que j’ai vécu, c’est comme un empoisonnement »
- France – Le « proto », des cas d’intoxication toujours en augmentation
- International – Chikungunya : six morts liés à l’épidémie recensés à La Réunion depuis le début de 2025
- International – Les États Membres de l’OMS concluent les négociations et réalisent des progrès significatifs sur le projet d’accord sur les pandémies
- UK – UK clinical trials regulations signed into law
- France – Rapport d’activité 2024 de la HAS
- France – Le gouvernement salue la qualité du rapport de Stéphanie Rist et décline ses priorités pour accompagner les femmes en prévention de la ménopause
- France – L’ANSM lance une campagne de sensibilisation au bon usage des médicaments dans le traitement de l’anxiété et de l’insomnie
- France – L’IA en santé, un enjeu majeur pour la HAS et l’ensemble du système de santé
- International – Au Mexique, une fille de 3 ans meurt de la grippe aviaire H5N1
- France – Grippe aviaire H5N1 : stratégie vaccinale face à d’éventuels cas chez les personnes au contact d’animaux infectés
- USA – Rougeole aux Etats-Unis : un deuxième enfant est mort au Texas, la gestion de l’épidémie critiquée
- France – Tout ce qui change à compter d’avril 2025 en matière de santé publié le31.03.25
- France – Endométriose : des avancées concrètes et de nouvelles mesures fortes annoncées par le Gouvernement
- France – Plan hivernal : point de situation sur l’approvisionnement de certains médicaments majeurs de l’hiver
- France – Cannabis thérapeutique : le gouvernement avance vers une généralisation en France
- France – Pénuries de médicaments et dispositifs médicaux : le Gouvernement poursuit ses actions pour garantir l’accès aux soins et la disponibilité des produits de santé
- Europe – Unregulated advanced therapy medicinal products pose serious risks to health
- Europe – Règlement (UE) 2025/327 du Parlement Européen et du Conseil du 11 février 2025 relatif à l’espace européen des données de santé et modifiant la directive 2011/24/UE et le règlement (UE) 2024/2847
- International – Un Australien devient le tout premier patient à quitter l’hôpital avec un cœur en titane
- France – Mélanger CBD et médicaments, ce n’est jamais anodin
- International – Rougeole aux Etats-Unis : les autorités sanitaires s’inquiètent d’une étendue de l’épidémie
- France – Des pratiques illégales d’injection de toxine botulinique mettent en danger les utilisateurs
- France – Méningite : cent mille jeunes concernés par une campagne de vaccination dans la métropole rennaise
- France – Ségur numérique et Mon espace santé : lancement de la vague 2 pour l’imagerie médicale et la médecine de ville
- USA – Un enfant est mort de la rougeole aux Etats-Unis, premier décès enregistré en près de dix ans
- USA – FDA : Avoid Dangerous HCG Diet Products
- USA – L’Etat de New York poursuit l’industrie des cigarettes électroniques, accusée de nourrir une « épidémie de vapotage » chez les jeunes
- France – Philip Morris France condamné à 500 000 euros d’amende pour publicité illégale
- France – Paracétamol : attention aux intoxications volontaires par des enfants et des adolescents
- France – Respirateurs Philips : l’agence du médicament autorise le groupe à reprendre la vente en France
- USA – RFK Jr. confirmed as HHS secretary
- France – Interdiction des puffs : un tournant pour la santé et l’environnement
- France – La HAS adopte son nouveau programme « santé mentale et psychiatrie » 2025-2030
- France – Maladie de Charcot : le Parlement adopte une amélioration de la prise en charge
- International – L’Argentine annonce se retirer de l’OMS, jugée « néfaste »
- France – La HAS dévoile son projet stratégique 2025-2030
- UK – World-leading AI trial to tackle breast cancer launched
- France – Les vaccins anti-Covid sont sûrs, réaffirme l’agence du médicament après 152 millions d’injections en France
- International – En Ouganda, une épidémie d’Ebola fait un premier mort depuis 2022
- France – Grippe : l’épidémie s’accélère encore en France, les enfants exceptionnellement touchés
- France – Désinformation médicale: l’ordre des médecins édite une charte pour les créateurs de contenus en ligne
- France – Scandale sanitaire : un médicament contre la maladie de Parkinson qui rend fou
- USA – Donald Trump signe un décret visant les traitements de transition de genre de mineurs
- USA – FDA webpages on clinical trial diversity removed after Trump orders
- France – Le dérapage inéluctable du budget de la « Sécu »
- USA – Experts: Trump executive orders create foundation for what’s to come
- International – WHO urges US to ‘reconsider’ withdrawal from global health organisation
- USA – Sara Brenner named acting FDA commissioner
- USA – L’Organisation mondiale de la santé déstabilisée par le retrait américain
- France – Dépakine : la justice confirme que l’Etat est en partie responsable
- USA – FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy
- France – « Cash Investigation ». Pénuries de médicaments : les labos font-ils la loi ?
- France – Mpox : un premier cas du nouveau variant identifié en France
- France – Hausse des cas de scorbut chez les enfants en France : un « symbole de l’augmentation de la précarité alimentaire »
- France – Cannabis thérapeutique : l’autorisation de prescription pourrait s’arrêter le 31 décembre
- France – Informatique en santé: l’identifiant national de santé devient l’identité nationale de santé (INS)
- France – Un nouveau carnet de santé pour les enfants lancé le 1ᵉʳ janvier, évoquant l’usage des écrans
- France – Dépakine : l’Agence du médicament renforce les restrictions pour la délivrance de médicaments anti-épileptiques
- France – Covid-19 : une étude fondatrice défendue par Didier Raoult sur l’usage de l’hydroxychloroquine invalidée
- Espagne – Le syndrome du loup-garou détecté chez plusieurs bébés à cause d’un médicament populaire contre la calvitie
- France – Fin de la vente libre de huit médicaments antirhume en pharmacie, dont Actifed Rhume, Humex, RhinAdvil ou Dolirhume
- International – Mpox : les efforts commencent à « porter leurs fruits », malgré près de 60 000 cas enregistrés en Afrique
- France – Motions de censure : que se passerait-il sans budget de la Sécurité sociale ?
- France – Données de santé : une nouvelle application de Doctolib fait débat
- Europe – European Shortages Monitoring Platform enables better monitoring of shortages in the EU
- France – Médicaments : malgré une efficacité douteuse, le Spasfon reste une passion française
- France – Dolirhume, Actifed, Humex, Rhinadvil… Pourquoi certains médicaments contre le rhume posent problème ?
- France – La baisse du remboursement de certains médicaments par la « Sécu », un choc pour toute la chaîne de la santé
- Europe – New chair of the MHRA
- Europe – Antimicrobial Resistance : A call to action against the silent pandemic
- France – La HAS chargée de structurer la posologie des médicaments pour mieux sécuriser les e-prescriptions
- France – Doliprane, Dafalgan, Ventoline ou Spasfon : l’Assurance-maladie livre son palmarès des médicaments remboursés les plus consommés en France
- France – De nouveaux membres pour la commission de la transparence (CT) et la commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS)
- International – WHO announces priority endemic pathogens for urgent vaccine development
- France – Androcur : une plainte déposée par les victimes du médicament pour mise en danger d’autrui et tromperie aggravée
- France – Catherine Paugam-Burtz nommée directrice générale de l’ANSM
- France – L’AIS et la HAS signent une charte de coopération
- UK – UK to create world-first ‘early warning system’ for pandemics
- UK – Smoking ban introduced to protect children and most vulnerable
- Europe – Fostering regulatory collaboration to improve access to mpox medicines
- Europe – Virus mpox : un premier cas du nouveau variant confirmé en Allemagne
- International – Egypt is certified malaria-free by WHO
- France – Questions/Réponses – Vaccination grippe saisonnière et COVID-19
- France – Le Clusif et l’AFCDP publient un nouveau guide sur le traitement des données de santé
- USA – FDA issues emergency compounding guidance to address drug shortages due to recent hurricanes
- France – Doliprane : des politiques de tous bords demandent au gouvernement d’empêcher la cession de la filiale de Sanofi à un fonds américain
- Europe – Overcoming the COVID-19 pandemic together and building a Health Union
- France – Projet de loi de financement de la sécurité sociale pour 2025
- International – Diabète de type 1 : des cellules souches reprogrammées ont permis de « guérir » une patiente
- France – L’épidémie de Covid-19 connaît un regain, sans « aucun signal inquiétant », selon les experts
- France – Didier Raoult interdit d’exercer la médecine durant deux ans
- France – Tramadol et codéine devront être prescrits sur une ordonnance sécurisée dès le 1er décembre
- France – Pénuries de médicaments : 8 millions d’euros d’amendes pour 11 laboratoires pharmaceutiques
- International – Covid-19 : une étude précise la présence à Wuhan, en 2019, d’animaux potentiellement vecteurs du SARS-CoV-2
- International – WHO adds first mpox vaccine to prequalification list
- France – Moustique-tigre : un « risque assez élevé » d’épidémies en France dans les cinq prochaines années, alerte l’Anses
- International – WHO issues guideline to curb antibiotic pollution
- France – Dépakine : Sanofi condamné à indemniser la lanceuse d’alerte Marine Martin après douze ans de procédure
- France – Covid-19 : une nouvelle publication du professeur Didier Raoult signalée aux autorités de santé
- Europe – Harnessing AI in medicines regulation: use of large language models (LLMs)
- UK – Revised recommendations for the prevention of secondary Haemophilus influenzae type b (Hib) disease
- France – Les autorités sanitaires renforcent la stratégie vaccinale de lutte contre le mpox
- USA – Un outil numérique de messagerie a augmenté l’arrêt du vapotage chez des adolescents américains
- UK – MHRA finds evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal and self-injurious thoughts and actions
- France – Mpox (MPXV) : la HAS actualise ses recommandations vaccinales pour mieux lutter contre la circulation du virus
- France – Microbiote : Une bactérie intestinale responsable d’une maladie auto-immune
- USA – FDA warns Walmart, Amazon, and other retailers over unapproved skin peel products
- USA – FDA dings Kaleo over Instagram post with insufficient risk information
- France – Nouvelle réglementation européenne sur les substances d’origine humaine (SoHO)
- USA – Lait pour prématurés : aux Etats-Unis, les laboratoires pharmaceutiques Abbott condamnés à payer 495 millions de dollars
- France – Budget de la « Sécu » : une préparation tronquée, un cap politique en suspens
- France – Le gouvernement interdit Sniffy, une poudre énergisante à inhaler par le nez
- France – La HAS répond au droit d’alerte sur la prise en charge des effets indésirables liés aux fluoroquinolones
- France – Recrudescence de la coqueluche : la HAS renforce les recommandations vaccinales pour protéger les nouveau-nés et les nourrissons
- Europe – Ph. Eur. bids adieu to rabbit pyrogen test in its monographs
- International – Le Covid-19 tue encore environ 1 700 personnes par semaine dans le monde, selon l’OMS
- Europe – EMA’s safety committee elects new chair
- France – La HAS propose l’extension du dépistage néonatal à l’amyotrophie spinale
- France – Les autorités de santé alertent sur la circulation croissante d’opioïdes de synthèse, dont une nouvelle classe particulièrement dangereuse, désormais inscrite sur la liste des stupéfiants
- France – Un cas autochtone de dengue signalé pour la première fois de l’année en France, dans l’Hérault
- France – Stratégie vaccinale de prévention des infections par le VRS chez l’adulte âgé de 60 ans et plus
- Europe – Canada joins Horizon Europe programme
- France – Doctolib teste un « assistant de consultation » doté d’intelligence artificielle
- Africa – Variole du singe : une nouvelle souche plus dangereuse apparue en RDC inquiète l’OMS et les chercheurs
- UK – NICE and NHS England announce plan to enable innovative tech to be adopted quicker
- UK – New pregnancy prevention measures introduced for topiramate
- France – Covid-19 : une circulation virale accrue, boostée par le nouveau sous-variant KP.2
- France – Les pharmaciens vont pouvoir prescrire des antibiotiques sans ordonnance pour des angines et cystites
- International – La grippe aviaire de type H5N2 fait sa première victime humaine, rapporte l’Organisation mondiale de la santé
- International – « Il est urgent d’harmoniser les réglementations internationales de biosécurité dans la recherche »
- International – Le Rwanda se positionne en futur hub régional de la production de vaccins ARN messager
- France – Label « Prise en charge de la douleur de l’accouchement : analgésie périmédullaire et alternatives médicamenteuses » – Note de cadrage
- France – Grossesse et VIH : désir d’enfant, soins de la femme enceinte et prévention de la transmission mère-enfant
- Europe – Annual report highlights progress in science, medicines and health in 2023
- France – Sécurité sociale : en 2024, le déficit pourrait être supérieur de 6 milliards d’euros aux prévisions
- UK – Sang contaminé au Royaume-Uni : pourquoi le scandale n’est-il reconnu que maintenant ?
- France – Le Sénat pose des interdictions à la prise en charge médicale des mineurs transgenres
- France – Comprendre la polémique autour de « Sniffy », la poudre blanche énergisante à inhaler par le nez
- France – Christelle Ratignier-Carbonneil quitte la direction de l’Agence nationale de sécurité du médicament
- International – Study finds link between malaria parasites developing antimalarial drug resistance
- Europe – Le nombre de cas de coqueluche en forte augmentation en Europe
- Europe – European medicines network designated as WHO listed authority
- UK – Pharmacists who illegally supplied more than 55 million doses of controlled drugs sentenced
- France – Défaut d’impression de quelques pipettes graduées de Doliprane 2,4 % suspension buvable : vérifiez les pipettes dans vos boîtes
- France – Le Centre de crises sanitaires du ministère chargé de la santé
- France – Mise à jour des référentiels santé: la Cnil ouvrira une consultation le 16 mai
- UK – New 5-year plan to combat antimicrobial resistance
- USA – Le gouvernement américain sur le point de classer le cannabis comme une drogue moins dangereuse
- Europe – ETF recommends updating COVID-19 vaccines to target new JN.1 variant
- International – Talc et cancer : Johnson & Johnson prêt à débourser 6,5 milliards de dollars pour clore les poursuites
- International – Respirateurs Philips défectueux : la marque accepte de payer 1,1 milliard de dollars après des plaintes aux Etats-Unis
- International – Confidentiality arrangement between the EU and the Republic of Korea
- International – Choléra : Mayotte se prépare à devoir faire face à une épidémie
- France – Méningite : la vaccination obligatoire pour les bébés sera élargie à partir du début de 2025
- Europe – EU Health Data Space: more efficient treatments and life-saving research
- France – Nestlé contraint de détruire deux millions de bouteilles de Perrier après une contamination bactérienne
- International – Les vaccins ont permis de sauver 154 millions de vies depuis cinquante ans, selon l’OMS
- Europe – L’UE ouvre une enquête sur les marchés publics chinois de dispositifs médicaux
- France – Retrait d’un vaccin antigrippal en raison d’un bras de fer tarifaire entre Sanofi et les autorités sanitaires
- France – Le moustique tigre : une implantation dans 78 départements en métropole
- France – « Décennie numérique »: la France fixe l’objectif que « 100% des citoyens de l’UE » aient accès à leur dossier médical électronique en 2030
- UK – Study reveals how specific nasal cells protect against COVID-19 in paediatric patients
- France – Scandale du Levothyrox : une nouvelle étude menée en partie par des chercheurs toulousains charge le fabricant Merck
- International – COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements
- USA – Court orders Philips to stop CPAP, BiPAP, ventilator production
- France – Tramadol : moins de comprimés dans les boîtes pour un meilleur usage
- France – Cannabis : « Le moment est venu de débattre de la meilleure manière de réguler le marché dans un cadre légal »
- France – Défaut du code-barre datamatrix sur certaines boîtes de Dépakine 500 mg chrono
- France – Interdiction au 2 avril 2024 de la publicité auprès du grand public pour l’ibuprofène 400 mg
- France – Infections invasives à méningocoques : des recommandations vaccinales actualisées
- International – Prévention des pandémies : les pays membres de l’OMS n’ont pas réussi à conclure un accord international
- UK – The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect
- France – Cancer du sein : une piste pour bloquer la formation de métastases
- France – Recommandations relatives aux lieux et conditions d’environnement pour la réalisation d’une téléconsultation ou d’un télésoin
- Europe – Le Parlement trouve un accord sur l’interdiction des cigarettes électroniques jetables puffs
- Japan – La propagation rapide d’une infection bactérienne grave inquiète le Japon
- France – Deux nominations à la HAS
- UK – Disgraced company director convicted of falsifying medicine quality data
- UK – Researchers reveal COVID-19 could have small impacts on cognition and memory
- USA – Aux Etats-Unis, les républicains embarrassés par la décision de l’Alabama de considérer les embryons congelés comme des enfants
- UK – First UK patients receive experimental mRNA therapy for cancer in global trial
- Brazil – Le Brésil menacé par une épidémie de dengue sans précédent
- France – Expérimentation par la HAS de la méthode de labellisation d’indicateurs conçus par des organismes externes pour l’amélioration de la qualité et de la sécurité des soins à partir de 2024
- France – Interdiction de la publicité auprès du grand public pour l’ibuprofène 400 mg
- France – Papillomavirus : l’intérêt de vacciner jusqu’à 26 ans pour prévenir le cancer du col de l’utérus débattu
- France – Vitiligo : un premier traitement disponible en France
- France – Nestlé reconnaît avoir eu recours à des traitements interdits sur des eaux minérales pour maintenir leur « sécurité alimentaire »
- France – Stratégie française en santé mondiale (2023-2027)
- USA – Johnson & Johnson agrees $700m settlement to resolve talcum powder investigations
- France – La HAS a adopté le référentiel d’agrément des sociétés de téléconsultation
- France – Innovation médicale : Franck Zal et son ver marin des plages bretonnes remportent le prix Galien
- France – Lionel Collet nomme Jean Lessi à la direction générale de la HAS
- USA – FDA considers issuing more final guidances without comment period
- USA – GOP lawmakers prod FDA over internal scientific disputes resolution process
- France – Lionel Collet nomme Jean Lessi à la direction générale de la HAS
- France – Procès du Mediator : Servier condamné en appel à rembourser plus de 415 millions aux organismes de Sécurité sociale
- France – Progestatifs et risque de méningiome : recommandations pour limiter ce risque
- France – « La PMA est une médecine hasardeuse en l’absence de diagnostic préimplantatoire »
- International – Variole du singe : l’OMS craint que l’épidémie ne se propage dans le monde depuis la RDC
- UK – Physical activity could reduce breast cancer risk in women before menopause
- Europe – La Commission européenne et l’OMS souhaitent développer l’interopérabilité des données de santé
- France – Numérique en santé: l’essentiel du PLFSS pour 2024
- USA – FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs
- Europe – EU medicines agencies reflect on lessons learned from COVID-19
- France – Respirateurs : nouveaux risques d’interférence entre des masques et des implants médicaux
- France – L’Assemblée nationale vote l’interdiction des cigarettes électroniques jetables
- Europe – Traitements anti-rhume : le comité du risque de l’Agence européenne des médicaments élargit les mesures de précaution
- France – Les intoxications avec les sachets de nicotine ou de tabac en hausse, surtout chez les jeunes, alerte l’Anses
- France – Durées de conservation dans le secteur social et médico-social : la CNIL publie un référentiel et une fiche pratique
- France – Espaces de télémédecine dans les gares: Aurélien Rousseau appelle à ne « pas mélanger soin et consommation »
- France – Antibiorésistance : une nouvelle stratégie interministérielle
- France – L’ordre des médecins exprime « sa profonde inquiétude » sur le projet d’installation d’espaces de télémédecine dans les gares SNCF
- France – Lionel Collet propose de nommer Jean Lessi à la direction générale de la HAS
- France – PLFSS 2024: recadrage de la durée des arrêts de travail et des prescriptions par téléconsultation
- Europe – JCVI advises on gonorrhea and mpox vaccinations
- USA – FDA Approves New Medication for Chronic Weight Management
- France – L’Académie de médecine redéfinit l’accès à ses séances en direct via YouTube
- France – Ordre des pharmaciens contre Livmed’s: le tribunal judiciaire de Paris sursoit à statuer
- UK – AI twice as accurate as a biopsy when grading severity of sarcomas
- UK – AI tools to speed up lung cancer diagnosis in NHS hospitals
- International – Interpol, global regulators seize $7 million worth of counterfeit drugs
- International – WHO releases 13 interventions to help address antimicrobial resistance
- France – En cas de rhume, évitez les médicaments vasoconstricteurs par voie orale !
- France – Vers des forfaits majorés pour la télésurveillance des diabétiques et insuffisants cardiaques
- France – Diabète : des taxis moléculaires pour lutter contre l’insulinorésistance
- France – Les cancers du larynx et de l’ovaire provoqués par l’amiante reconnus maladies professionnelles
- Spain – Spain Creates AI Regulator to Enforce the AI Act
- France – La France lance sa nouvelle stratégie en santé mondiale (2023-2027)
- France – Dépakine. « Un foutage de gueule immense » : le combat d’une mère, lanceuse d’alerte, pour faire indemniser ses enfants handicapés
- USA – Reimbursement, AI top list of priorities for new digital health lobbying group
- France – Papillomavirus : pourquoi la vaccination des garçons est-elle aussi essentielle ?
- India – India finds two more toxic syrups months after poisoning deaths
- International – WHO recommends second malaria vaccine for children
- International – Choléra : le nombre de cas rapportés à l’OMS a doublé entre 2021 et 2022
- International – Nobel Prize in Medicine awarded to pair of scientists behind mRNA COVID-19 vaccines
- International – Un deuxième vaccin contre le paludisme jugé « sûr et efficace » par l’OMS
- France – Budget PLFSS 2024 : des mesures au service de la santé et des solidarités collectives
- France – Bronchiolite : Succès de la campagne d’immunisation et priorisation vers les nourrissons
- International – World leaders commit to new targets to end TB
- Europe – Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies
- USA – US CDC recommends updated COVID-19 vaccines for autumn/winter season
- France – Vaccination contre les papillomavirus humains : Gabriel Attal, ministre de l’Education nationale et de la Jeunesse, et Aurélien Rousseau, ministre de la Santé et de la Prévention, lancent une campagne d’information nationale
- UK – New UK study suggests brain fog after COVID-19 is linked to blood clots
- France – Kétamine : l’usage récréatif a pris de l’ampleur en France, et avec lui l’apparition de complications graves
- France – Les cigarettes électroniques jetables « puffs » seront bientôt interdites, annonce Elisabeth Borne
- France – Levothyrox : l’ancienne formule distribuée en France jusqu’en 2025
- France – Évaluation du programme national de dépistage de la surdité permanente néonatale – Note de cadrage
- UK – NHS rolls out world-first programme to transform diabetes care for under 40s
- International – Le papillomavirus humain touche près d’un tiers des hommes dans le monde, selon une étude
- France – Actualisation des recommandations et obligations vaccinales des professionnels
- UK – NHS to roll out flu vaccines for children from September
- Europe – EMA’S Response to the COVID-19 Pandemic
- France – La prise de Dépakine chez le père pourrait présenter un risque pour l’enfant, prévient l’ANSM
- USA – GSK files lawsuit against Pfizer over RSV vaccine patent infringement
- International – Johnson & Johnson’s attempt to resolve talcum powder lawsuits fails a second time
- France – Aurélien Rousseau remplace François Braun au ministère de la santé et de la prévention
- France – Covid-19: clap de fin pour Sidep et TousAntiCovid
- France – Difficultés d’approvisionnement en corticoïdes (prednisone et prednisolone) : l’ANSM publie une recommandation pour les pharmaciens
- International – WHO says toxic syrup risk ‘ongoing’, more countries hit
- France – Respirateurs Philips défectueux : plus de 200 personnes portent plainte, dont trois pour homicides involontaires
- France – Tous les ans, 8 000 cancers induits par les infections à papillomavirus humain pourraient être évités
- Catégorie : Prestataires
