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  • France – Comment apparier des données cliniques avec les données du SNDS ?
  • USA – FDA issues final guidance on devices containing animal-derived materials
  • France – 32,3 jours : le délai d’attente pour une IRM urgente en 2018
  • France – ANSM – Nominations : Décision n° 2018-216 du 28/09/2018
  • Audio Tour App Detour Steers You Away from the Typical Tourist Traps
  • Mathematica 10 released on Raspberry Pi
  • I built an app that does triangulation of points on the earth
  • Terraform – Cross PaaS configuration management?
  • Scalable code without bloat: DCI, Use Cases, and You
  • Bonjour tout le monde !
• Catégorie : Médicaments
  • USA – Researchers Find 15% of Trials Could be Replicated Using Real World Data
  • UK – Increased discount leads NICE to reverse positon on Clovis cancer drug
  • UK – Elmiron bags draft NICE approval
  • Europe – Supplément 10.1 de la Ph.Eur. Les titulaires de CEP sont invités à mettre à jour leurs dossiers
  • UK – Importing medicines from the EEA after Brexit
  • UK – Licensing biosimilars, ATMPs and PMFs after Brexit
  • UK – How the MHRA will manage UK orphan medicinal products after Brexit
  • UK – Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, ‘grandfathering’ and managing lifecycle changes
  • Europe – The Eur. Ph. : pioneer of good health in Europe. “Memories of a European pharmacist” by Fernand Sauer
  • Europe – United Kingdom’s withdrawal from the European Union (‘Brexit’ Update)
  • USA – FDA Unveils New Tables for Submitting Bioanalytical Methods
  • Europe – Clinical Trial Regulation : Update
  • Europe – PRAC : Four-week limit for use of high-strength estradiol creams
  • France – Médicaments : le G5 appelle le gouvernement à « changer de doctrine »
  • Europe – 15 new reference standards and 16 replacement batches released in September 2019
  • China – Chinese biotech firm raises nearly $28M in Series B round
  • UK – Medicines that cannot be parallel exported from the UK
  • France – L’ANSM met en place un « fast-track » pour les produits innovants et dématérialise les procédures
  • UK – Variations to Marketing Authorisations (MAs) after Brexit
  • UK – ABPI details Brexit plans at PIPA conference
  • UK – NICE draft ‘no’ for Roche’s Tecentriq
  • Europe – When Can RWE Translate Into Credible Evidence? EMA Officials Discuss
  • Europe – Procedure for orphan medicinal product designation
  • Europe – How to ensure that novel analytic methods are fit for decision-making
  • USA – Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
  • USA – Generic Drugs Guidances & Reports
  • Europe – Delays in treatment of requests for revision and renewal of CEPs
  • Europe – Report from the CMDh meeting held on 17-19 September 2019
  • USA – FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels
  • France – Bordeaux : médicaments commercialisés sans autorisation, un pôle de recherche scientifique dans le collimateur
  • France – Nouvelle décision de police sanitaire à l’encontre du « Fonds Josefa » du Pr Fourtillan
  • France – Le Leem demande un moratoire sur les baisses de prix – PLFSS 2020
  • Switzerland – Swissmedic Takes Position on Fast-Track Reviews of Tissue-Agnostic Drugs
  • Europe – EMA Releases EudraVigilance List of Important Medical Event Terms
  • Europe – EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance and trusted deputy
  • UK – Sunset clause: request for public health exemption
  • UK – Applying for a Certificate of Pharmaceutical Product after Brexit
  • EMA -Change of name of liposomal medicines at high risk of medication errors
  • Europe – EMA EudraVigilance Registration Manual
  • UK – NICE delivers final ‘no’ for Novartis’ migraine treatment Aimovig
  • Europe – EMA advises companies on steps to take to avoid nitrosamines in human medicines
  • UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit
  • USA – New MAPP Offers Insight Into Patient-Oriented Labeling Consultations for Combination Products
  • USA – Genital herpes vaccine candidate heads for human studies
  • Switzerland – La Suisse valide l’utilisation du cannabis à des fins médicales
  • India – Indian regulators to put all drug approvals online
  • France – Le Professeur Fourtillan refuse de mettre un terme à ses travaux
  • France – Médicaments : les laboratoires bientôt sanctionnés en cas de pénurie
  • USA – FDA Compiles List of NDAs Transitioning to BLAs Next March
  • Australia – TGA Adopts Risk-Based Model for Fecal Microbiota Transplants
  • Europe – Un médicament à base de cannabis indiqué dans deux épilepsies infantiles autorisé en Europe et en France
  • USA – FDA Finalizes ALS Drug Development Guidance
  • USA – FDA Drug Competition Action Plan
  • UK – Takeda’s HAE drug Takhzyro backed by NICE
  • USA – FDA’s Comprehensive Response to HIV — Part I
  • Europe – Inclusion/exclusion criteria for the “Important Medical Events” list
  • UK – Businesses supplying medicines and medical devices: preparing for Brexit
  • France – Un essai clinique mené sans autorisation chez des patients atteints des maladies de Parkinson et d’Alzheimer interdit par l’ANSM
  • France – Mediator Ouverture d’un Procès Hors Norme
  • UK – NICE recommends Takhzyro
  • UK – Biological medicine quality to receive major boost
  • USA – FDA Explains Plans for New Pharmaceutical Quality Assessment System
  • USA – FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development
  • UK – NICE, PHE publish antimicrobial prescribing guidance on pneumonia
  • Europe – Data submission on authorised medicines (Article 57)
  • Europe – EMA to provide guidance on avoiding nitrosamines in human medicines
  • Europe – EMA to review ranitidine medicines following detection of NDMA
  • Europe – Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’
  • USA – When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates
  • Europe – Novartis Inhaler is First Device to be Certified Under MDR
  • Europe – EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante
  • Europe – Vaccination: European Commission and World Health Organization join forces to promote the benefits of vaccines
  • UK – NICE approves BioMarin’s Brineura after initial setback
  • Europe – EMA : Preparedness of medicines’ clinical trials in paediatrics
  • France – Une association de patients s’insurge contre l’embauche d’un ancien et récent haut responsable de la HAS par une société de conseils auprès de l’industrie pharmaceutique
  • Pakistan – After WHO Acceptance, Pakistan Drafts Pharmacovigilance Guidelines
  • USA – FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs
  • USA – FDA asks drug, biologics makers to use UCUM in electronic submissions
  • Europe – Spravato reduces depressive symptoms in 24 hours
  • USA – FDA approvals of new cancer drugs have doubled in this decade
  • USA – Cloud-based tracking system monitors drug adherence
  • USA – FDA Offers Advice on Extrapolating Efficacy of Seizure Drugs from Adults to Children
  • Europe – Ph. Eur. 10th Edition – Now available!
  • UK – NICE nod for Novartis’ Luxturna
  • UK – Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit
  • Europe – Paediatric investigation plans: questions and answers
  • UK – NICE publishes draft cerebral palsy quality standard
  • Europe – European Medicines Agency active-substance-master-file-number request form
  • China – China reduces penalties on unapproved drug imports
  • USA – Le ciseau génétique CRISPR pourrait permettre de créer des médicaments qui changent de forme
  • USA – FDA says widening probe on generic drug impurities
  • USA – FDA Finalizes Guidance on Placebos and Blinding for Cancer Trials
  • USA – FDA encourages inclusion of male patients in breast cancer clinical trials
  • France – Réforme des ATU : un décret fixe les conditions de remboursement
  • Europe – L’UE annonce une aide de 550 millions d’EUR pour sauver 16 millions de vies menacées par le sida, la tuberculose et le paludisme
  • Europe – EMA : policy on access to EudraVigilance data for medicinal products for human use
  • Europe – Brexit : pas de pénurie de médicaments en vue pour la France
  • Europe – Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
  • India – India to Add EU to List of Regions Covered by Clinical Trial Waiver
  • India – India Seeks Feedback on Mandatory use of QR Codes on API Packaging
  • Europe – EMA : procedural advice for users of the centralised procedure for generic/hybrid applications
  • Europe – EMA : procedural advice for users of the centralised procedure for similar biological medicinal products applications
  • Pharma’s development races are heating up
  • China – Novartis plans to submit 50 new drug applications in China by 2023
  • UK – NICE highlights need for more cannabis-based research
  • UK – NICE backs Keytruda plus chemo as first-line option for lung cancer
  • UK – Guidance on handling of Decentralised and Mutual Recognition Procedures in a no-deal Brexit
  • UK – Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no-deal Brexit
  • UK – Licensing of biological products: biosimilars, ATMPs and PMFs in a no-deal Brexit
  • UK – List of approved countries for authorised human medicines if there is a no-deal Brexit
  • USA – FDA: Novartis used faulty data to seek therapy approval
  • Canada – Canadian drug lobby pushes curbs on exports to US
  • UK – NICE recommends rivaroxaban funding to prevent strokes, heart attacks
  • Australia – Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?
  • USA – New FDA Guidances Target Women’s Health, Neonatal Care
  • Europe – Who’s calling the shots in European healthcare?
  • Europe – Quality data packages in early access approaches : workshop report published
  • Europe – Names of liposomal medicines to be changed to avoid medication errors
  • France – L’ANSM a constitué ses nouveaux comités scientifiques permanents – Point d’Information
  • Europe – EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020
  • USA – USP, British Pharmacopoeia Formalize Quality Standards Partnership
  • UK – NICE expands draft recommendation for Lokelma
  • Europe – EudraVigilance Release Notes v.1.20
  • USA – FDA updates draft guidance on rare pediatric disease priority review voucher program
  • Europe – EU Drug Shortage – The Impact of Brexit on Both the UK and EU-27 Member States
  • USA – FDA Finalizes Guidance on Delayed Graft Function in Kidney Transplantation
  • Canada – Guidance Document: Management of Drug Submissions and Applications – Revisions
  • Europe – First ‘histology-independent’ treatment for solid tumours with a specific gene mutation
  • Europe – European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
  • Europe – 25 July 2019 batch release
  • Russia – Compliance with Russia’s « most complex » track and trace requirements given a boost
  • International – Needle free: Erase wrinkles without injection
  • UK – NICE to form alliance to produce chronic asthma guideline
  • Europe – MA Electronic Submission : New Rules
  • Australia – TGA Updates Guidance on the Testing of Biological Medicines
  • Canada – Canada warns against US drug import proposals
  • USA – FDA Finalizes Combo Product Postmarket Safety Reporting Guidance
  • Europe – A Significant Number of Manufacturers have Failed to Connect to EU Medicines Verification System
  • Europe – CEP holders are invited to update their applications : 10th Edition of Ph. Eur.
  • USA – FDA Offers Technical Specifications for Submitting NGS Data on Antivirals
  • Europe – EMA takes note of the European Ombudsman’s decision on pre-submission activities
  • UK – MHRA launches consultation on how to best engage patients and the public
  • USA – FDA Discusses RWD, RWE With Industry, Academia
  • Europe – Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines en France
  • USA – FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer
  • USA – Updated Fundamentals of US Regulatory Affairs Book
  • UK – NICE U-turn for Kisqali in breast cancer
  • India – Indian drugmakers form partnerships as they enter the Chinese market
  • USA – FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection
  • Europe – Four new substances added to the Candidate List
  • Europe – Dosage Form Monographs for Public Consultation
  • USA – What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains
  • Europe – Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs
  • Europe – Le format eCTD est obligatoire pour tous les dossiers de CEP à partir du 1er janvier 2020
  • UK – The Human Medicines and the Medical Devices Regulations 2019
  • UK – AbbVie’s Skyrizi gets rapid ‘yes’ from NICE
  • USA – Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations
  • USA – FDA Revises 1999 Draft Guidance on Population Pharmacokinetics
  • UK – Implementing the Falsified Medicines Directive: Safety Features
  • Europe – Pharmeuropa 31.3 just released
  • Australia – Updates to variations to prescription medicines guidance and e-form
  • UK – Development of new antibiotics encouraged with new pharmaceutical payment system
  • France – Frédéric Collet élu à la présidence du Leem
  • France – HAS : Toutes nos publications par thèmes – Recommandations, médicaments, actes, dispositifs, …
  • USA – FDA Finalizes Revised REMS Modifications Guidance
  • UK – NICE Onpattro approval puts Alnylam back in hATTR running
  • Europe – EU invests €35 million to develop Artificial Intelligence solutions for cancer prevention and treatment
  • USA – FDA announces public health emergency prioritization of ANDAs for drug products for the emergency treatment of opioid overdose
  • Europe – Withdrawal of the United Kingdom and EU Rules in the Field of Good Laboratory Practice (GLP)
  • Europe – Annex 2: HaRP (Harmonisation of RMP Project) – methodology of harmonising RMPs
  • France – Androcur et ses génériques (Acétate de cyprotérone) et risque de méningiome : publication du rapport complet de l’étude de pharmaco-épidémiologie
  • France – ANSM : Paracétamol – Surdosage = Danger !
  • UK – AZ to appeal NICE rejection for lung cancer drug
  • Europe – Europe urged to adapt faster to gene therapy challenges
  • Europe – PRAC recommendations on signals
  • France – Parution du nouveau Guide Pharma
  • UK – NICE OK for life-extending Vizimpro in lung cancer
  • Canada – Risk Management Plans – Notice of clarification to drug manufacturers and sponsors
  • Europe – Medicine Shortages: EU Network takes steps to improve reporting and communication
  • India – India Proposes Making Marketers Responsible for Drug Product Quality
  • Europe – Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate
  • Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health
  • UK – NICE approves CDF funding for Sanofi’s Libtayo
  • Europe – Call for all sponsors to publish clinical trial results in EU database
  • France – HAS : « Choix méthodologiques pour l’évaluation de l’efficience à la HAS – Guide méthodologique
  • UK – Brexit Select Committee Hearing – Impact on the Pharmaceuticals Industry
  • China – Health leaders see fast growth in China pharma, biotech
  • USA – Drugmakers to electronically file promo materials for fast-track drugs
  • UK – Medicines and medical products supply: government updates no-deal Brexit plans
  • UK – Research supports better integration of patient voice in health technology assessments
  • UK – DHSC : Letter to Suppliers – Continuity of supply of medicines and medical products in 31st October no-deal EU exit scenario
  • USA – FDA Drafts Two New Guidances on Drug Labeling
  • USA – CBER Plans Draft Guidance on ‘Sameness’ of Gene Therapies Under Orphan Drug Regulations
  • UK – NICE pushes social prescribing for dementia
  • USA – FDA developing new guidance on opioid risk-benefit assessments
  • USA – FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics
  • Europe – One additional country to benefit from EU-US mutual recognition agreement for inspections
  • Europe – Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency
  • UK – NICE publishes draft guidance on adult leg ulcers
  • China – Chinese regulators hope to increase the number of generic drugs
  • UK – NICE hops on real world data trend to inform guidance
  • USA – FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines
  • UK – Innovative treatment for inflammatory eye condition recommended for use on the NHS
  • UK – Brexit Select Committee Hearing – Impact on the Pharmaceuticals Industry
  • UK – EU Exit preparedness
  • France – Androcur et ses génériques (Acétate de cyprotérone) et risque de méningiome : Résultats de l’enquête de pharmacovigilance
  • USA – Legislation would facilitate generic drug entry, raise tobacco-buying age
  • USA – « Research Investigational New Drug Applications – What You Need To Know » June 25, 2019 Issue
  • Europe – EC Aide-Memoire Aims to Help Drugmakers Comply With GMP Inspections Related to Falsified Medicines Delegated Regulation
  • USA – FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition
  • Australia – Australia Preps for Medicine Ingredient Name Changes
  • USA – Drugmakers Call for Changes to FDA Bioavailability Guidance
  • Europe – ECHA to scrutinise all REACH registrations by 2027
  • USA – FDA Finalizes Guidance on Advertising and Promotional Material Submissions
  • Canada – New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD)
  • USA – FDA program to respond to questions from stem cell therapy developers
  • USA – Iran, Argentina Join International Drug Regulators Group
  • USA – FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones
  • Europe – Management Board supports efforts to improve REACH authorisation and evaluation
  • UK – Drug Safety Update: monthly PDF newsletter
  • UK – NICE nod for Blincyto
  • Tout ce qu’il faut savoir sur les Biosimilaires – Interview du Pr Jean-Hugues Trouvin par Yves Tillet
  • USA – FDA : Statement on a new effort to improve transparency and predictability for generic drug applicants
  • France – La transplantation de microbiote fécal
  • UK – NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations
  • Europe – Update on the EDQM review of CEP applications for sartans and next steps (June 2019)
  • France – Androcur® : des patients mieux informés sur le risque de tumeur du cerveau
  • France – Sanofi et Google renforcent leur partenariat dans l’e-santé
  • Europe – Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure
  • Europe – EMA activities, other than the highest priority activities (category 1 activities), that will continue in 2019
  • USA – FDA approves new treatment for pediatric patients with type 2 diabetes
  • Europe – United Kingdom’s withdrawal from the European Union (‘Brexit’)
  • Europe – Brexit-related guidance for companies
  • Europe – Clinical Trial Regulation
  • UK – ABPI publishes new guidelines on pharma working with patients
  • USA – FDA, USP Clash Over Biologics Monographs
  • USA – Drugmakers Sue HHS for Trying to Add Prices to DTC Ads
  • UK – MHRA Offers Advice on use of Brand Names to Prescribe Drugs
  • France – Levothyrox et médicaments à base de lévothyroxine : Rapport final
  • France – Point de situation sur la disponibilité des corticoïdes en France – Point d’Information
  • Europe – General chapter 5.8 Pharmacopoeial harmonisation: new concept for the Ph. Eur. 10th Edition
  • Europe – Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs
  • Canada – Statement on the Investigational Use of Marketed Drugs in Clinical Trials
  • China – China to tighten rules on foreigners using genetic material
  • Europe – Brexit sans accord: la Commission européenne fait le point sur les préparatifs avant le Conseil européen (article 50) de juin
  • Europe – Two additional countries to benefit from EU-US mutual recognition agreement for inspections
  • Australia – Therapeutic goods advertising: Ensuring ‘natural’ claims are not misleading
  • USA – FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations
  • USA – CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis
  • Switzerland – Switzerland to Publish Pharmacopoeia for Free Online for the First Time
  • China – How trade war with China could hit US pharmaceutical makers
  • Europe – Member states contact points for translations review
  • USA – Current Good Manufacturing Practice for Medical Gases Guidance for Industry
  • Canada – Product Monograph Brand Safety Updates
  • USA – Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products
  • Europe – Recommendations on eligibility to PRIME scheme
  • Europe – Bientôt disponible : La Pharmacopée Européenne (Ph. Eur.) 10e Edition
  • USA – FDA to roll out patient access program to cancer drugs
  • UK – UK discourages use of paclitaxel devices for intermittent claudication
  • Europe – Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
  • USA – FDA Wins Federal Court Case Against Stem Cell Clinics
  • Europe – Consultation on draft guideline on quality requirements for medical devices in combination products
  • France – La prophylaxie pré-exposition (PrEP) au VIH par ténofovir disoproxil/emtricitabine (TRUVADA® et ses génériques)
  • Europe – Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications
  • Europe – List of centrally authorised products requiring a notification of a change for update of annexes
  • Europe – EudraVigilance Release Notes v.1.19
  • UK – Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines
  • Europe – EDQM inspections and trends of GMP deficiencies: Overview 2006 to 2018 (PA/PH/CEP(18) 56 April 2019)
  • UK – NICE issues guidance revision for depression
  • UK – NICE recommends MSD’s PREVYMIS®within licensed indication
  • USA – FDA Should Reassess Postmarket Trials for Cancer Drugs Approved via Accelerated Pathway, Researchers Say
  • India – CDSCO Creates Process for Companies That Lack Data Supporting Their FDCs
  • Europe – Etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day product-specific bioequivalence guidance
  • USA – FDA Approves First NDA Under Real-Time Oncology Review Pilot
  • France – Seule une refondation de la politique du médicament permettra de retrouver une industrie pharmaceutique compétitive
  • South Korea – EU regulators approve export of active ingredients from S. Korea
  • USA – What’s the Latest in Drug-Delivery Devices?
  • USA – FDA approves first PI3K inhibitor for breast cancer
  • Europe – EMA facilitates early engagement with medicine developers to combat antimicrobial resistance
  • UK – Final NICE guidance issued for Akcea’s Tegsedi
  • USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming
  • USA – FDA Chief of Staff Calls OTC Monograph Reform a Top Priority
  • France – ANSM : Cannabis à visée thérapeutique en France : Les experts poursuivent leurs travaux sur les modalités de mise à disposition
  • USA – FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations
  • USA – FDA Officials Explain When Litigation Can Impact Drug Safety Signals
  • UK – UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation
  • USA – FDA opening call center for access to unapproved cancer drugs
  • USA – Fragmin approved by FDA as first anticoagulant for children
  • UK – Exporting active substance manufactured in the UK in a no deal scenario
  • USA – NIH releases interactive data browser for precision medicine research
  • USA – FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India
  • UK – After discount row, NICE finally says yes to first line Revlimid
  • USA – Reassessing Benefit-Risk: FDA Preps for New Guidance
  • Canada – Performance Standards for the Fees in Respect of Drugs and Medical Devices Order
  • USA – FDA Unveils 34 New and Revised Product-Specific Draft Guidances
  • South Korea – European Commission Confirms Quality of South Korean Active Substances
  • UK – NICE recommends Sprinraza for 5q spinal muscular atrophy
  • Canada – Santé Canada propose d’accélérer l’approbation de certains médicaments pour cas rares
  • USA – MAPP Describes the Work of CDER’s Biopharmaceutics Council
  • UK – Potential first ever targeted therapy designed for ‘untreatable’ childhood brain cancer
  • USA – Interchangeable Biosimilars: FDA Finalizes Guidance
  • USA – When to Submit an ANDA vs. a 505(b)(2)? FDA Explains
  • USA – FDA Finalizes Maximal Usage Trials Guidance for Topical OTC Drugs
  • USA – Evaluating Reproductive Toxicity in Oncology Drugs: FDA Finalizes Guidance
  • Europe – Brexit « having impact on EU drug development”
  • USA – Studying Drugs in Pregnant and Nursing Women: FDA Issues Draft Guidances
  • USA – RWE Submissions: FDA Drafts Guidance
  • USA – List Prices in Drug Ads on TV Coming as CMS Finalizes Rule
  • USA – FDA to Study DTC Ads for Drugs Approved Under Accelerated Process
  • France – Le GEMME se félicite de l’adoption d’une mesure en faveur de l’industrie européenne de fabrication des médicaments génériques et biosimilaires
  • France – Signature de l’avenant à l’Accord-cadre « nouvelle procédure de négociations des prix au CEPS »
  • Europe – EMA annual report 2018 published
  • Europe – EMA : Working together for safe medicines in the EU
  • USA – FDA Drafts Guidance for Developing Drugs to Treat ADHD
  • Canada – Release of Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs)
  • Europe – Sartans Article 31 referral – CHMP assessment report
  • UK – NICE recommends Roche’s Tecentriq for metastatic NSCLC
  • Europe – Widespread Concern Over Europe’s Uncertain Regulatory Future Highlights Region’s Importance
  • USA – Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements December 2018
  • USA – Guidance, Compliance & Regulatory Information (Biologics)
  • USA – Framework for the Regulation of Regenerative Medicine Products
  • USA – MedWatch: The FDA Safety Information and Adverse Event Reporting Program
  • France – ANSM : Venclyxto (vénétoclax) : signal de sécurité issu de l’essai clinique évaluant le vénétoclax dans le traitement du myélome multiple – Point d’Information
  • USA – Drugmakers, EMA Comment on FDA Guidance on Assessing Food Effects on Drugs
  • USA – FDA accused of failing to act on Parkinson’s drug dangers
  • USA – FDA Adds Boxed Warnings to Insomnia Medicines Following Injuries, Deaths
  • China – CDE Shares Chinese Medicine Clinical Research Guidelines for Consultation
  • India – India Posts Guide to Revised Rules on New Drugs and Clinical Trials
  • Europe – EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo
  • USA – FDA Drafts Guidance on Adjusting for Covariates in Randomized Trials
  • France – Antiépileptiques au cours de la grossesse : Etat actuel des connaissances sur les risques de malformations et de troubles neuro-développementaux
  • USA – FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products
  • USA – FDA : New steps to strengthen the process of initiating voluntary recalls
  • Europe – Draft ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines – Overview of comments received
  • USA – FDA issues final rule on OTC hand sanitizers
  • USA – Bispecific Antibodies: FDA Drafts Guidance for Developers
  • France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves – Point d’Information
  • UK – NICE final guidance published for Cimzia
  • Europe – Pharmaceuticals: EU refines intellectual property rules
  • Europe – Registered substances mapped for regulatory action
  • Canada – Health Canada Opens Generic Drug Guidances for Consultation
  • UK – Akcea steals march on Alnylam with NICE approval
  • Europe – Update of EU recommendations for 2019/2020 seasonal flu vaccine composition
  • Europe – European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit
  • Europe – EMA Enters Into Information-Sharing Agreement With EU Quality Body
  • Switzerland – Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans
  • USA – FDA Expands RWE Demonstration Project
  • France – ANSM : Répertoire des médicaments génériques -Avril 2019
  • France – Indemnisation record pour les malades du Mediator
  • Europe – Préparation à un Brexit sans accord: la Commission européenne dresse le bilan des préparatifs et fournit des orientations pratiques pour garantir une approche coordonnée au niveau de l’UE
  • UK – Novartis’ Kisqali hit with NICE rejection
  • UK – UK requests another Brexit deadline extension, furthering market uncertainties
  • USA – FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
  • UK – MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates
  • France – LEVOTHYROX : la nouvelle étude annoncée par la presse n’est qu’un article d’opinion
  • Asia – New pharmaceutical company launches in Asia
  • India – Generic breast cancer drug coming to India
  • UK – NICE appraisal for BMS kidney cancer immunotherapy combination
  • USA – When a REMS is Necessary: FDA Finalizes Guidance
  • USA – FDA Identifies ARBs Without Impurities
  • USA – Patient Groups, Industry Seek Changes to Rare Disease Drug Guidance
  • France – Levothyrox : les deux formules du médicament ne seraient pas substituables, selon une étude
  • UK – MHRA Offers Additional No-Deal Brexit Guidance
  • Canada – Release of ICH E6(R2): Good Clinical Practice – Notice
  • Europe – Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines
  • Australia – TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals
  • Europe – First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)
  • USA – Gottlieb signs off with flair – and pledge of further drug price commentary
  • USA – FDA Begins Plotting Pathway for Cannabis Product Approvals
  • France – Lipidots : des cargos moléculaires pour la délivrance de médicaments
  • USA – FDA releases new digital health rules for pharma companies
  • USA – Revocation of the Test for Mycoplasma
  • UK – NICE nod for Lilly’s breast cancer drug Verzenio via CDF
  • Europe – EU recommendations for 2019/2020 seasonal flu vaccine composition
  • Europe – Regulatory information – 1.7% increase of fees from 1 April 2019
  • Australia – Guidance for TGO 101
  • UK – BREXIT : où en est-on ?
  • Europe – BREXIT : Fiches d’information et FAQ
  • Europe – New gene therapy to treat rare inherited blood condition
  • Europe – Symposium EDQM-USP : les différentes utilisations des étalons de référence de pharmacopée
  • Europe – New EudraVigilance system improves reporting of side effects and detection of safety signals
  • Europe – Scientists Gene-Edited Tequila Bacteria to Make Cannabinoids
  • UK – NICE green light for Imfinzi in groundbreaking early lung cancer treatment
  • Europe – 20 years of sampling & testing programme for medicines authorised for the EU
  • USA – Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling Guidance for Industry
  • Europe – European authorities working to avoid shortages of medicines due to Brexit – Questions and answers
  • Europe – Brexit-related guidance for companies
  • USA – CBER Finalizes Guidance on Use of Standards in Regulatory Submissions
  • India – Indian regulators waive clinical trials for drugs approved elsewhere
  • UK – NICE recommendation for Steglatro in type II diabetes
  • Europe – HSCT Remains Standard in Childhood ALL, Despite CAR T-Cells
  • Europe – European Panel Offers Advice on Complex Drug Trials
  • USA – NCCN: Updated NSCLC Guidelines Hone in on PD-L1 Testing
  • USA – FDA Promises Flexibility for Stem Cell Trials
  • USA – Natural History Studies for Rare Diseases: FDA Drafts Guidance
  • UK – NICE nod for Takeda’s Adcetris in advanced stage CTCL
  • Europe – EMA Management Board: highlights of March 2019 meeting
  • USA – FDA’s OCP Works to Modernize Review Functions
  • USA – Applying human factors to nicotine replacement therapy drug products
  • UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices
  • USA – FDA Finalizes Two Guidances on HIV Drug Development
  • Australia – Australian manufacturing licences and overseas GMP certification
  • UK – A Right Royal Deadlock: Can « Crown » use unlock patented drug?
  • USA – FDA suggests letting more patients with viral infections into cancer clinical trials
  • USA – FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders
  • Canada – Health Canada Begins Release of Clinical Data on Drugs and Devices
  • USA – Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance
  • USA – Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products Guidance for Industry
  • Europe – ICH M10 on bioanalytical method validation
  • Australia – Updated GMP licence application e-forms
  • UK – Completed Paediatric Studies – submission, processing and assessment in the event of a no deal scenario
  • USA – FDA approves a new generic valsartan
  • USA – FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility
  • UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal
  • China – China may launch trials on new gene-editing technology within 2 years
  • France – Nouvelle mesure d’accès à l’innovation : ATU de cohorte d’extension d’indication pour l’utilisation de Lynparza dans certains cancers gynécologiques
  • UK – NICE u-turn backs use of Darzalex combo for myeloma relapse
  • UK – UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines
  • Europe – EMA now operating from Amsterdam
  • UK – NICE nod for Almirall’s Ilumetri, UCB’s Cimzia
  • Europe – Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials
  • UK – NICE updates high blood pressure guidelines
  • China – China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal
  • UK – Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal
  • UK – Delays to cancer testing and treatment ‘inevitable’ after Brexit
  • USA – FDA approves new nasal spray medication for treatment-resistant depression
  • UK – NICE evidence request for Blincyto for acute lymphoblastic leukaemia
  • USA – Gottlieb to Resign as FDA Commissioner
  • Europe – Adjusted fees for applications to EMA from 1 April 2019 – Regulatory information
  • USA – New Impurity Found in Blood Pressure Drug Prompts Expanded FDA Recall
  • France – Gardasil 9: Les françaises plus résistantes que les américaines?
  • France – Le déremboursement entraîne une hausse immédiate des ventes des médicaments non remboursables
  • USA – FDA Finalizes Guidance on 503B Bulks List
  • Europe – EMA Closes London Office, Preps for New Time Zone
  • Europe – Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products
  • Europe – New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
  • Europe – CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease
  • Europe – First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban
  • Europe – First treatment for rare disease characterised by high levels of triglycerides in blood
  • Europe – New add-on treatment for patients with severe asthma
  • Europe – Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation – Overview of comments received
  • UK – How to make submissions to the MHRA if the UK leaves the EU with no deal
  • Europe – First guidance for managing Drug/Device combination
  • Europe – Elemental impurities reference standards: leaflets now include expanded uncertainty
  • Europe – The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8.
  • USA – Continuous Manufacturing: FDA Drafts Quality Guidance
  • Europe – Procedural update on submission of Type I variations to EMA in March, April and May 2019
  • India – India Advances Plan to Create Mobile Drug Testing Laboratories
  • UK – Roche Wins Approval for Perjeta in Breast Cancer Subgroup
  • France – Maladies rares : l’Inserm coordonne un programme européen d’ampleur inégalée
  • USA – Generic Drugs: FDA Releases 74 Product-Specific Guidances
  • USA – FDA Defends its Efforts to Ensure Generic Drug Quality
  • France – « Pharma Papers ». Produire des médicaments « équitables », efficaces et au juste prix : les Pays-Bas l’ont fait
  • France – OPIOÏDES : augmentation des décès, des intoxications et du mésusage selon l’ANSM
  • Europe – Les eaux à usage pharmaceutique : principes de production et critères de la Ph. Eur.
  • USA – FDA Offers Guidance on Nicotine Replacement Therapies
  • Europe – EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials
  • UK – Brineura hit with NICE rejection
  • Germany – BfArM’s recommendations regarding clinical trials with medicinal products where sponsor or legal representative are established in the United Kingdom
  • Europe – EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database
  • UK – UK Offers No-Deal Brexit Guidance for Biologics Manufacturers
  • Europe – Le droit de la concurrence comme vecteur de l’accès à des médicaments abordables et innovants en Europe
  • UK – ‘Inflexible’ NICE blocking access to rare disease drugs
  • France – Le Cabinet WHITE-TILLET recrute un consultant, docteur en pharmacie ou ingénieur
  • UK – Report finds NICE’s routine appraisals need reform
  • India – Indian regulators tweak drug trial rules
  • France – Clinical trials on medicinal products submitted to the ANSM as part of the FastTrack procedure
  • USA – Regenerative Medicines: FDA Finalizes Guidance on Expedited Programs
  • UK – Widening the availability of naloxone
  • Europe – EMA suspends fenspiride medicines due to heart rhythm risks
  • USA – Competitive Generic Therapy Designations: FDA Explains Process in New Draft Guidance
  • China – China plans to reduce VAT for rare disease therapies
  • UK – Advertise your medicines
  • Europe – Role of big data for evaluation and supervision of medicines in the EU
  • UK – Alunbrig recommended by NICE for non-small-cell lung cancer
  • UK – NICE changes its mind on Perjeta
  • UK – Novartis first to benefit from NICE advice on ‘patient preference’
  • USA – Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds
  • Europe – Initiative citoyenne européenne: la Commission enregistre l’initiative «Let’s demand smarter vaping regulation!»
  • UK – New NICE guidelines on antibiotic prescribing for pneumonia
  • UK – New ‘Trojan horse’ cancer treatment shows early promise
  • Europe – EMA : New online platform for parallel distribution
  • UK – ABPI warns of greater exposure to fake meds under no-deal Brexit
  • France – Sérialisation : une sécurité des médicaments renforcée
  • Australia – Australia Looks to Improve Generic Drug Authorization Process
  • Europe – Guideline on clinical investigation of medicinal products for the treatment of gout
  • Europe – Implementing the Falsified Medicines Directive: Safety Features
  • Europe – Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3
  • USA – FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder
  • USA – FDA Finalizes Buprenorphine Drug Development Guidance
  • USA – Regulatory Intelligence, Risk Management and Drug Promotion
  • Europe – L’Italie saisit la justice européenne sur la relocalisation de l’Agence du médicament à Amsterdam
  • UK – Mapping of oesophageal cancer gene mutations leads to new drug targets
  • USA – USP’s Generics Access Plan to Aid FDA Efforts
  • USA – FDA Announces Plans for Advancing Cell and Gene Therapies
  • Europe – Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
  • Europe – First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
  • UK – Kymriah gets NICE approval for DLBCL
  • Europe – Guide technique pour l’élaboration des monographies de vaccins et sérums pour usage humain – Mise à jour
  • Europe – European Commission Consults on Orphan Drug Applications
  • France – REVUE PRESCRIRE : LA LISTE NOIRE DES 68 MÉDICAMENTS DANGEREUX
  • USA – Marketing Status Notifications: FDA Drafts Guidance
  • Europe – UK and Russia sign MoU on Regulatory Cooperation on Medicines
  • USA – FDA Pushes Back eCTD Deadline for Type III DMFs Again
  • Europe – European Commission Focuses New Report on Pharma Competition Enforcement
  • Europe – European Commission Updates Q&A on Safety Features for Medicinal Products
  • Europe – Novartis urges government to ‘minimise disruption’ in no-deal Brexit
  • USA – FDA Takes Steps to Address Root Causes of Sartan Safety Issues
  • UK – UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit
  • USA – FDA Issues Draft Guidance on Tentatively Approved ANDAs
  • Europe – Ph.Eur. Supplement 9.8 available now
  • USA – Assessing the Effectiveness of REMS: FDA Drafts Two New Guidances
  • Europe – Shire Raises ‘Substantial Concerns’ About ICH Guidelines in Feedback to EMA
  • USA – Immunogenicity Testing: FDA Finalizes Guidance on Assay Development and Validation
  • UK – How to make regulatory medicines submissions to the MHRA if the UK leaves the EU with no deal
  • Australia – TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP
  • Europe – EMA relocation updates
  • UK – NICE backs digital CBT for mildly depressed children and young people
  • USA – FDA Offers ICH S11 Guidance for Comment as Shutdown Threatens Further Guidance
  • USA – FDA Finalizes Accelerated Approval Labeling Guidance
  • Europe – Supplément Ph. Eur. 9.8: les titulaires de CEP sont invités à mettre à jour leurs dossiers
  • Europe – EMA issues draft guidelines on antibiotic studies
  • UK – Brexit No-deal: MHRA Looks to Ease Grandfathering of Centrally Authorized Products
  • UK – Trivalent gets UK green light for flu in over 65s
  • Europe – EU Advances SPC Waiver Proposal
  • France – Génériques. L’association Gemme présente des résultats 2018 jugés moroses
  • France – Pénurie de vaccins et de médicaments : Les inquiétudes de France Assos Santé confirmées par une enquête exclusive
  • UK – NICE endorsement means more donor livers could be used for transplantation
  • USA – FDA Drafts Guidance on Tentatively Approved ANDAs
  • USA – FDA Revises Draft Guidance on Rare Diseases
  • UK – NICE approval for Verzenios in metastatic breast cancer
  • UK – Venetoclax gets NICE approval for chronic lymphocytic leukaemia
  • UK – NICE OK for Bravtovi skin cancer drug
  • Europe – Europe closer to biosimilar rule change, despite fierce resistance from pharma
  • USA – FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices
  • USA – FDA to beef up cell and gene therapy staff
  • France – L’année 2019, une année cruciale pour la loi « anti-cadeaux » !
  • Europe – Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing
  • Europe – Regulatory Science to 2025
  • Australia – TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data
  • Europe – Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods
  • Europe – Evaluation of anticancer medicinal products in man : Concept paper on the revision of the guideline
  • Europe – Revised guideline aims to strengthen global approach to development of new antibacterial medicines
  • USA – Lilly CEO on future cancer deals, gene therapy and CAR T-cells
  • Europe – Solution concentrée d’infliximab : première monographie d’anticorps monoclonal dans la Ph. Eur.
  • Europe – Produits biothérapeutiques vivants (PBV) : exigences de qualité sans précédent fixées par la Commission
  • France – Cancer du système lymphatique : deux nouveaux traitements s’affichent à plus de 300 000 euros
  • UK – Good pharmacovigilance practice
  • UK – NICE says Novartis’ migraine drug Aimovig too costly for NHS
  • Canada – Bipartisan Bill would allow Drug Imports from Canada
  • USA – Gottlieb describes Innovation Office, Biosimilars Policies at JPM
  • Europe – Guidance for marketing authorisation transfer – National requirements
  • UK – Stivarga final NICE recommendation for hepatocellular carcinoma
  • Europe – Principe des 3R : avancées de la Commission européenne de Pharmacopée ces dix dernières années
  • USA – CDER Outlines Drug Safety Priorities
  • Europe – Renforcement de la coopération entre les pharmacopées européenne et indienne
  • UK – Implementing the Falsified Medicines Directive: Safety Features
  • Europe – EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals
  • Europe – ‘Certification of Suitability to the monographs of the Eur Ph’ : Revised EDQM Guidelines
  • Europe – EDQM revised guideline on Content of the dossier for chemical purity and microbiological quality
  • USA – Drug Sponsors Urge FDA to Think Bigger About Master Protocols
  • UK – NICE approves Xeljanz for Ulcerative Colitis
  • UK – Drug pricing is pharma’s top concern in 2019
  • UK – AstraZeneca wins NICE backing for asthma injection
  • Europe – Human medicines: highlights of 2018
  • UK – MHRA responds to consultation on Brexit no-deal proposals
  • USA – FDA updates endpoint guidance for cancer trials
  • USA – FDA helps to lead fight against antimicrobial resistance
  • France – Novartis to buy France’s CellforCure to boost cell, gene therapy
  • USA – Aorta Tears With Certain Antibiotic Use, FDA Warns
  • UK – NICE recommends Lenvima for advanced liver cancer
  • UK – NICE publishes updated guidance with expanded recommendation for Oncotype DX
  • Europe – Update on the review of CEP applications for sartans
  • USA – FDA Revises Guidance on Oncology Endpoints
  • UK – EU & NICE authorise MSD’s Keytruda for stage III melanoma
  • USA – Warren Seeks to Create Government-Run Generic Drug Manufacturer
  • Europe – Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)
  • USA – FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices
  • Europe – Omega-3 Meds Not Effective After MI, EMA Panel Concludes
  • USA – Drugmakers Call for Clarification of FDA’s Postapproval Change Guidance
  • Europe – Guideline on Active Substance Master File Procedure
  • UK – NICE appraisal fees to be introduced despite opposition
  • Europe – Draft guideline on quality and equivalence of topical products
  • Europe – Procédure de « Certification de Conformité aux monographies de la Pharmacopée européenne » – révision de certaines lignes directrices
  • USA – FDA Withdraws Proposed Rule on Generic Label Changes
  • Europe – Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
  • UK – NICE rejects NHS funding for Tegsedi, Onpattro
  • USA – Gottlieb: New FDA policies could pave way for interchangeable insulin
  • USA – Biomarker Qualification: FDA Drafts Guidance
  • USA – Definition of the Term “Biological Product”
  • UK – NICE says no to rival Alnylam and Akcea amyliodsis drugs – but deal could be done
  • Europe – Nouvelle ligne directrice de l’EDQM « Comment lire un CEP »
  • New Zealand – New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections
  • China – China publishes 38 punishments for IP fraud, theft
  • USA – FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics
  • Europe – Major 3Rs achievement for Official Control Authority Batch Release of human vaccines
  • USA – New efforts to assure the quality of compounded drugs
  • UK – Pharma calls for more detail on plan for post Brexit meds access
  • UK – NICE turns down Opdivo/Yervoy combo for kidney cancer
  • Canada – Premarket Device Cybersecurity: Health Canada Issues Draft Guidance
  • USA – FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says
  • UK – NICE OKs NHS funding for Gilead’s CAR T-cell therapy
  • Europe – Détection d’impureté dans le valsartan : les mesures prises par l’EDQM ces dernières semaines
  • Europe – EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals
  • Europe – Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal
  • UK – NICE backs Cimzia for psoriasis, but rejects Ilumetri
  • USA – FDA Issues Draft Guidance on NASH Drug Development
  • USA – Biosimilars Forum Calls for FDA Guidance to Address Misinformation
  • USA – Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances
  • Europe – EDQM laboratory: new NMR accreditation strengthens characterisation capacity for reference standards
  • Europe – Update on the review of CEP applications for sartans
  • Europe – Ph. Eur. Section 3. Materials and containers: clarification of legal status
  • USA – FDA Finalizes Guidance on Post-CRL Meetings With ANDA Applicants
  • France – Le CNOP dévoile trois rapports sur la prévention, les nouvelles technologies et la pharmacie clinique
  • France – Le médicament Levothyrox au cœur d’un procès hors norme
  • Europe – Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products
  • UK – Immunotherapy extends the life of head and neck cancer patients
  • USA – GAO Raises Questions on FDA’s Orphan Drug Designation Process
  • France – Nouveau rappel de médicaments à base de valsartan
  • Europe – Revised guideline to assess risk of human medicines for the environment
  • Europe – Data from patient registries to replace clinical trials in previously untreated haemophilia patients
  • UK – NICE u-turn on Opdivo for skin cancer recurrence
  • International – How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?
  • France – Les Prescriptions médicamenteuses hors AMM en France : une clarification indispensable
  • UK – Bayer’s Stivarga wins NICE backing for advanced liver cancer
  • USA – New Product-Specific Guidances Focus on Drugs Without Generic Competition
  • Europe – European Commission Revises Q&A on Safety Features for Medicinal Products
  • Europe – Reflection paper on the qualification of non-genotoxic impurities
  • France – Médicaments : rapport sur le progrès thérapeutique, édition 2018
  • France – Baromètre Ipsos/Leem 2018 du médicament
  • USA – Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages
  • UK – NICE lung cancer backing for Keytruda is biggest expansion yet
  • International – ‘Reprogrammed’ stem cells implanted into patient with Parkinson’s disease
  • Europe – Révision du Guideline relatif à la Révision ou au Renouvellement de CEP : version corrigée disponible
  • USA – FDA Works to Reduce Dog Testing in Drug Development
  • Europe – Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
  • Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668)
  • Europe – Reflection paper on regulatory requirements for the 5 development of medicinal products for chronic non6 infectious liver diseases (PBC, PSC, NASH).
  • Europe – Update on the review of CEP applications for sartans
  • Europe – Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract
  • France – ATU – Autorisations temporaires d’utilisation
  • Europe – Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics
  • Europe – CHMP recommends first oral-only treatment for sleeping sickness
  • France – ALCOOL : LE BACLOFÈNE OBTIENT SON AMM
  • Europe – Guideline on the quality of water for pharmaceutical use
  • France – Les « Pharma Papers » : tout ce que les labos pharmaceutiques voudraient vous cacher
  • France – Homéopathie : 74 % des Français veulent le maintien du remboursement
  • France – Hépatite C. Le laboratoire Gilead baisse le prix de ses coûteux traitements de 20 %
  • UK – NICE issues final draft guidelines for Novartis’ Kymriah
  • Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
  • France – Médicaments : une évaluation rigoureuse et scientifique par la HAS
  • USA – FDA touts record-breaking number of October generic approvals
  • UK – Final NICE green light for Pfizer’s Mylotarg
  • France – Renouvellement de la commission de la transparence de la HAS
  • France – Faut-il lyncher les médecins payés par les laboratoires pharmaceutiques ?
  • USA – FDA Drafts Guidance on Using Metastasis-Free Survival Endpoints in Prostate Cancer Posted 13 November 2018 | By Ana Mulero
  • Europe – EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision
  • Japan – Stem cell-based Parkinson’s therapy tested in Japan
  • USA – New drug options, risk factors added to U.S. heart guidelines
  • France – MÉDICAMENTS en LIGNE : Les conditions d’une automédication en toute sécurité
  • France – L’ANSM met en place un dispositif accéléré d’autorisation d’essais cliniques (Fast Track)
  • Europe – WORKING WITH STAKEHOLDERS TO IMPROVE AVAILABILITY OF MEDICINES IN THE EU
  • USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program
  • Europe – EMA Issues Guideline on GVP Considerations for Pediatric Populations
  • UK – NICE says no to expanding use of AZ’ Lynparza
  • UK – Industry Finds Fault With UK Vision for Drug Regulation After Brexit
  • UK – NICE nod for Jazz’ AML chemo
  • USA – FDA Issues Guidance on Dried Plasma Products for Blood Transfusions
  • Europe – Organs, Tissues and Cells – Technical Guides
  • USA – FDA Finalizes Guidance on Developing Fixed Combination Hypertension Drugs
  • USA – Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance
  • China – China Creates Guidance to Fast Track Important Drugs Approved Overseas
  • France – L’ancienne formule du Levothyrox sera bien disponible en 2019
  • Europe – EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India
  • USA – Hepatitis B Virus Drug Development: FDA Offers Draft Guidance
  • USA – Vanda Lands OPDP Warning Letter Over Risk Info on Website
  • UK – Supply unlicensed medicinal products (specials)
  • UK – NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer
  • Europe – EMA’s Rasi on Genome Editing: Time to Move Forward
  • USA – U.S. FDA Approves TherapeuticsMD’s Menopause Drug
  • UK – AbbVie’s Venclyxto hit with NICE rejection
  • France – Loi n° 2018-892 du 17 octobre 2018 relative à la désignation aléatoire des comités de protection des personnes
  • UK – AbbVie’s Venclyxto hit with NICE rejection
  • UK – NICE turns down hyperkalaemia therapies
  • France – Un médicament fait ses preuves contre le cancer du sein hormonodépendant
  • USA – FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline
  • France – Médicaments : d’inquiétantes ruptures de stock
  • USA – FDA warns 465 websites selling unapproved opioids, drugs for cancer, HIV
  • USA – FDA Finalizes Testicular Toxicity Guidance
  • USA – FDA Approves Anti-Flu Pill – First New Treatment in Nearly 20 Years
  • USA – Verification Systems: FDA Drafts Guidance on What to Include
  • France – Alcoolisme : le baclofène autorisé sous certaines conditions
  • USA – FDA Explains How to Craft a Data Management Plan
  • China – China Charges Vaccine Manufacturer $1.3B for Quality Failings
  • Immunotherapy improves survival in patients with metastatic breast cancer
  • USA – FDA committee to discuss CV trials for diabetes drugs
  • International – Immuno-Oncology: What’s Next for Pharma?
  • France – Plainte d’Anticor contre des experts du cholestérol
  • UK – NICE rejects Lilly’s breast cancer drug Verzenios
  • USA – FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH
  • Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018
  • USA – La FDA (Food and Drug Administration) approuve la première pilule numérique
  • France – Plateforme de signalement des effets indésirables : un premier bilan
  • UK – NHS set to save £150 million by switching to new versions of most costly drug
  • France – Un référentiel pour justifier le « non substituable » ? Médecins et pharmaciens craignent une usine à gaz
  • France – L’agence du médicament lance un dispositif accéléré d’autorisation d’essais cliniques
  • USA – Oncologists’ Off-Label Prescribing Pits Access Against Reimbursement
  • Europe – EMA Scales Back Medium-Priority Activities as Brexit Bites
  • USA – FDA issues draft guidance to enhance efficiency in drug development
  • France – La commission de la transparence précise et adapte ses principes d’évaluation des médicaments
  • USA – Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence
  • UK – UK Expands Access to Medical Cannabis
  • USA – FDA Sets Record for Number of Generic Drug Approvals Again
  • China – China approves 17 anti-cancer drugs for medical insurance coverage
  • Europe – The European Medicines Agency (EMA) has launched a new version of its corporate website
  • Europe – EMA/EDQM Find Major Deviations at China Manufacturer Embroiled in Valsartan Contamination
  • UK – XLH patients to get routine access to first new therapy in 30 years
  • USA – FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products
  • Europe – Brexit-related guidance for companies
  • USA – Complex Generic Drugs: FDA Offers Two Draft Guidances
  • USA – FDA OKs Inotersen (Tegsedi) for Hereditary ATTR With Polyneuropathy
  • Europe – Falsified Medicines Directive: Implications for parallel importers and of Brexit
  • UK – FMD regulations won’t apply after ‘no-deal’ Brexit, says MHRA
  • USA – The First FDA-approved Digital Pill – What It Means for Pharma
  • USA – Study: Prenatal gene editing treats congenital disease in mice
  • UK – Gilead strikes deal with NHS England on Yescarta access
  • USA – New Flu Drug Cuts Time to Recovery
  • South Korea – S. Korean officials extend seasonal flu vaccine to very young children
  • Japan – Japanese study underscores efficacy of HCV drug elbasvir/grazoprevir
  • USA – Atopic Dermatitis: FDA Finalizes Guidance on Timing of Pediatric Studies
  • USA – Citizen Petitions: FDA Revises Guidance to Block Drugmakers From Abusing the System
  • Europe – EU nod for Lilly’s new breast cancer drug
  • Europe – Drug reaction reporting scheme now more accessible to healthcare professionals
  • Europe – UK launch for Alliance’s pregnancy anti-nausea and vomiting drug
  • USA – FDA Warns of Dosing Errors With Compounded Injectables
  • USA – Drugmakers Call for Changes, Additions to FDA’s Purple Book
  • USA – Clinical Trials: FDA Releases Two Draft Guidances
  • USA – US green light for Pfizer’s lung cancer drug
  • USA – Special 510(k)s: FDA Seeks Input to Expand Eligibility
  • Europe – Draft NICE decision rejects Respreeza for incurable, genetic disorder
  • Europe – High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin
  • Europe – CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys
  • USA – Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance
  • China – Third Form 483 Surfaces for China Company at Center of Valsartan Contamination
  • USA – End of the eCTD? FDA Pushes for New KASA System to Improve Assessments
  • USA – J&J files ‘breakthrough’ bladder cancer drug in US
  • USA – CDRH Finalizes Guidance to Reduce Heparin Product Overdose Errors
  • Europe – NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma
  • France – AFAR : soirée BREXIT
  • USA – Data Integrity a Top Concern for Manufacturers, FDA Says
  • China – Takeda gets China’s approval for $62 billion Shire purchase
  • Europe – NICE nod for Novartis’ targeted skin cancer combo
  • UK – ‘Streamlined’ medicines regulation promised in ‘No Deal’ Brexit scenario
  • USA – US approves AZ’ hairy cell leukaemia drug
  • Europe – Regulators Detail Challenges in Defining Orphan Conditions in EU
  • USA – ANDA Technical Specifications: FDA Guidance
  • China – Chinese API Manufacturer Refuses EU Officials’ Inspection
  • USA – FDA awards another non-opioid pain drug breakthrough status
  • France – Philippe Tcheng élu Président du Leem
  • Europe – Good clinical practice for clinical trials
  • Europe – Dismay as NICE rejects Roche’s MS drug Ocrevus
  • Europe – EC green-lights MSD’s Keytruda combo for lung cancer
  • Europe – Les mauvais brevets limitent l’accès aux médicaments en Europe
  • Europe – Pre-authorisation guidance
  • USA – Industry, Pharmacists Call for Changes to FDA Labeling Guidance
  • USA – AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status
  • USA – FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence
  • UK – The Family-run Fake Pill Factory: trio busted following drugs raid
  • France – Zelboraf/Cotellic : Rappel du risque d’atteintes opthalmiques et de leur prise en charge
  • Europe – Revised Guideline on requirements for revision/renewal of CEPs
  • USA – Complex Innovative Trial Designs Pilot Program
  • UK – DHSC publishes Brexit guidance for pharmaceutical industry and suppliers of medical devices
  • USA – FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation
  • Europe – NICE U-turn on Crystiva for rare bone disease
  • China – Home-grown colorectal cancer drug approved in China
  • Europe – Change in the classification of certain glucosamine products
  • USA – FDA on Pace for Record Generic Approvals in 2018
  • Europe – Janssen bags new EU approval for Darzalex
  • Europe – Sanofi’s Cablivi cleared for rare bleeding disorder
  • Europe – Chinese Pharmacopoeia in Strasbourg to illustrate new regulation for excipients
  • Europe – NICE says ‘no’ to Gilead’s Yescarta in draft guidelines
  • Europe – NICE u-turn recommends Ipsen’s Cabometyx for kidney cancer
  • USA – Limit Placebo Use in Cancer Clinical Trials, Says FDA
  • Europe – New EU Task Force Unveils Two-Year Regulatory Roadmap to Mitigate Medicine Shortages
  • USA – Ascend Therapeutics Draws FDA Untitled Letter Over Estrogel Claims
  • Europe – EU approves first CAR-T therapies
  • USA – FDA Singles Out Three Drug Substances to Not be Compounded
  • Asia – Six Asian Firms Blocked for Refusing FDA Inspections
  • USA – FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions
  • USA – Roche, Novo Nordisk and Merck Weigh in on FDA Draft Guidance on Assessment of Pressor Effects
  • USA – Drug Prices in Ads: Senate Passes Amendment
  • USA – FDA Recommends Use of Placebo Only in Certain Oncology Trials
  • USA – Researchers Question Level of Patient Input in Clinical Outcome Assessments in FDA Compendium
  • Europe – Esmya: new measures to minimise risk of rare but serious liver injury
  • Europe – ICH M9 on biopharmaceutics classification system based biowaivers – Step 2b – First version
  • Europe – Brexit Impact: EMA Suspends Publication of Clinical Trial Data
  • USA – Judge Denies J&J Motion to Dismiss Pfizer Lawsuit Over Remicade
  • Europe – Effective Protection Period for Medicines has Declined in Last Decade, EC Report Finds
  • USA – FDA Approves First Generic Drug to Receive CGT Designation
  • USA – FDA Launches New Medication Guide Database
  • USA – FDA Finalizes ICH Guidance on Elemental Impurities
  • Europe – EC Drafts Guideline on GCP for Advanced Therapies
  • Europe – EMA: More Staff Than Anticipated Quit Ahead of Brexit Relocation
  • Europe – EMA Consults on Genetically Modified Cell Products Guideline
  • Catégorie : International
    • International – FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs
    • International – Médicaments : quelle(s) réalité(s) ?
    • International – Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas
    • International – WHO Revises Guidance on QMS Requirements for National Inspectorates
    • International – Top 9 Companies in the Diagnostics Market
    • International – Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States
    • International – EU-U.S. trade talks: milestone reached in mutual recognition on pharmaceuticals
    • International – WHO’s five-year plan to help build effective and efficient regulatory systems
    • International – WHO Updates Lists of Essential Medicines, Diagnostics
    • Europe – The impact of Mutual Recognition Agreement between the European Union and the United States as of 27 June 2019 : Questions & Answers
    • International – WHO develops classification system for protecting efficacy of antibiotics
    • International – ICH Adds Four New Regulatory Observers
    • International – ICH guideline E8 (R1) on general considerations for clinical studies : Step 2b
    • International – WHO Outlines Process to Designate Regulators as WHO-Listed Authorities
    • International – L’OMS adopte une résolution sur la transparence du marché des médicaments
    • International – Study quantifies drug revenue invested in R&D
    • International – WHO Stresses Role of GMP in Combatting Antimicrobial Resistance
    • International – Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations
    • International – ICH Drafts Revised Guideline on General Considerations for Clinical Studies
    • International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections
    • International – WHO Seeks Consultant to Help Cambodia Strengthen Drug Regulation
    • International – ICH Updates: What’s Coming in 2019 and Beyond
    • International – Guideline : General Principles for Planning and Design of Multi-Regional Clinical Trials E17
    • International – EU files WTO dispute with Turkey over pharma laws
    • International – Big Pharma come together for better drug side effect detection
    • International – ICH guideline E19 on optimisation of safety data collection
    • International – Guideline for Elemental Impurities Q3D(R1)
    • International – WHO Consults on QMS Guideline for Regulators
    • International – WHO Warns of Falsified Leukemia Drug in Supply Chain
    • International – Differences and similarities between FDA 21 CFR Part 820 and ISO 13485
    • International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections
    • International – NICE and Canadian counterpart to offer joint advice service
    • International – Biosimilar use may increase with scrutiny of high drug prices
    • International – Drug price disclosures could influence consumer thinking, study finds
    • International – Industry Comments on ICH Product Lifecycle Management Guideline
    • International – ICH Offers Updates on Guidelines, Working Groups
    • International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments
    • India – India’s CDSCO Seeks Feedback From Users of Online Drug, Medical Device Portals
    • International – FDA to Follow EMA With Move From London to Amsterdam
    • International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States
    • International – Mylan recalls 15 lots of blood-pressure drug containing valsartan
    • International – Pfizer to increase some drug prices in 2019
    • International – EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections
    • International – Australia and Canada Extend Mutual Recognition Agreement to APIs
    • International – GSK’s says depot HIV injection works over three years
    • International – Valsartan prices double after recall
    • India – India Hews Closely to WHO GMP Guidelines in Planned Changes to Schedule M
    • International – EMA Takes Further Action in Ongoing Review of Tainted ‘Sartans’
    • Afrique – Les faux médicaments, un fléau pour l’Afrique
    • International – Innovative Designs in Early Phase Oncology Studies
    • International – Scientists Have Engineered a Potential New Class of Antibiotic That Can Kill Superbugs
    • International – Updated: FDA, Health Canada and EMA Spot Second Impurity in Valsartan
    • Emerging Market Access Strategy in the Pharmaceutical Industry the example of Thailand – by Thomas Dreyfuss
    • International – Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal
    • International – WHO Opens Consultation on New Biosimilar Q&A
  • Catégorie : France
  • Catégorie : Europe
  • Catégorie : Amériques
  • Catégorie : Asie-Pacifique
  • Catégorie : Découverte
• Catégorie : Dispositifs Médicaux
  • USA – Researchers Find 15% of Trials Could be Replicated Using Real World Data
  • USA – FDA Clears First Rapid Diagnostic Test for Ebola
  • Inde – Nouvelle définition des dispositifs médicaux pour inclure les nébuliseurs et les seringues
  • Europe – MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
  • USA – CDRH Proposed Guidances for Fiscal Year 2020
  • Europe – EC Unveils First Notified Body Designation Under IVDR
  • USA – FDA Issues Two Final Guidances on Guidewires, Catheters and Delivery Systems
  • USA – FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials
  • UK – Medical devices regulation in the event of no deal
  • Europe – MDCG 2019 -10 : Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
  • Brazil – Brazil’s ANVISA approves formal regulations for custom-made medical devices
  • Europe – Regulatory Strategies for EU MDR and IVDR Implementation
  • USA – FDA to Further Investigate Implantable Devices Containing Certain Metals
  • USA – FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software
  • USA – US FDA updates guidance for telehealth and digital products qualifying as medical devices
  • Europe – MDGC Guidances
  • USA – EPA requires firms to provide info on EO emissions
  • Europe – TÜV Rheinland Becomes 5th Notified Body Designated Under MDR
  • USA – Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
  • USA – Clinical Decision Support Software
  • Australia – Australian regulatory action on breast implants and breast tissue expanders
  • China – Graphene-Based Artificial Throat Could Help Mute People Speak
  • USA – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
  • India – India To Enhance Oversight Of Medical Devices
  • Europe – Fitbit Users in Europe Can Now Monitor their Heart Rhythms for Irregularities
  • USA – Electronic Device Submissions: FDA Drafts Guidance
  • UK – MHRA: Role of UK Responsible Person and Importer are the same
  • China – China Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme
  • USA – Patient Engagement in Device Trials: FDA Drafts Guidance
  • Europe – 27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR
  • USA – FDA Details Long-Awaited Standards Accreditation Pilot in New Draft Guidance
  • USA – First MDR Certificate Issued for Class III Device
  • USA – CDRH Takes First Step to Operationalize New Safety and Performance Based Pathway
  • USA – Safer Technologies Program for Medical Devices
  • USA – Not Quite a Breakthrough Device, FDA Introduces New Safer Technologies Program
  • UK – Regulating medical devices in the event of a no-deal Brexit
  • UK -Businesses supplying medicines and medical devices: preparing for Brexit
  • Europe – New details from European Commission on Expert Panels under MDR, IVDR
  • USA – CDRH releases Four Final 510(k) Guidances
  • Europe – EC Explains New MDR, IVDR Rules for Designating Expert Device Panels
  • Europe – EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante
  • Europe – European MDR covers cosmetic and aesthetic products: Are these firms ready?
  • USA – Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity
  • USA – FDA issues final guidance on de novo approvals
  • USA – De Novo Requests: FDA Finalizes Three Guidances
  • USA – Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations
  • USA – Humanitarian Use Device (HUD) Designations
  • USA – New Report Compares FDA Quality System Requirements With ISO 13485:2016
  • Europe – Implementation of IVDR and MDR Into National Legislation
  • UK – Deal or no deal: Key Brexit-related issues for medical device, IVD sectors
  • Mexico – Mexican regulators to require online submission of medical device import permit applications
  • Europe – AMDR comments on issues of EU single-use medical devices specifications
  • USA – How to produce more medical devices for kids
  • Europe – Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit
  • Europe – No-deal Brexit, more likely than not: Key issues for medical device, IVD sectors
  • China – Chinese NMPA publishes UDI system rules for medical device registrants
  • Germany – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn
  • Australia – Medical device incident reporting (MDIR) guide
  • Australia – TGA’s UDI Proposal Gets Broad Industry Support
  • International – Researchers develop ‘highly sensitive’ breast cancer blood test
  • UK – Screening test may prompt earlier ovarian cancer detection
  • Denmark – Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance
  • Europe – IMQ becomes fourth Notified Body designated to MDR
  • Europe – Gestion du rapport bénéfice/risque des dispositifs médicaux – Projet de norme PR XP S99-223
  • Europe – New IMDRF recommendations for Conformity Assessment Body recognition requirements
  • Singapore – Regulatory chart: Medical device & IVD registration in Singapore
  • Europe – DEKRA accredited under the MDR
  • UK – New MDR Conformity Assessment Routes guide
  • Switzerland – L’ON SUISSE QS ZÜRICH AG jette l’éponge
  • USA – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (Draft Guidance)
  • USA – US FDA finalizes post-market safety reporting guidance for combination products
  • USA – Examining US FDA criteria for medical device cybersecurity and risk management
  • USA – U.S. asks E.U. to delay MDR/IVDR by 3 years
  • A Wearable Device Is Changing the Way Clinicians Manage Parkinson’s Patients
  • Australia – Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?
  • UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario
  • Australia – Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)
  • China – US-China trade war unlikely to shift manufacturing to US
  • Australia – European implementation of Medical Device and IVD Regulations – Implications for Australia
  • Australia – Thermography should not be relied on for early detection of breast cancer
  • USA – FDA Finalizes Guidance on Metal Expandable Biliary Stent 510(k)s
  • Brazil – Brazil’s ANVISA now requires electronic submissions of medical device FSCAs
  • Australia – Australian TGA finalizes medical device and IVD cybersecurity guidance
  • USA – FDA Recognizes Standards for Medical Device Interoperability, Safety Assurance Cases
  • USA – Designing a Drug-Delivery Device? Read This First
  • USA – Bioabsorbable Materials 101
  • USA – FDA Finalizes Combo Product Postmarket Safety Reporting Guidance
  • USA – Bluetooth-enabled implant may be future of medication management
  • Australia – Cyber security for medical devices and IVDs
  • Australia – Breast implants and anaplastic large cell lymphoma
  • USA – Updated Fundamentals of US Regulatory Affairs Book
  • China – Chinese regulators preparing medical device UDI pilot
  • Europe – European Commission clarifies medical device vigilance requirements
  • Europe – State of flux: European Notified Body numbers decrease further ahead of MDR, IVDR
  • USA – 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design
  • USA – First FDA-Developed Medical Device Development Tool Receives Qualification
  • UK – The Human Medicines and the Medical Devices Regulations 2019
  • Europe – Why Industry Anticipates a ‘Cliff-Edge’ Scenario With EU MDR/IVDR
  • USA – AdvaMed asks FDA to revise draft guidance on medtech inspections
  • Europe – Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
  • Europe – Call for applications: observers for the nomenclature sub-group of the medical device coordination group
  • UK – UL UK to Sunset Operations Under EU’s Medical Device Directive
  • UK – Device for preventing and relieving pain of cluster headaches approved by NICE in draft guidance
  • China – Chinese NMPA update: eRPS, predicate device data, technical review guidelines
  • France – Liste des DM génériques remboursable nécessitant un code d’identification individuel : démarche simplifiée
  • Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health
  • Spain – Spanish NB Applies for EU MDR Designation
  • USA – US FDA issues final rule for appealing medical device regulatory decisions
  • Europe – Medical Devices: Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
  • Europe – MDCG 2019-7 : Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’
  • South Korea – MFDS rolls out new regulation for IVD devices
  • Europe – EC Seeks Feedback on New and Revised MDR/IVDR Standards
  • Canada – Pre‐market Requirements for Medical Device Cybersecurity : Guidance Document
  • UK – New prostate cancer test could diagnose five years earlier
  • USA – US FDA shakes up Medical Device Reporting Program
  • USA – CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers
  • Maylasia – Process chart: Medical device & IVD registration requirements in Malaysia
  • UK – EU Exit preparedness
  • Europe – European Commission forecasts potential supply disruptions due to MDR, IVDR
  • USA – CDRH Drafts Clinical Recommendations for Prostate Tissue Ablation Devices
  • Australia – TGA Creates Guidance on Device Standards for Quality Management Systems
  • Europe – Notified Body Survey Offers New Data on EU Medical Device Certificates
  • Europe – European Commission Expert Panels on Medical Devices and In Vitro Diagnostic Devices
  • USA – FDA Releases 20 Years of Data on Medical Device Adverse Event Reports
  • UK – New implant recommended by NICE for uveitis
  • Europe – EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays
  • Australia – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019
  • Canada – Health Canada Consults on New Proposed Device Regulations
  • Europe – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’
  • Brazil – Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices
  • International – Real-World Data Collection – What Role Could Your Device Play?
  • Europe – EC Cautions on MDR/IVDR Impact on Device Availability
  • UK – LRQA winding down Notified Body services for Medical Devices and IVDs
  • USA – FDA Received 6,000 Reports About Essure in 2018
  • Europe – May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says
  • USA – CDRH Drafts Guidance on Mouse Embryo Assays
  • UK – Biggest Regulatory Challenge is Software Safety
  • Europe – EC Selects Four UDI Issuing Entities
  • Japan – Japanese firm develops assay with integrated circuit for cancer detection
  • Europe – EU awards Active Implants a grant of around $6.8M
  • UK – UK NB Will Not Apply for EU MDR/IVDR
  • Europe – M2M Data Exchange Services Definition (v1 29 May 2019)
  • Europe – M2M data exchange services and entity models introduction (v1 29 May 2019)
  • Europe – EUDAMED UDI Device Data Dictionary
  • Europe – Brexit sans accord: la Commission européenne fait le point sur les préparatifs avant le Conseil européen (article 50) de juin
  • China – China’s NMPA reports major decrease in medical device approvals
  • USA – 11 Medical Devices Recently Approved by FDA
  • Europe – Lignes directrices de NICE sur les meilleures pratiques avec le PICO[TM]
  • Europe – Nouvelle Version 1.22 du Manuel Produits Frontière est sortie
  • USA – The Best Predicate or the Worst?
  • USA – FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
  • Spain – Spain Introduces Portal for Electronic Reporting of Medical Device Adverse Events
  • Europe – MDCG 2019-6 : Requirements relating to notified bodies – Questions and answers
  • USA – NESTcc Taps Apple Watch as First Wearable Project
  • France – Carmat va reprendre la production de ses coeurs artificiels pour les essais cliniques
  • China – Chinese NMPA update: ePRS, predicate device data, technical review guidelines
  • Europe – Draft guideline on quality requirements for medical devices in combination products
  • Europe – EU MDR: Are Your Labels Compliant?
  • International – Roche launches first IVD test for detecting ROS1 protein in cancers
  • Europe – Spanish NB Bows Out Ahead of EU MDR
  • USA – GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements
  • Europe – Guidelines for Member States on the use of Data Exchange solutions
  • Europe – Eudamed Data Exchange Services and Entity Models Introduction
  • Europe – EU Device Industry Groups Call to Accelerate MDR Implementation
  • USA – NESTcc Advances Data Quality and Study Design Frameworks
  • China – China’s NMPA Strengthens Oversight of Imported Medicinal Materials
  • International – IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices
  • Europe – Le temps presse pour les fabricants de DM de classe I
  • USA – US FDA calls for test cases for its SaMD Pre-Cert Program
  • USA – Experts Discuss CDRH Proposals That May Require New Authorities
  • USA – FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
  • USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
  • USA – FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
  • USA – Developing a Wearable Display for Surgeons
  • USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming
  • Europe – May 2019 Regulatory Roundup: Europe on the verge of MDR
  • Europe – Changements significatifs dans le cadre de la période transitoire (article 120) : Guide GMED pour l’interprétation
  • Europe – TÜV SÜD Becomes Second NB to be Designated Under EU MDR
  • USA – AI could spot lung cancer before radiologists
  • India – India Assigns Risk Categories to Imaging Scanners, Other Recategorized Devices
  • USA – FDA provides updates on postmarket safety review of Bayer’s Essure
  • Canada – Performance Standards for the Fees in Respect of Drugs and Medical Devices Order
  • Europe – Is Your Testing Program Ready for the EU MDRs?
  • Europe – Évaluation biologique des dispositifs médicaux — Partie 23 : Essais d’irritation PR NF EN ISO 10993-23 – Enquête Publique – Date de clôture : 05/07/2019
  • International – Connected medical device design for the Internet of Things
  • USA – Final FDA Q-Submission guidance includes medical device cybersecurity coverage
  • USA – FDA Finalizes Two Guidances to Align X-Ray Imaging Devices With International Standards
  • USA – FDA Finalizes Q-Submission Feedback and Meetings Guidance
  • USA – FDA to End Alternative Summary Reporting for Devices
  • Europe – EC Explains What UDI Information to Provide for Eudamed
  • USA – FDA Publishes List of Priority Patient Preference Areas for Medical Devices
  • UK – New NICE guideline to help spot suspected neurological conditions
  • Europe – Widespread Concern Over Europe’s Uncertain Regulatory Future Highlights Region’s Importance
  • Brazil – Spring 2019 medical device regulatory recap: Brazil
  • Canada – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing : Publication of the Guidance Document
  • USA – Industry raises concerns with FDA guidance on post-inspection feedback
  • International – Trends in Healthcare and Medical Device Manufacturing
  • International – 9 human factors pitfalls to avoid for safer orthopedic surgical devices
  • Europe – Brexit update: Extension to October 31, 2019
  • Europe – New long-lasting implant to treat opioid dependence
  • USA – FDA Finalizes Guidance on Convenience Kit UDI Marking
  • USA – FDA Finalizes Guidance on UHMWPE in Orthopedic Devices
  • International – IMDRF Takes Another Stab at IVDs, MDSAP
  • USA – FDA Finalizes Guidance on Non-Clinical Bench Performance Test Reports for Device Submissions
  • Switzerland – Swiss Medtech : L’incertitude juridique paralyse l’industrie de la technologie médicale
  • USA – FDA Drafts Guidance on Adjusting for Covariates in Randomized Trials
  • China – China Starts Clampdown on Unregistered Devices, Threatens Severe Punishments
  • USA – Could Secret Sales Bar Your Ability to Patent a Medical Device?
  • USA – FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products
  • USA – There’s a New Weight-Loss Device in Town and TPS Is Its Name
  • USA – CDRH : New steps to help reduce risks associated with surgical staplers for internal use and implantable staples
  • USA – FDA : New steps to strengthen the process of initiating voluntary recalls
  • USA – FDA permits marketing of first medical device for treatment of ADHD
  • Japan – Japanese regulators extend participation in Medical Device Single Audit Program (MDSAP)
  • Europe – TEAM-NB : Survey on NBs applications against IVD new regulation
  • Europe – TEAM-NB : Position Paper on Spinal Classification per the MDR
  • USA – CDRH Draft Guidance Tackles Nitinol Devices
  • USA – CDRH Drafts Guidance on Quantitative Imaging
  • Europe – MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR
  • USA – Experts Tell Device Companies Not to Fret Over QMS Transition
  • Europe – Investigational site and personnel selection for medical device clinical studies
  • USA – FDA stops all US sales of Surgical mesh intended for transvaginal repair of pelvic organ prolapse (POP)
  • Europe – EU Device Coordination Group Offers Eudamed Guidance
  • Europe – RDM et RDMDIV : les fabricants dans l’attente des organismes notifiés
  • Europe – European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit
  • USA – Purified Fat Could Be an Alternative to Breast Implants
  • USA – FDA Reclassifies Certain Device Accessories to Class I
  • USA – FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion
  • Europe – Préparation à un Brexit sans accord: la Commission européenne dresse le bilan des préparatifs et fournit des orientations pratiques pour garantir une approche coordonnée au niveau de l’UE
  • USA – FDA Removes 9% of Medical Device Registrations from Database
  • UK – Virtual manufacturing of medical devices
  • UK – ‘Use greener asthma inhalers’, encourages NICE
  • USA – FDA’s De Novo Program Gains Momentum
  • USA – US FDA identifies hundreds of device types affected by sterilization facility closures
  • Australia – An Action Plan for Medical Devices
  • International – IMDRF Works to Speed Entry of Devices Across Multiple Countries
  • Europe – COCIR Pushes to Harmonize Device Standards
  • Europe – Comment protéger le logiciel d’exploitation d’un DM ?
  • Japan – Japanese regulators increase medical device registration fees for 2019
  • USA – US FDA targets safety of materials used in medical devices
  • USA – FDA wants public input on AI-enabled device regulation
  • USA – FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD
  • Europe – MedTech Europe Flags MDR/IVDR ‘Burning Points’
  • Ireland – No-deal Brexit could affect accessibility of 40% of devices in Ireland
  • Europe – GDPR and human factors studies for medical devices: Key issues for manufacturers and sponsors
  • USA – FDA Proposes Radiological Health Deregulatory Action
  • USA – FDA Classifies IVDs for Bacillus Detection
  • UK – NICE backs PredictImmune’s IBD prognosis test
  • UK – BREXIT : où en est-on ?
  • UK – BREXIT : Fiches d’information et FAQ
  • USA – FDA Drafts Guidance on Inspections of Medical Device Establishments
  • Europe – GMDN Agency Welcomes Alignment of Medical Device Database to Global Nomenclature
  • USA – CDRH Proposes New IMDRF Work Item on Standards
  • USA – FDA Panel Recommends New Postmarket Requirements for Breast Implants
  • Europe – MDIVD : Get ready for the new regulation
  • Europe – EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates
  • Europe – EU MedTech Industry Signals Need for Harmonized Approach to Cybersecurity
  • China – Hong Kong Proposes Overhaul of Guidance on Medical Device Responsible Persons
  • Europe – European Panel Offers Advice on Complex Drug Trials
  • Europe – MHRA Guidance on a No-Deal Brexit
  • Europe – European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario
  • Europe – Brexit delay: Reduced risk of no-deal withdrawal for medical device manufacturers?
  • Europe – EU MDR/IVDR Coordination Group Urges Exemption Clarification
  • USA – FDA’s OCP Works to Modernize Review Functions
  • Europe – Rationalize Your Labeling Approach to Prepare for the EU MDRs
  • Europe – Dutch regulators weigh in on no-deal Brexit impact for medical device companies
  • Europe – EU Publishes First Corrigenda for MDR, IVDR
  • UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices
  • USA – CDRH to Review Materials Used in Medical Devices
  • USA – FDA Wants to Take a Hard Look at Medical Device Materials
  • Australia – Australian medical device regulators preparing Brexit contingency plans
  • Europe – Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)
  • USA – CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials
  • Canada – Health Canada Begins Release of Clinical Data on Drugs and Devices
  • USA – CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders
  • USA – CDRH Qualifies 3rd Medical Device Development Tool
  • USA – Top 10 Patient Safety Concerns in 2019
  • Europe – Medical devices: the shift from embedded to connected
  • Europe – EUDAMED : Draft Functional specifications
  • Europe – Première version des spécifications communes pour consultation publique des Etats membres de l’UE
  • USA – Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines’ Initial Release
  • Italy – Italian medical device nomenclature to be adapted for Eudamed database
  • Australia – TGA Proposes 5 Medical Device Classifications in Line With EU MDR
  • USA – MDIC Works to Standardize Oversight of NGS-based Assays
  • USA – FDA proposes exempting some flow cytometers from 510(k) requirements
  • UK – Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal
  • USA – CDRH Classifies Software App for Contraception into Class II
  • USA – Gottlieb to Resign as FDA Commissioner
  • Israel – Startup develops electrospinning device for wound treatment
  • Europe – EUDAMED – la nomenclature CND va remplacer celle du GMDN
  • USA – Capturing Device Identifiers for Non-Sterile Orthopedic Implants at Point of Care
  • USA – FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures
  • Brazil – Notification pathway for Class I devices nearing publication in Brazil
  • International – Innovation, Personalization Power 3D-Printed Medical Device Market
  • China – Chinese scientists develop nanogenerator for cancer drug delivery system
  • UK – Parallel imports of medical devices
  • Europe – No-deal Brexit: Key Questions for Medical Device Companies
  • USA – FDA warns consumers to avoid using thermography devices to detect breast cancer
  • USA – CDRH Issues Guidance on Brain-computer Interface Devices
  • USA – Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect
  • Europe – U.S. and EU Agree to Work Together on UDI Standards
  • India – Healthcare needs a unified regulator for drugs and devices, advise experts
  • USA – CDRH Classifies Auto Titration Device for Oral Appliances
  • Switzerland – Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) – updated information
  • USA – FDA issues draft guidance on non-binding feedback on inspections
  • USA – CMS now covers Clarify’s phototherapy psoriasis treatment
  • Australia – TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices
  • USA – Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh
  • India – India to Treat Implants and Imaging Equipment as Drugs From April 2020
  • Australia – Australia Proposes to Reclassify Spinal Implants in Line With EU MDR
  • UK – Medical devices: information for users and patients
  • USA – Exemptions for Unclassified Devices: CDRH Updates Guidance
  • USA – Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds
  • USA – 7 Pro Tips for New and Aspiring Roboticists
  • USA – Combo Product Reviews: FDA Drafts Guidance
  • USA – Behind the Invention: Wearable Artificial Kidney
  • UK – New UK conformity mark to replace the CE mark in a « no-deal » scenario
  • USA – CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions
  • Europe – Another Reason to Update Your Biocompatibility Approach: EU MDRs
  • Europe – Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer
  • USA – GS1 Guidance to Support Point-of-Care Scanning of UDI Data for Implantable Devices
  • USA – FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices
  • Canada – Health Canada Seeks to Better Define Regulatory Requirements for SaMD
  • Europe – US, EU Pledge to Cooperate on UDI Specifications
  • China – Hong Kong Medical Device Regulatory Update: IVD listings, acceptance period for NMPA approvals
  • China – NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software
  • USA – Medtronic Launches Mazor X Stealth Edition for Robotic-Assisted Spine Surgery
  • USA – Boston Sci’s BPH Treatment Effective in Preserving Sexual Function After 4 Years
  • USA – Integrated Device Design Critical to Rapid Medical IoT Development
  • USA – 510(k) Modernization: FDA Floats Need to Pursue New Authority
  • Europe – Survey Highlights Looming Shortfall of IVDR-designated Notified Bodies
  • USA – After the Product-Centric Medical Industry – What’s Next?
  • UK – UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit
  • 3D Printing Prosthetics and Implants With Precision
  • USA – CES 2019 : revue des technologies qui vont stimuler l’essor du numérique en santé
  • USA – Applied Tissue Technologies’ negative-pressure dressing gets FDA nod
  • USA – CDRH Revamps 510(k) Clearances With ‘Safety and Performance Based Pathway’
  • Europe – Survey on NBs applications against IVD new regulation
  • International – 11 innovative medical devices you need to know from 2018
  • Europe – Are Wearables Medical Devices Requiring a CE-Mark in the EU?
  • India – India’s health ministry accepts eIFU for medical devices
  • Europe – EU Lists First Notified Body Under MDR
  • USA – Device makers seek transparency on Breakthrough Devices Program
  • Europe – Is Progress on MDR and IVDR Happening Fast Enough?
  • USA – Wearable device studied for detection of pediatric anxiety, depression
  • USA – US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase
  • Europe – Latest Brexit Agreement Voted Down by British Parliament
  • USA – FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices
  • UK – Brexit: 10 key changes to UK product safety laws?
  • USA – Impact of the USMCA on the Medical Device Industry
  • Canada – Canada Completes Transition to MDSAP
  • USA – Abbott Snags FDA Approval for Neonatal Heart Device
  • Europe – Kheiron Medical launches trial of AI algorithm for breast cancer Dx
  • Canada – AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices
  • China – China’s NMPA Launches Voluntary Device Master File Process
  • USA – Wearable dialysis system gains breakthrough designation from FDA
  • USA – Seizure Monitoring Smartwatch Cleared for Use in Children
  • USA – FDA to Test PreCert De Novo Requests Under Pilot
  • Europe – MDR & NBs – L’inquiétude grandit (The worry is growing)
  • Europe – Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation
  • Australia – Australia Explores Adopting UDI System
  • USA – FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’ Corrections
  • Australia – TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity
  • USA – MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes
  • USA – What Will 2019 Bring for Medtech?
  • South Korea – S. Korean devicemaker debuts AI-based diagnostics platform
  • Europe – European Regulators Publish UDI Guidance
  • USA – Medical Device QMS Harmonization: US Considers Aligning to ISO 13485
  • China – China FDA Reorganization: Impact for medical device registrants
  • International – Predict and Prevent: The Emergence of Real-Time Sensor-Based Care
  • USA – Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny
  • USA – FDA Reclassifies Some ECT Devices
  • Canada – Health Canada Details Medical Device Action Plan
  • Europe – Brexit Contingency Action Plan Issued by European Commission
  • USA – US Regulatory Landscape for Medical Devices: A Year in Review and a Look Ahead
  • USA – US FDA Finalizes Guidance on Breakthrough Medical Device Pathway
  • USA – FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance
  • USA – Medical device industry regulation is changing: What you need to know
  • Canada – Health Canada Setting Pre-market Medical Device Cybersecurity Requirements
  • USA – Considering Old and New 510(k) Predicates
  • USA – FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices
  • USA – FDA Finalizes Rule to Simplify Medical Device Classification Procedures
  • USA – FDA Finalizes Guidance on Changes to Device Manufacturing Sites
  • Europe – La Ph. Eur. révise le chapitre général sur la spectrophotométrie infrarouge
  • Europe – Révision : guideline sur la validation des systèmes informatisés
  • Europe – Rushing to EU MDR deadline could disrupt supply, delay approvals
  • UK – New NICE standards to improve digital health tech uptake
  • UK – PredictSURE IBD gains CE mark, set for UK and EU launch
  • UK – Scientists develop revolutionary tech to improve prostate cancer detection
  • Australia – Regulation of Software as a Medical Device
  • Europe – EU Commission adopts REACH nano changes
  • USA – FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
  • Europe – Brexit Update: New Notified Body Designated in The Netherlands
  • Canada – Canada’s MDSAP Transition Deadline Fast Approaching
  • USA – FDA Drafts Guidance on Oncology Companion Diagnostics
  • USA – Benefits of ERP in an FDA-Regulated Environment
  • Europe – Evaluations conjointes des organismes notifiés dans le secteur des dispositifs médicaux : état des lieux
  • USA – FDA Proposes Rule to Implement New De Novo Classification Process
  • UK – Are Smaller Hip Implants in Older Patients More Cost Effective?
  • Europe – Déployer des dispositifs médicaux IoT en toute confiance
  • Canada – Health Canada to Release Action Plan for Medical Devices Amid Reports of Faulty Implants
  • USA – Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions
  • China – What does the U.S.-China trade war mean for medical device companies?
  • China – Hong Kong Regulators Launch Online IVD Classification Tool
  • Europe – Diabeloop Is 2nd to Win CE Mark for Artificial Pancreas System
  • Germany – New Virtual Surgical Simulator Debuts in Germany
  • USA – FDA issues revised draft guidances for blood glucose monitors
  • UK – Concept Device Designed to Tame Menopausal Hot Flashes
  • USA – First Device Cleared for the Prevention of Cluster Headache
  • USA – FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems
  • USA – CDRH Redrafts Policies on CLIA Waivers for IVDs
  • Canada – Health Canada Proposes Changes to Priority Review Requests for Medical Devices
  • USA – Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators
  • Europe – European MDR Transition: Update at the Halfway Point
  • USA – New steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
  • USA – Does More FDA Oversight Equal Better Compliance?
  • Europe – European Medical Device Regulation: The Compliance Advantage
  • Europe – Diagnostics Are Helping Counter Antimicrobial Resistance, But More Work Is Needed
  • USA – CDRH Touts Uptick in Foreign Device Inspections
  • Europe – 7 Things That Have Medtech Companies Thankful in 2018
  • USA – Intracranial Hemorrhage Detection Software Receives FDA Clearance
  • USA – FDA – MD Safety Action Plan to enhance post-market safety : Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health
  • International – Google’s Verily spikes glucose-sensing lens project with Novartis’ Alcon
  • USA – FDA Proposes New Framework on Prescription Drug-Related Software
  • Europe – Is Progress on MDR and IVDR Happening Fast Enough?
  • Europe – Draft Brexit Agreement’s Implications for Medical Device Sector
  • Europe – BSI achieves Designation for its Netherlands Medical Devices Notified Body
  • How Digital Health Technologies Could Make a Difference
  • Europe – NEW REGULATION – GUIDANCE
  • Israel – How One Digital Health Company is Outsmarting Diabetes
  • USA – Benefits of ERP in an FDA-Regulated Environment
  • UK – Abbott’s wearable glucose monitor to be available across England
  • USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs
  • Australia – Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018
  • Malaysia – Malaysian Regulators Launch New Medical Device Databases
  • USA – Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating
  • USA – Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver
  • China – Chinese Regulators Revamp Innovative Medical Device Review Process
  • USA – UL Wades into Cybersecurity of Connected Medical Devices
  • USA – US FDA Updates UDI Policy for Direct Marking of Medical Devices
  • Europe – MDR and IVDR Implementation: Update from the European Commission
  • Europe – Manual on Borderline and classification in the Community Regulatory Framework for Medical Devices
  • USA – FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
  • USA – Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years
  • USA – CDRH Issues Final Orders on Medical Devices for Insulin Adjustment, Drug Screening
  • USA – FDA Withdraws Proposed Rule on Electronic Labeling for Certain Devices
  • USA – FDA isn’t doing enough to prevent medical device hacking, HHS report says
  • USA – US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot
  • Europe – EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns
  • USA – Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?
  • USA – FDA Issues New Classification for Implantable Bone Conduction Hearing System
  • France HEMARINA named National French Start-Up of the Year by EY
  • USA – CDRH Works on Clinical Objectivity in Patient-Reported Outcomes
  • USA – How electronic skin tech is improving home wearable devices
  • USA – Top 10 Medical Innovations for 2019
  • USA – First Version of NEST to Launch in 2019
  • UK – Decide if your product is a medicine or a medical device
  • USA – US FDA Publishes Highly Anticipated Update to Medical Device Cybersecurity Recommendations
  • South Korea – South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO 13485:2016
  • Europe – MDCG WORKING GROUP : Notified bodies, UDI, …
  • USA – Device Firms to Inform New FDA Framework on Servicing
  • USA – UDI: 5 Opportunities You May Not Have Considered
  • USA – CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices
  • Australia – TGA Proposes Regulation on IVD Companion Diagnostics
  • International – Artificial Intelligence : the Future in Healthcare and Medical Device Manufacturing
  • USA – FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews
  • International – Novartis, Foundation Medicine collaborate on companion diagnostics
  • Italy – Valeritas launches wearable insulin delivery device in Italy
  • Europe – EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes
  • International – 25 Medtech Startups You Need to Know
  • USA – 7 electronic design problems that boost medical device costs
  • USA – Your device design looks great. Now how do you get reimbursement?
  • USA – FDA Tweaks List of Recognized Consensus Standards for Devices
  • Europe – European Commission Offers Guidance on UDIs
  • Europe – EU Releases Working Plan to Implement MDR/IVDR
  • USA – Cybersecurity: FDA Spells Out Updated Premarket Policies
  • USA – CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator
  • UK – Regulator seizes almost 10,000 unsafe STI + HIV test kits
  • USA – US FDA Clarifies Human Subject Requirements for Clinical Investigations
  • USA – Doctors to monitor hip, knee surgery patients using Apple Watch
  • China – Scientists create color-changing lenses for delivering eye treatments
  • Australia – Patient implant cards and consumer device information leaflets
  • USA – CDRH Drafts New Framework to Create a Pediatric Device Safety Network
  • USA – FDA Warns of Cyber Vulnerability in Medtronic Implantable Cardiac Devices
  • Europe – Medical devices: EU regulations for MDR and IVDR
  • Canada – Health Canada: MDSAP Could Force Some Manufacturers Out
  • Canada – Health Canada Developing MDL Policies for 3D-Printed Medical Devices
  • Europe – KPMG and RAPS: Medical Device Companies Under-prepared for European MDR
  • USA – Cybersecurity: CDRH to Update 2014 Premarket Policies
  • USA – AdvaMed Backs Wright Medical in Hip Liability Case
  • International – Body Vision Releases LungVision for Early-Stage Lung Cancer Diagnostics
  • USA – CDRH Works to Develop Proposed De Novo Regulation
  • UK – Notify MHRA about a clinical investigation for a medical device
  • USA – Continuous Quality: FDA’s Goal for the Case for Quality Program
  • USA – Eximo Medical’s Atherectomy Laser Cleared by FDA
  • China – Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List
  • USA – Self-Fitting Hearing Aid Receives Nod from FDA
  • UK – Roche CoaguChek device producing inaccurate results
  • USA – US FDA’s Medical Device Division Lays Out Regulatory Guidance Plans for 2019
  • UK – UK’s NICE recommends Procept’s robotic system for BPH
  • Europe – Abbott’s glucose monitoring system with real-time alarms wins EU nod
  • Europe – The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across Europe.
  • Europe – TÜV SÜD Survey: Expected Shortage of Notified Bodies Under EU MDR/IVDR
  • USA – CDRH Offers Look at Upcoming Guidance Documents in FY 2019
  • USA – US FDA Launches Pilot to Expand Special 510(k) Market Pathway
  • Europe – Digital health projects win £17 million
  • USA – Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved
  • USA – Gottlieb Defends Digital Health Approach
  • USA – Philips Unveils Augmented Infant Resuscitator for Safe Rescue of Asphyxiated Newborns
  • USA – IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways
  • USA – FDA Reduces Regulatory Burden for Female Condoms
  • USA – US Regulators Update Policies for Medical Device Voluntary Consensus Standards
  • Europe – Effects of “No Deal” Brexit for Medical Device Sector
  • USA – FDA Reveals Vision for the Transition to ISO 13485
  • USA – Intuitive Surgical Could Help Usher in a New Era for Medtech
  • USA – Paladin Carotid PTA Balloon with Embolic Protection Filter Cleared by FDA
  • USA – FDA Clears Pure-Vu Slim Sleeve to Clean Out Colons Using Slim Colonoscopes
  • USA – Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance
  • USA – Device Makers Call for Changes to FDA’s Biliary Stent Guidance
  • UK – Notify MHRA about a clinical investigation for a medical device
  • USA – MYnd Analytics stock rallies after FDA gives breakthrough status for company device
  • Europe – Are You Really Ready For MDR?
  • USA – FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert
  • USA – FDA rolls out plan to reduce third party 510(k) re-reviews
  • USA – Appropriate Use of Consensus Standards: FDA Issues Draft and Final Guidance
  • USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps
  • USA – Device Firms to Prep for Electronic Submission Shift Under FDA Proposed Rule
  • USA – FDA Looks to Make FOIA Process Easier
  • USA – FDA to bolster cybersecurity of medical devices
  • Canada – Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers
  • USA – US FDA Rolls Out Pilot for Simplified 510(k) Submissions
  • Canada – Health Canada to Amend List of Recognized Standards for Medical Devices
  • Study – Modernizing the Medtech Supply Chain
  • USA – Microfluidic Device Corrals Viable Sperm for IVF
  • Canada – Veta Smart Case for Epinephrine Auto Injectors Now Available
  • USA – Masimo’s Tiny Breathing Sensor Cleared for Tiny Patients in U.S.
  • Europe – New Device Vibrates Skull to Diagnose Cause of Dizziness
  • USA – CDRH Works With IMDRF to Establish a Medical Device Single Review Program
  • USA – FDA Clarifies Policies on Acceptable Levels of Uncertainty for Devices
  • UK – Versius Robotic Surgical System Unveiled by UK Company
  • USA – Two New Penumbra Catheters to Suck Out Stroke-Causing Clots
  • USA – Theranos is Reportedly Shutting Down for Good
  • USA – A Few Things SaMD Developers Should Know
  • Europe – Electronic implant offers hope for preventing epileptic seizures
  • Europe – Europe Update: Notified Body MDD, AIMDD Timelines
  • USA – Researchers Call on FDA to Tighten Requirements for Breakthrough Devices
  • Europe – Taking a Deeper Look at Device Certification and Recertification
  • USA – ISO Preps for FDA’s Proposed Overhaul of Device Quality System Regulation
  • Discovery – Eye Test to Detect Alzheimer’s Disease Before Symptoms Start
  • USA – Updated: FDA Warns Zimmer Biomet’s Indiana Plant
  • USA – 6 Questions to Ask Yourself about ISO 11607 Compliance
  • USA – FDA plans to use ISO 13485 for medical devices regulation
  • Discovery – FlexDex Intuitive Laparoscopic Instruments Going on Sale in U.S.
  • USA – Medical Device Validation: What You Need to Know and Why It’s Important
  • USA – New Hip Replacement Procedure Launches
  • Discovery – Vagus Nerve Stimulation Highly Effective at Treating Drug Resistant Depression
  • USA – A Temporary Fix for the EpiPen Crisis?
  • Canada – Health Canada to Adopt IMDRF Table of Contents Format
  • Australia – Expands Range of Acceptable Foreign Regulators for Device Applications
  • USA – FDA Medical Device Safety Action Plan: Good or Bad for Medtech?
  • Discovery – VistaTablet for Monitoring Patients’ Eight Vital Signs from Anywhere
  • Discovery – Building a Better Insulin Infusion System
  • Dispositifs Médicaux – AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan
  • USA – FDA Issues Two Final Guidances on Communications Not Included In Product Labeling
  • USA – FDA Approves First Generic Versions of EpiPen
  • USA – FDA Approves First Contraceptive Mobile App
  • Australia – TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance
  • USA – FDA Targets Unapproved Vaginal Rejuvenation Devices
  • USA – AngioDynamics to Pay $12.5M to Settle Allegations Over Two Unapproved Devices
  • Découverte – Recherches bibliographiques pour l’évaluation de la performance clinique
  • Catégorie : International
    • International – IMDRF New Guidance : Principles and Practices for Medical Device Cybersecurity
    • International – 3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks
    • International – DM connectés : de l’aptitude à l’utilisation à l’expérience utilisateur
    • International – Patent Considerations for Connected Medical Devices
    • Saudi Arabia – Saudi Arabia medical device market update: MDMA fee increases, new regulations in the works
    • International – Cybersecurity becomes critical for hospitals buying devices
    • International – The convergence of medical device cybersecurity requirements in Australia, Canada and the USA
    • International – Disinfecting Devices at the Point-of-Care
    • International – IMDRF Opens Consultation on Annex Related to Adverse Event Terminology
    • International – What Could Blockchain Technologies Mean for the Medical Device Industry?
    • International – Implementing the IEC 60601-1 Medical Electrical Equipment Standard
    • International – WHO’s five-year plan to help build effective and efficient regulatory systems
    • International – Human factors studies: Considerations for recruiting rare and complex user populations
    • International – WHO Updates Lists of Essential Medicines, Diagnostics
    • International – IMDRF Releases New and Revised Documents Following March Meeting
    • International – 3 Critical Considerations for Evaluating Off-the-Shelf Software for Medical Devices
    • International – Medtech Salary Survey 2018
    • International – Regulatory Recap: Global Trends June 2019
    • International – Regulatory Recap: Global Trends June 2019
    • International – WHO Outlines Process to Designate Regulators as WHO-Listed Authorities
    • International – Regulating Software as a Medical Device in the age of Artificial Intelligence
    • International – 10 of the Most Influential Companies in the Cardiovascular Space
    • International – Taux de croissance de la production du marché des dispositifs médicaux connectés 2019-2025
    • Saudi Arabia – Saudi FDA regulatory update: MDR, UDI and Brexit
    • International – GHTF final documents (updated)
    • International – IMDRF Documents (updated)
    • International – WHO Guideline: recommendations on digital interventions for health system strengthening
    • International – Calculating Sample Sizes For Human Factors Studies: What’s The Magic Number?
    • International – WHO Drafts Global Strategy on Digital Health
    • International – Top 5 issues for medical device risk management and design controls
    • France – Trois fabricants partagent leur expérience de la mise en conformité à l’UDI
    • International – Is your software a medical device?
    • Brazil – Brazil’s ANVISA launching Notification pathway for low-risk medical devices and IVDs
    • International – Transition to ISO 13485:2016 Comes to an End
    • International – A Look at the Competitive Landscape of Diabetes Devices
    • India – Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices
    • International – WHO Advances International Harmonized Nomenclature for Medical Devices
    • International – Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?
    • International – Human Factors Engineering and Usability: What you should know about diary studies
    • Israel – New Israeli fund to support medical device development
    • International – CE Mark suspended for Endologix Nellix stent graft
    • International – REACH FAQs for Medical Device Professionals
    • International – IMDRF Gains Ground with Plans for a Medical Device Single Review Program
    • Ireland – Ireland’s research center for medtech eyes animal testing facility
    • India – Roche Diagnostics launches cervical cancer screening lab in India
    • International – Beta Bionics Wins Readers’ Choice for Medtech Company of the Year
    • International – Injecting quality into software development with industry-specific guidance on ISO 9001
    • India – India Adds Four Medical Device Types to CDSCO List of Regulated Products
    • India – India still lacks comprehensive regulations for medical devices
    • International – Could AI Become the New Quality Control Manager in Medical Device Manufacturing?
    • International – No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security
    • International – REACH FAQs for Medical Device Professionals
    • International – Emergo by UL Regulatory Recap: Global Trends November 2018
    • International – ISO 14155 Third Edition Preview: Role of Risk Management in Clinical Investigations
    • International – Investigative Report Casts a Troubling Light on the Medical Device Industry
    • International – Cybersécurité : un sujet à prendre au sérieux pour les dispositifs médicaux
    • International – 5 award-winning medical device innovations for unmet needs
    • International – Livre blanc sur les rapports d’évaluation clinique dans l’industrie des DM
    • International – Les points clés pour faire de l’IoT une opportunité dans le domaine du DM
    • International – Industrie medtech : léger fléchissement de l’indice LIMEDex
    • International – IMDRF Finalizes Work on Standards for Regulatory Use, Essential Principles, Personalized Devices
    • International – MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016
    • International – Global spinal fusion devices market poised for growth
    • International – Surgical Robotics Market Due for a Shake Up?
    • International – ISO 13485 : ISO board seeks feedback on quality systems standard
    • Saudi Arabia – Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions
    • International – FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK
    • Brazil – Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions
    • International – Insights on Upcoming Revisions to ISO 13485
    • International – 5 Innovative Trends of the Future in Healthcare and Medical Device Manufacturing
    • International – ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations
    • India – India Medical Device and IVD Regulatory Update: September 2018
    • International – With new blood test, Roche dives deeper into personal cancer care
    • Australia – Australia Unveils Strategy for Engaging With Foreign Regulators
    • Brazil – Brazil’s ANVISA Readies Regulations for Custom-made Medical Devices
    • Australia – Australian TGA to Accept Medical Device Approvals from Additional Overseas Regulators
    • International – Device Makers Combating Cyber Risks to Patient Health
    • International – Alcon Pulls CyPass Micro-Stent from Market Based on Long-Term Safety
    • International – Immersive Technologies in Medical Device Development: Today and Tomorrow
    • International – Boston Scientific Speaks Out About Pelvic Mesh Controversy
  • Catégorie : France
    • France – Cœur Artificiel : Carmat lève 60 M€ pour passer au Stade Industriel
    • France – Identification individuelle pour une inscription en ligne générique des dispositifs médicaux
    • France – ANSM : L’ANSM lance une consultation publique sur un projet de recommandations pour la cybersécurité des dispositifs médicaux – Point d’information
    • France – HAS : Toutes nos publications par thèmes – Recommandations, médicaments, actes, dispositifs, …
    • France – L’évaluation médico-économique des DM : état des lieux et enjeux
    • France – Application du règlement européen relatif aux dispositifs médicaux : l’ANSM met en place une phase pilote pour la partie investigations cliniques – Point d’information
    • France – Téléimagerie : guide de bonnes pratiques
    • France – Des semelles connectées pour prédire le risque de chute chez des personnes âgées ostéoporotiques
    • France – Industries de la santé et transformation numérique
    • France – Départ et nominations
    • France – Modalités de dépôt d’un dossier de demande d’évaluation d’acte professionnel
    • France – HAS : Journée d’information des fabricants de dispositifs médicaux – 29 mai 2019
    • France – France Bans Textured Breast Implants
    • France – L’ANSM décide, de retirer du marché des implants mammaires macrotexturés et des implants mammaires à surface recouverte de polyuréthane, par mesure de précaution
    • France – AFNOR : Projet de norme – Gestion du rapport bénéfice/risque PR XP S99-223
    • France – ASSEMBLEE NATIONALE : Rapport d’information sur les DM
    • France – Prévention des risques d’infection associés à l’utilisation des sondes d’échographie endocavitaire
    • France – ANSM – Prolapsus pelviens et de l’incontinence urinaire : Point d’étape sur les actions de contrôle et surveillance en cours
    • France – Modalités pratiques de dépôt d’un dossier auprès de la CNEDiMTS
    • France – Évaluer les dispositifs médicaux connectés, y compris ceux faisant appel à l’intelligence artificielle
    • France – Spécificités méthodologiques d’évaluation clinique des Dispositifs Médicaux Connectés
    • France – Un projet basé sur l’IoT pour la prise en charge des patients à domicile
    • France – Dispositifs médicaux : garantir leur sécurité et leur efficacité
    • France – Un guide sur l’aptitude à l’utilisation des DM co-signé Cetim et Snitem
    • France – Signature du Contrat stratégique de la filière « Industries et Technologies de Santé »
    • France – Nouveau livret du SNITEM : la Personne chargée de veiller au respect de la réglementation
    • France – Nouveau livret du SNITEM : le Fabricant
    • France – Dispositifs médicaux : garantir leur sécurité et leur efficacité
    • France – Prothèses capillaires et accessoires (HAS)
    • France – Plus de marquage CE pour les implants mammaires texturés d’Allergan
    • France – Face à une situation de plus en plus critique, la France lance un appel à candidatures d’organismes notifiés
    • France – Grande Enquête Nationale sur les Dispositifs Médicaux et sur l’application du Règlement UE 2017/745 (RDM)
    • France – L’enquête internationale « Implant Files » montre les « incroyables lacunes de la surveillance en France »
    • France – Préservatif remboursé : la Sécu aurait-elle les bourses trop pleines ?
    • France – Implants: ce que les nouvelles règles vont changer
    • France – Premier préservatif remboursé par l’Assurance maladie
    • France – Affaire Implant Files: le SNITEM communique
    • France – Les dispositifs médicaux sont « une zone d’ombre et d’inquiétude », selon Agnès Buzyn
    • France – « Cash Investigation » : le scandale sanitaire des prothèses vaginales
    • France – Implants médicaux : le manque de contrôle dénoncé par un consortium de journalistes
    • France – Cancers : « La balance bénéfice/risque est toujours favorable aux implants mammaires pour les femmes », rassure Agnès Buzyn
    • France – Il est désormais possible d’imprimer des implants en PEEK
    • France – Les objets connectés de santé : attention aux fausses promesses !
    • France – Reste à Charge 0 ou 100 % santé : le projet de décret dévoilé
    • Snitem – Application de diagnostic personnalisé pour le nouveau règlement européen
    • France – Éval. techno santé : place de la qualité de vie
    • France – Loi n° 2018-892 du 17 octobre 2018 relative à la désignation aléatoire des comités de protection des personnes
    • France – La HAS accorde le Forfait Innovation au système WISE CRT, dispositif médical implantable de resynchronisation cardiaque
    • France – Une nouvelle norme (ISO 14607) pour les implants mammaires
    • France – Prothèses PIP : la Cour de cassation ordonne un nouveau procès pour le certificateur TÜV
    • France – Cœur artificiel : la société Carmat ouvre sa première usine et vise une production de 500 prothèses par an
    • France – Jugées dangereuses, 50% des machines pour le don de plasma ont été retirées en France
    • France – HAS/CNEDiMTS : Contribution patients : nouvelle règle à compter du 01/08
    • France – Le LNE filialise son activité GMed de certification médicale
  • Catégorie : Europe
  • Catégorie : Amériques
    • USA – Will Medtech Rise to FDA’s Sterilization Challenge?
    • USA – US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes
    • USA – FDA Updates 1989 Policies on Diagnostic X-Rays as Electronic Products
  • Catégorie : Asie-Pacifique
  • Catégorie : Découverte
    • USA – How a Brain-Computer Interface Could Help Paralyzed Veterans at Home
• Catégorie : Cosmétiques
  • Catégorie : France
    • France – La FEBEA Révèle Deux Etudes Inédites sur l’Impact Socio-Economique et sur l’Attractivité de la Cosmétique Française
    • France – L’Anses recommande de restreindre les substances persulfates dans les produits capillaires
    • France – La France domine le marché mondial de la beauté mais doit s’adapter
    • France – Les produits cosmétiques non rincés contenant du phénoxyéthanol ne doivent pas être utilisés sur les fesses des enfants de 3 ans ou moins – Point d’Information
    • France – Programme d’évaluation de la conformité des sites aux BPL de l’ANSM (médicaments à usage humain, produits cosmétiques et produits de tatouage) : mise à jour de la liste
    • France – Formations Cosmétiques 2019
    • France – FORMATION : Réglementation Européenne des Produits Biocides
    • France – FORMATION EN LIGNE : Microbiologie des Produits Cosmétiques 
    • France – Livre Blanc « Que Contient Mon Produit Cosmétique ? »
    • France – New app to help consumers avoid ‘undesirable or allergenic’ cosmetics ingredients
    • France- Bronzage en institut : Les précautions d’usage de la DGCCRF
    • France – Applications cosmétiques : La FEBEA pointe les insuffisances scientifiques
    • France – INSTITUT SCIENTIS : Formations et Wébinaires 2019
    • Europe – Projet de règlement Phenylene Bis-Diphenyltriazine
    • France – Publicité & Langue Française
    • France – Lumière bleue : L’industrie cosmétique cherche à consolider les bases scientifiques de ses revendications
    • France – Applications cosmétiques: les industriels veulent plus de « rigueur scientifique »
    • France – Nanoparticules : Quel est le sens de la plainte de l’UFC-Que Choisir ?
    • France – WEBINAIRE Décryptage du microbiome : applications cosmétiques et biocides Mercredi 26-sept – 10h-11h
    • France – Mise à jour : La liste des installations d’essai du programme d’évaluation de la conformité aux BPL de l’ANSM
    • France – Mise sur le Marché Européen des Produits Cosmétiques-Généralités
    • France – Les Français sceptiques quant à l’efficacité des compléments alimentaires beauté
    • France – Silab met en évidence les modifications du microbiote des peaux caucasiennes âgées
    • France – Le CED fait sa rentrée sur le vieillissement cutané
    • France – La France va inventorier les substances nuisibles aux récifs coralliens
  • Catégorie : Europe
    • Europe – Cannabidol beauty in the EU: It’s ‘reasonably predictable’ inspections will increase
    • Europe – Hemp oil vs. CBD for anti-inflammatory skin care: Study
    • UK – BREXIT – ‘No Deal’ Contingency Planning
    • Europe – Opinion On Allergy Alert Test (AAT) as a proof-of-concept study
    • Europe – ‘Free from’ guidance should create level playing field in EU
    • Europe – CBD skin care: EU study shows antioxidant promise for topical disease treatment
    • Europe – EU ‘free from’ cosmetics claims technical document is guidance, not regulation
    • Europe – In the face of Brexit? Harmonising EU cosmetics compliance remains the goal, says regulatory expert
    • Europe – Information on Cosmetic Packaging Materials in the Context of the EU Cosmetics Regulation EC 1223/2009 (Recommandations pour l’évaluation des emballages cosmétiques)
    • Europe – How genetic insights can personalise skin microbiome launches
    • Europe – SCCS – Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)
    • Europe – Règlement (UE) 2017/1410 de la Commission
    • Europe – CBD and cosmetics in Austria: What is the legislative environment?
    • Europe – How the New Free From Claims Impact the European Cosmetics Space
    • Europe – Regulation change: the end of ‘free from’ claims for beauty and personal care?
    • Europe – Le Règlement UE 2019/831 dit « Omnibus » est enfin publié !
    • Europe – Allergies cutanées : restreindre les substances chimiques dans les textiles, cuirs, fourrures et peaux
    • Europe – Protecting formulas: Making more with less
    • Europe – Notification aux centres antipoison : ouverture du portail de déclaration des mélanges dangereux
    • Europe – Publication du Glossaire des ingrédients : la version actualisée de Verif INCI est disponible
    • Europe – Produits de blanchiment dentaire, l’EDQM signale des problèmes de non-conformité
    • Europe – EU highlights concerns with Israel’s draft cosmetics regulation
    • Europe – 5 top regulation and safety updates to know about
    • Europe – SCCS – Final version of the Addendum to the scientific Opinion SCCS/1491/12 on the hair dye substance 2-Methoxy-methyl-p-phenylenediamine and its sulfate salt – COLIPA n° A160 – Submission II (use on eyelashes)
    • Europe – SEAC concludes to restrict hazardous substances in tattoo inks
    • Europe – Protecting consumers against endocrine disruptors – the BEUC letter
    • Europe – 5 latest updates for regulation and safety in beauty: 2019
    • Europe – No-deal Brexit : À quoi doit se préparer l’industrie des cosmétiques ?
    • Europe – Nouveau glossaire des dénominations communes des ingrédients (INCI) (Projet de texte établi conformément au règlement cosmétique 1223/2009)
    • Europe – Opinion SCCS/1491/12 on eyelashes
    • UK – Emollient cream build-up in fabric can lead to fire deaths
    • Europe – Public consultation launched on restricting substances in tattoo inks
    • Europe – Règlement Européen sur les produits cosmétiques
    • Europe – Rapport sur les Perturbateurs Endocriniens
    • Europe – « Produits Cosmétiques » : mise à jour de l’ARPP
    • Europe – EU publishes strategy on hormone disrupting chemicals
    • Europe – 10ème révision du document « THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION »
    • Europe – The Impact of a ‘No deal’ Brexit on the Cosmetics Industry
    • Europe – Is vegan testing the latest step towards cruelty-free beauty?
    • Europe – Cosmetics Business Regulatory Summit Day 1: From safety assessment to Brexit
    • Europe – EU Scientific Committee publishes opinion on salicylic acid safety in cosmetics
    • Europe – Dernière lettre d’information émise par le Service national d’assistance REACH-CLP
    • Europe – The draft Commission Regulation aims at prohibiting the use of the substance 2-Chloro-p-Phenylenediamine
    • Europe – SCCS : Opinion finale sur le modèle d’évaluation quantitative du risque de la sensibilisation cutanée due à un ingrédient de parfum (QRA 2)
    • Europe – SCCS : opinion relative à la sécuritésubstance Phenylene Bis-Diphenyltriazine
    • Europe – Le programme de stratégie scientifique à long terme de Cosmetics Europe
    • Europe – Nouvelle version Consolidée du règlement cosmétique (CE) n°1223/2009 publiée le 01.08.2018
    • UK – En Grande-Bretagne, les soins du visage plébiscités par les consommatrices
  • Catégorie : International
    • Asia – ‘Time for cosmethics’: Why ISO standards are crucial for organic and natural transparency – CFTAS president
    • USA – Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination
    • USA – Voluntary Cosmetic Registration Program Report for September 2019.
    • USA – What’s going on with CBD legislation for beauty?
    • Canada – How to register your cosmetic products in Canada
    • Jamaica – Jamaican authorities eye expansion into medical cannabis
    • USA – VCRP Monthly Status Report : August 2019.
    • Asia – Laws and regulation: Top news on cosmetics regulation across the APAC region
    • Thailand – Cash crop: Thai authorities approve use of hemp in food, cosmetics and CBD in herbal products
    • Australia – Australian regulatory guidelines for sunscreens (ARGS)
    • Taiwan – The Cosmetic Hygiene And Safety Act Reshaped Taiwan’s Cosmetic Regulation
    • Asia – Asbestos-containing cosmetics: Officials reveal products were manufactured in China, not Taiwan
    • Asia – Laws & Regulation: Top news on cosmetics regulation across the APAC region
    • Singapore – HSA Alert: Undeclared Potent Ingredients Found in Four Skin Creams; Infant Hospitalised with Serious Adverse Reaction
    • USA – Voluntary Cosmetic Registration Program Report for June 2019
    • International – Everything you always wanted to know about in vitro toxicology for cosmetics
    • International – CTPA : “Guideline on Artificially Enhanced Nails and Minimising the Risk of Allergy”
    • Australia – Inconsistent policies: Aussie researchers call for more harmonised sunscreen guidelines
    • USA – CBD product makers should be mindful of FDA guidelines
    • Asia – Changes, challenges and opportunities: ACA President on sustainability and regulation in APAC
    • USA – Cosmetics Recalls & Alerts
    • International – Ingredients players come up with smart solutions to CBD regulation.
    • China – Chinese cosmetics regulation and key differences with the EU
    • International – Examine all available evidence before making decisions on sunscreen ingredient bans.
    • USA – Should we be worried that the chemicals from sunscreen can get into our blood?
    • China – Chinese cosmetics regulation: how does it work?
    • USA – VCRP Monthly Status Report
    • USA – Tracking the sunscreen crackdown
    • International – The impact of airborne pollution on skin
    • USA – FDA issues final rule on safety and effectiveness of consumer hand sanitizers
    • China – Animal testing ban still ‘unlikely’ even as China greenlights alternative processes for cosmetic ingredients
    • USA – Time for a makeover-cosmetics regulation in the United States.
    • USA – VCRP Monthly Status Report
    • International – Le logiciel de l’INRS répondant aux besoins des utilisateurs de produits chimiques dans leur démarche de prévention du risque cutané
    • International – Assessment of targeted non-intentionally added substances in cosmetics in contact with plastic packagings. Analytical and toxicological aspects
    • International – Laws & Regulation: Top news on cosmetics regulation across the APAC region
    • USA – Voluntary Cosmetic Registration Program Report for February 2019
    • International – Les changements réglementaires à l’international
    • International – Validation of an in vitro sun protection factor (SPF) method in blinded ring‐testing
    • USA – FDA advances new proposed regulation to make sure that sunscreens are safe and effective
    • Korea – Korea Requires Infant and Children Cosmetic Responsible Sales Managers to Establish Product Safety Data
    • International – ‘Morning routine’: Sunscreen guidance revamped by safety bodies in Australia and New Zealand
    • Vietnam – A Comprehensive Guide to Cosmetics Registration in Vietnam
    • International – The future of in silico chemical safety … and beyond
    • International – Réduction des coûts dans la gestion des produits chimiques
    • International – Sun protection ‘oversimplification’? Researchers question current WHO guidelines
    • International – Publication de la norme ISO 11930:2019 sur l’évaluation de la protection antimicrobienne d’un produit cosmétique
    • China – Liste des ingrédients en Chine
    • Philippines – Mercury in cosmetics: Philippine city introduces new rules to protect public
    • Singapore – Skin-on-a-Chip: Singaporean scientists develop device which can replace animal-testing
    • China – Exporting cosmetics to China just got a bit easier
    • China – China officially replaces imported cosmetic registration with nationwide filing management
    • International – L’Oréal Releases Sun Exposure Monitor Through Apple
    • Asia – Laws & Regulation: Top news on cosmetics regulation across the APAC region
    • USA – FDA Requests Comments on New Consumer Survey about Allergens in Cosmetics
    • USA – FDA takes action to stop the use of lead acetate in hair dyes
    • International – Extrapolation of in vitro structural alerts for mutagenicity to the in vivo endpoint
    • International – Nouveau code de conduite pour l’industrie mondiale du marketing et de la publicité
    • USA – VCRP Monthly Status Report
    • International – Cosmétiques naturels et bios : La nouvelle norme ISO fait débat
    • Brésil – L’ANVISA s’engage à simplifier la réglementation des cosmétiques pour enfants
    • USA – VCRP Monthly Status Report
    • International – Fragrance Material Safety Assessments
    • USA – The Allergy Alert Test: Introduction of a Protocol Suitable to Provide an Alert Signal in p-Phenylenediamine–Allergic Hair Dye Users
    • International – Gesturecare. Modeler votre beauté naturelle.
    • International – What happened this summer?
    • International – L’Afrique est-elle l’Asie du futur ?
    • Study – Chemical stability and in chemico reactivity of 24 fragrance ingredients of concern for skin sensitization risk assessment
    • Study – A multi-detector chromatographic approach for characterization and quantitation of botanical constituents to enable in silico safety assessments
    • Afrique – L’Afrique, de plus en plus accro aux produits de blanchiment de la peau
    • International – La Turquie impose des droits de douane de 60% sur les cosmétiques américains
    • International – L’Oréal veut booster ses ventes sur Facebook avec des tests de maquillage en réalité augmentée
    • Chine – Les cosmétiques séduisent la clientèle masculine
    • Brésil – Beraca veut faciliter l’accès aux ingrédients issus de la biodiversité brésilienne
    • International – Ingrédients synthétiques de parfumerie – Un juste retour de flamme
• Catégorie : Santé Publique
  • France – La T2A a redirigé des séjours chirurgicaux des cliniques privées vers les hôpitaux publics sans augmenter l’activité totale
  • France – Découvertes de séropositivité VIH et diagnostics de sida en France en 2018
  • France – La bonne affaire de la hausse des prix du tabac
  • France – Obésité : Agnès Buzyn présente sa feuille de route nationale
  • France – L’espérance de vie en bonne santé à 65 ans continue à progresser en France
  • France – Pilotage de la dépense de santé : redonner du sens à l’Ondam
  • France – Les chiffres clés 2018 de la sécurité sociale (édition 2019)
  • France – Le projet de budget 2020 de la Sécurité sociale présenté en conseil des ministres du 9 octobre 2019
  • France – Sécurité sociale 2019. La Cour des comptes publie son rapport annuel sur l’application des lois de financement de la sécurité sociale
  • International – Johnson & Johnson condamné à payer 8 G$ US pour un médicament controversé
  • France – L’homéopathie ne sera plus remboursée dès 2021
  • France – Médicaments dangereux, implants défectueux… Ces autres scandales sanitaires que le Mediator survenus en France ces dernières années
  • France – Loi de bioéthique. L’Assemblée abandonne la technique du « bébé médicament »
  • France – Une étude du CREDOC analyse les populations éligibles à la CMU-C et à l’ACS
  • France – Le pictogramme « grossesse » trop souvent utilisé sur les médicaments
  • France – Fraude à la sécurité sociale : 261,2 millions d’euros détectés en 2018
  • France – Projet de loi de financement de la Sécurité sociale 2020 – PLFSS 2020
  • UK – NICE guidance could avert 1,000 neonatal admissions
  • France – Communiqué de presse – Agnès BUZYN – Accès IVG
  • UK – Declining childhood vaccination rates ring alarm bells in England
  • UK – NICE backs womb op for babies with spina bifida
  • France – Discours Agnès BUZYN – Bioéthique 24 septembre 2019
  • France – Pénurie de médicaments: le gouvernement met la pression sur les labos
  • France – Pénurie de médicaments : un quart des Français concernés
  • USA – U.S. CDC expects hundreds more cases of vaping-related illness
  • France – E-cigarette : la France va surveiller les maladies liées au vapotage
  • China – China may roll out e-cigarette rules amid global vaping backlash: state media
  • USA – What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
  • International – Crise du vapotage: Sept morts et 500 malades aux Etats-Unis, la France ouvre l’oeil
  • France – Fiscalité du médicament : L’écart se creuse entre la France et ses concurrents européens
  • France – Révision des lois de Bioéthique
  • France – Premier anniversaire du remboursement de la téléconsultation : plus de 60 000 actes auront été facturés au 15 septembre 2019
  • France – Urgences hospitalières : Agnès Buzyn dévoile un plan doté de plus de 750 millions d’euros de crédits jusqu’en 2022 pour mettre fin à la crise
  • France – Dépenses de santé : le reste à charge des Français est tombé à son plus bas historique en 2018
  • France – 7 millions d’assurés disposent d’un DMP en septembre 2019. Les médecins s’impliquent de plus en plus
  • France – Les enseignes de grande distribution se lancent sur le marché des lunettes
  • France – La surprenante requête de Servier pour récupérer des indemnités versées aux victimes du Mediator
  • Europe – Vaccination : des contre-indications qui n’en sont pas
  • International – L’épidémie chinoise de grippe porcine menace l’héparine, un médicament universel
  • France – Perturbateurs endocriniens : le Gouvernement présente une deuxième stratégie nationale afin de réduire l’exposition de la population et la contamination de l’environnement
  • Europe – Préparation à un retrait sans accord: la Commission demande une dernière fois à toutes les entreprises et à tous les citoyens de l’UE de se préparer au retrait du Royaume-Uni le 31 octobre 2019.
  • International – WHO Launches Registry for Gene Editing Studies
  • UK – E-cigarettes: regulations for consumer products
  • France – Une étude confirme l’absence de lien entre vaccins et sclérose en plaques
  • France – En 2017, 18 % des adolescents en classe de troisième sont en surcharge pondérale et 5 % sont obèses
  • Canada – Un drone livre avec succès des médicaments sous ordonnance
  • Europe – L’Organisation mondiale de la santé alerte sur le retour de la rougeole en Europe
  • Spain – un médicament mal étiqueté provoque le « syndrome du loup-garou » chez des enfants
  • International – Possible link between C-section and autism, ADHD
  • France – Levothyrox : polémique autour de la bioéquivalence de la nouvelle formule
  • International – Une multi-pilule pour réduire le risque d’accidents cardiovasculaires
  • UK – New cancer research could help boost immunotherapy treatments
  • France – Une nouvelle étude confirme le fort taux de médication des femmes enceintes en France
  • France – Gestion des vigilances sanitaires : publication du référentiel pour les traitements de données personnelles
  • France – LOI no 2019-774 du 24 juillet 2019 relative à l’organisation et à la transformation du système de santé (1)
  • France – La CNIL publie un nouveau modèle de registre simplifié
  • UK – Skin cancer rates rocket 45% in 10 years
  • France – Santé : le lait hypoallergénique pour bébé ne diminue pas le risque d’allergie
  • UK – First UK medical cannabis clinic launched by specialist doctors
  • France – Médiator : le ministère craindrait la condamnation de l’ANSM
  • UK – NICE to review its decision making processes
  • USA – FDA launches its first youth e-cigarette prevention TV ads
  • International – Une nouvelle fiche repères sur les perturbateurs endocriniens
  • France – La HAS lance son nouveau site internet
  • France – Le cap des 6,4 millions de dossiers médicaux partagés (DMP) ouverts est franchi annonce la CNAM
  • France – HAS : Dépistage du cancer du col de l’utérus : le test HPV recommandé chez les femmes de plus de 30 ans
  • USA – Tighter e-cigarette laws may up tobacco use in young adults
  • USA – Maladie de Lyme : une expérimentation secrète du Pentagone qui aurait dérapé ?
  • France – Les homosexuels pourront donner leur sang après quatre mois d’abstinence sexuelle
  • France – Homéopathie : Emmanuel Macron donne son feu vert à un déremboursement total au 1er janvier 2021
  • France – La France a la plus forte fécondité d’Europe. Est-ce dû aux immigrées ?
  • France – ATMS : Agénésies transverses des membres supérieurs : rapport du comité d’experts scientifiques
  • France – ANSM : l’ANSM, a donné son feu vert pour tester le cannabis thérapeutique en France
  • France – L’Assemblée nationale donne son ultime feu vert au projet de loi santé
  • UK – NHS health information available through Amazon’s Alexa
  • UK – Early cancer detection and survival to be prioritised by NHS
  • France – Plan national Santé-Environnement 4 (PNSE 4), « Mon environnement, ma santé » (2020-2024)
  • UK – Malaria cases remain at highest level since 2011
  • France – Pénuries des médicaments : Communique de Presse d’Agnès BUZYN
  • France – Déremboursement de l’homéopathie : Emmanuel Macron a donné son feu vert
  • France – Estimations nationales de l’incidence et de la mortalité par cancer en France métropolitaine entre 1990 et 2018. Nouveau rapport de Santé publique France
  • France – Les établissements de santé – édition 2019
  • International – UNODC reports drug dependence increasing globally
  • USA – US states find it hard to regulate abortion pills sold online
  • France – « Industrie du Futur : enjeux et perspectives pour la filière industries et technologies de santé »
  • France – 700 000 Français auraient arrêté de fumer grâce à la cigarette électronique
  • France – Agnès Buzyn inquiète de la montée en charge relativement lente des actes de télémédecine
  • France – Le TROD de l’angine à streptocoque bientôt réalisé en pharmacie sans prescription médicale
  • International – À quel prix le Zolgensma®, le médicament le plus cher du monde, sera-t-il vendu en France?
  • France – Un avis sans concession de la HAS contre le remboursement de l’homéopathie
  • France – Canicule et produits de santé
  • UK – Government pledges to fight ‘deadly’ antimicrobial resistance
  • France – Numérique : quelle (r)évolution ? – Rapport d’analyse prospective 2019 de la HAS
  • France – La HAS publie ses premières recos sur les téléconsultations
  • France – Urgences médicales : une affaire avant tout institutionnelle !
  • Europe – Une nouvelle Revue Cochrane examine les données relatives à différents moyens de réduire la consommation de boissons sucrées
  • France – Cannabis à visée thérapeutique en France : Projet de cadre de la phase expérimentale de mise à disposition – Point d’Information
  • France – 29 propositions pour que le numérique en santé remplisse ses promesses
  • France – Cannabis «thérapeutique»: une appellation «abusive», selon l’Académie de pharmacie
  • France – Réforme du 100% santé avec les représentants de l’assurance maladie, des organismes complémentaires et des assurés
  • International – Severe Acute Malnutrition (SAM): The Value of a Ready to use Therapeutic Food (RUTF) Guideline
  • UK – Modified vaccinia virus shows potential in fighting sarcoma tumours
  • France – On peut mettre fin au scandale des urgences à l’hôpital
  • France – Téléconsultations sur plateformes nationales : le Conseil d’Etat refuse le remboursement par l’Assurance maladie
  • France – « Cartographie médicalisée des dépenses de santé » sur les pathologies à la fois fréquentes et graves et les dépenses associées
  • France – Le déficit de la Sécurité sociale « se creuserait » de nouveau en 2019, entre 1,7 et 4,4 milliards d’euros, annonce la Commission des comptes
  • USA – FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems
  • France – La satisfaction des Français à l’égard du système de santé s’améliore, selon le baromètre Deloitte « Les Français et la santé »
  • France – Expérimentation du remboursement des psychothérapies dans 4 CPAM. La CNAM resserre les boulons
  • India – Indian diplomat: India provides world 2/3 of AIDS drugs
  • USA – FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks
  • USA – Could Myriad’s New Study Results Be Game Changers For Cancer Patients?
  • France – Ouverture du processus électoral pour la présidence du Leem et entrée de 5 nouveaux administrateurs au CA
  • International – Cancer : des nanoparticules d’or pourraient détruire les tumeurs
  • International – Lutte contre le cancer : «Les nanoparticules ne sont pas toutes mauvaises»
  • France – Maintenir les hôpitaux, mais à quelles conditions ?
  • France – 1,6 million de fumeurs en moins en deux ans, annonce Santé publique France. Une baisse d’ampleur inédite
  • UK – NHS to launch new online type II diabetes support
  • France – CAR-T cells : des médicaments prometteurs, que la HAS réévaluera pour en confirmer le potentiel
  • USA – L’administration américaine autorise un médicament à 2 millions de dollars
  • France – Le prix Innov’GDR remporté par Antithromboclic de la DRSM Île-de-France et la DCGDR
  • France – La moitié des cliniques privées feraient des factures abusives
  • France – Accès simplifié au traitement contre l’hépatite C chronique à l’ensemble des médecins, notamment les généralistes
  • The Best Colon Cancer Screening Test Is the One That Gets Done
  • International – Prix des médicaments : des ONG appellent à une plus grande transparence
  • Germany – New Alzheimer’s drug shows promise in early-stage human trials
  • International – WHO: More countries adopting plans to reduce hepatitis C rates
  • International – Advance Discovery Science for Public Health Impact
  • Europe – L’accord entre les membres du G7 renforce leurs engagements en faveur d’un accès à la santé pour tous.
  • Europe – Des médicaments contre la toux bientôt interdits en raison d’un risque pour le coeur
  • France – Santé : le mirage du paiement à la performance
  • France – Doctolib : un géant de la santé qui commence à inquiéter
  • France – L’e-prescription de médicaments expérimentée d’ici l’été 2019 dans 3 départements
  • France – DMP : 8 Français sur 10 en ont déjà entendu parler mais seulement 13 % l’ont ouvert
  • France – La HAS rappelle le calendrier de son évaluation des médicaments homéopathiques
  • USA – Ongoing data tracking helps predict disease, personalize medicine
  • France – A redécouvrir : Fil Santé #
  • France – Cancer colorectal – marché annulé : l’Assurance maladie prend une « mesure d’urgence » pour assurer le dépistage
  • France – La France présente quelques unes de ses mesures innovantes pour lutter contre l’antibiorésistance
  • France – Espérance de vie : une évolution en demi-teinte
  • France – Revenus 2017 des médecins : 111 161 euros pour les spécialistes, 77 243 euros pour les généralistes
  • France – Une loi pour améliorer la prise en charge des cancers pédiatriques
  • France – Une véritable harmonisation des régimes de sécurité sociale au sein de l’UE n’est pas pour demain
  • France – Agnès Buzyn présente la feuille de route sur l’accélération du virage numérique en santé
  • International – Guidelines proposed for newly defined Alzheimer’s-like brain disorder
  • International – WHO Details Plan to Combat Antimicrobial Resistance Globally
  • France – Nominations au sein de la Haute Autorité de Santé
  • China – Survival rate for breast cancer rises in China
  • France – Projet de loi santé : les députés donnent leur feu vert au développement de l’e-prescription et au télésoin
  • International – ‘Landmark’ study links air pollution to unborn baby growth
  • France – Agnès Buzyn, ministre de la Santé, annonce les 10 lauréats de l’appel à projet du Health Data Hub
  • France – Le succès du nouveau DMP se confirme avec cinq millions de dossiers ouverts
  • International – Decline in measles vaccination is causing a preventable global resurgence of the disease
  • USA – Gene therapy cures infants suffering from ‘bubble boy’ immune disease
  • France – La recherche et le traitement de Helicobacter pylori
  • France – La nouvelle plateforme DoctoChrono vous propose un rendez-vous en ligne prioritaire moyennant finances
  • France – L’autorité de la Concurrence invite à réformer la distribution des médicaments et le rôle du pharmacien
  • France – Premier classement Formindep des CHU français selon leur politique de prévention des conflits d’intérêts : des efforts rares et timides
  • France – La DREES réédite son ouvrage thématique dédié à l’assurance maladie complémentaire
  • France – Pertinence en santé : le Think Tank Economie Santé soumet de nouvelles pistes à Agnès Buzyn
  • France – Nouvel épisode judiciaire autour du marché du dépistage organisé du cancer colorectal
  • Europe – AI Used to Assess Treatment Response for Brain Tumors
  • France – Les tests d’angine en pharmacie bientôt remboursés
  • France – Les Académies de médecine et de pharmacie se prononcent contre l’homéopathie
  • UK – Brexit : médicaments et dispositifs médicaux, quel impact pour le patient ?
  • USA – FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
  • UK – AI Program Can Predict Premature Death
  • International – Effort to Regulate Chemicals in Personal Care Products Commended
  • International – Les concours aident-ils les fumeurs à cesser de fumer à moyen et à long terme ?
  • Europe – EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack
  • France – Rapport d’enquête sur la présence de dioxyde de titane dans les dentifrices
  • France – Les facteurs de risque des patients hospitalisés pour un premier épisode d’accident vasculaire cérébral en France
  • France – Ouverture d’une « clinique de consultations médicales à distance » à Nancy
  • France – Pourquoi l’espérance de vie augmente moins vite en France ?
  • France – Les députés examinent en première lecture le projet de loi relatif à l’organisation et à la transformation du système de santé
  • France – Homéopathie : la HAS détaille sa méthode d’évaluation
  • USA – US approves first treatment for post-partum depression
  • International – WHO Panel Calls for Global Gene Editing Registry
  • Europe – High blood pressure, diabetes and obesity each linked to unhealthy brains
  • France – SANTÉ 2030 : une analyse prospective de l’innovation en santé
  • France – Frédéric Bizard : « L’hôpital de proximité est le cheval de Troie pour contrôler les médecins libéraux »
  • France – Arrêté du 22 février 2019 définissant les compétences des diplômés du doctorat et inscrivant le doctorat au répertoire national de la certification professionnelle
  • Europe – Cholestérol : un nouveau médicament pourrait remplacer les statines
  • USA – NCI’s Sharpless to Serve as Acting FDA Commissioner
  • Europe – Salmonella Poona multi-country outbreak linked to infant formula
  • Europe – Produits pharmaceutiques dans l’environnement: la Commission définit des mesures pour faire face aux risques et aux défis posés
  • France – Calendrier vaccinal : édition 2019
  • International – Milestone reached as HIV remission achieved in second patient
  • France – Levothyrox : Merck salue un « jugement équilibré et tout à fait fondé » du tribunal de Lyon
  • USA – Egg oral immunotherapy may be beneficial for pediatric egg allergy
  • France – Cancer colorectal – Le dépistage des personnes à risque en 5 points
  • France – Le CNOM laxiste avec les abuseurs sexuels ?
  • France – DMP : Open bar sur vos données médicales ?
  • France – TABAC : baisse du nombre de fumeurs
  • France – Risques professionnels liés aux nanomatériaux
  • France – Simulation en santé et gestion des risques
  • France – Le VIVA Lab pour innover en faveur du Bien Vieillir est signé et lancé !
  • France – Un numéro thématique du BEH entièrement consacré aux risques sanitaires associés à la consommation d’alcool
  • UK – New cancer drug payment system could speed up treatment
  • France – Antalgiques opioïdes : l’ANSM publie un état des lieux de la consommation en France – Point d’Information
  • France – L’industrie pharmaceutique lance des pistes pour endiguer les pénuries de médicaments
  • France – Des boîtes Upfen 200 mg sont rappelées pour une erreur sur la notice
  • Europe – Salmonella cases in humans: assessing current EU reduction targets
  • France – Les médecins libéraux sont-ils des salariés de la CPAM ?
  • France – La Cour des comptes rend public un référé sur la pertinence de la prescription des antibiotiques
  • France – Agénésie transverse des membres supérieurs : point d’étape de l’Anses et Santé publique France
  • France – L’ANSM met en place l’adresse lanceur.alerte@ansm.sante.fr – Point d’Information
  • France – Hébergeur de Données de Santé (HDS), pourquoi tout le monde s’y met ?
  • France – Santé publique France lance Géodes, un observatoire cartographique dynamique permettant d’accéder aux principaux indicateurs de santé
  • Europe – European measles cases hit a ten year high
  • UK – NHS to operate lung cancer scanning trucks across UK
  • France – Levothyrox : le Parquet élargit l’enquête pénale au chef « d’homicide involontaire »
  • France – TÉLÉMÉDECINE, la vraie médecine de proximité
  • France – Avenant n° 11 à la convention pharmaceutique : la FSPF demande le déclenchement de la clause de revoyure alors que l’USPO et la CNAM annoncent une économie de l’officine stabilisée
  • France – Combien gagnent nos dirigeants publics dans la Santé ? La transparence est encore loin d’être au rendez-vous
  • France – Produits de santé : pourquoi tant d’incompréhension du public ?
  • France – Le projet de loi relatif à l’organisation et à la transformation du système de santé inclut plusieurs mesures sur la santé numérique
  • France – L’ANSM et la CNAM s’associent pour créer Epi-Phare, une structure d’expertise publique en épidémiologie des produits de santé
  • France – L’OCDE classe une fois de plus la France à la première place des pays où la dépense sociale est la plus élevée
  • UK – Antimicrobial resistance « as big a danger to humanity as climate change or warfare »
  • France – Enquête : les Français et les essais cliniques en cancérologie
  • USA – Using Sequencing and AI for Infectious Disease Detection
  • France – L’Anses recommande d’améliorer la sécurité sanitaire des couches pour bébé
  • USA – New Blood Test Determines Likelihood of Lung Transplant Rejection
  • France – Diabète & podologie – La prévention recommandée dès le grade 1
  • France – « 100 % santé ». Les audioprothésistes proposent une contractualisation collective directe avec les complémentaires santé
  • UK – UK Parliament Rejects Brexit Agreement as EFPIA Warns of Threats to Patient Safety
  • International – Drug companies create data-sharing initiative
  • France – Le succès du DMP tributaire du bon vouloir des hôpitaux
  • USA – New Study Finds Discrepancies in Cervical Cancer Screening Rates
  • UK – E-cigarettes: regulations for consumer products
  • France – Lunettes Pour Tous, le discounter qui révolutionne l’optique
  • France – Les inhibiteurs du checkpoint immunitaire, une efficacité sexiste…
  • France – Agnès Buzyn : “construire un État plus efficace, plus proche des attentes des citoyens, recentré sur ses missions principales”
  • France – Agnès Buzyn a installé le premier comité de pilotage et de suivi de la réforme du 100 % santé
  • France – Les coordonnées du DPO du promoteur ne doivent pas figurer sur les fiches d’information destinées aux personnes se prêtant à des recherches cliniques !
  • France – La nouvelle définition des recherches non interventionnelles ne respecte pas le droit européen
  • USA – 2018 Research Highlights — Promising Medical Advances
  • France – Santé publique : la France mérite beaucoup mieux !
  • France – Agnès Buzyn : J’accuse !
  • France – Éducation thérapeutique du patient (ETP) : évaluation de l’efficacité et de l’efficience dans les maladies chroniques
  • Europe – Emerging Health Threats: EMA Releases Response Plans
  • France – La HAS lance un appel à candidatures pour la création d’un Conseil pour l’engagement des usagers
  • France – 70 % des professionnels de santé ne pensent pas faire de télémédecine dans l’année à venir
  • France – La barre des 3 millions de DMP est franchie, se félicite la CNAM
  • France – Visuchir, l’application de la CNAM pour visualiser l’activité chirurgicale, notamment ambulatoire, des établissements de santé
  • France – La HAS publie les résultats 2018 de la qualité et de la sécurité des soins dans les établissements de santé français
  • France – Préparation et manipulation du Slime : les autorités sanitaires appellent à rester vigilant
  • France – La HAS affine ses indicateurs pour mesurer le résultat au bénéfice du patient
  • France – L’examen à l’œil nu ne suffit pas pour un diagnostic précis des cancers de la peau, affirment les experts
  • France – Le CNOM publie l’Atlas 2018 de la démographie médicale. Moins de généralistes, plus « d’inégalités territoriales »
  • France – Signature de l’avenant télémédecine à l’officine
  • France – PLFSS 2019 : adoption dans la tourmente
  • Europe – Hospitalisation à domicile : le ministère et la HAS mettent en place 2 dispositifs
  • International – Childhood Infections May Trigger Mental Illness
  • USA – FDA Formally Recognizes First Public Genetic Database
  • International – Measles Are Coming Back Around The World, And The Reasons Should Make Us Ashamed
  • France – L’ANSM s’engage dans l’accès plus rapide et plus sûr aux médicaments innovants pour les patients
  • France – Alerte sanitaire sur un produit utilisé pour la dialyse
  • France – Éducation thérapeutique – Patients et soignants, tous engagés !
  • France – Le DMP serait-il un mauvais concept, porté par le mauvais acteur au mauvais moment ?
  • France – Plus de 242 000 personnes se sont inscrites à la troisième édition de l’opération « Mois sans tabac »
  • France – VIH en France : trop d’infections détectées à un stade avancé, les seniors aussi touchés. Un premier préservatif remboursé par l’Assurance maladie
  • Europe – Updates on the presence of TSEs in the EU
  • USA – FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients
  • Chine – Des bébés génétiquement modifiés seraient nés en Chine
  • France – Déclarer et analyser les évènements graves associés à des soins
  • France – La Haute Autorité de Santé annonce les priorités de son projet stratégique 2019-2024
  • Europe – Le Panorama de la Santé Europe 2018
  • France – Conflits d’intérêt : le Formindep obtient l’abrogation par la HAS de sa recommandation sur les dyslipidémies
  • France – La FSPF dénonce un « coup de théâtre » sur la ROSP 2019 et un « micmac autour des médicaments à 15 % »
  • France – La phagothérapie, le nouvel espoir contre la résistance aux antibiotiques
  • France – Le Dossier Médical Partagé est désormais disponible pour tous
  • France – Consommation d’antibiotiques et résistance aux antibiotiques en France : « une infection évitée, c’est un antibiotique préservé ! »
  • France – Mal de dos au travail : L’Assurance Maladie mobilise les entreprises
  • France – Les autorités lancent un plan d’action dans l’affaire des bébés sans bras
  • UK – England sees “steep rise” in measles cases
  • France – Lyme et maladies transmissibles par les tiques : mise au point
  • Wyss Institute to Investigate Sex Disparities With FDA-funded Chip Technology Study
  • Europe – Les bactéries résistantes aux antibiotiques ont fait 33 000 morts en Europe en 2015
  • USA – Scientists Have Grown a Human Retina From Scratch in The Lab
  • France – Les Français vont (enfin!) avoir leur dossier médical partagé
  • France – Le TGI de Toulouse va-t-il condamner Merck à verser des indemnités aux malades sous Levotyrox ?
  • USA – FDA Alerts to Recalls Over Non-Valsartan Product Found to Contain Impurities
  • France – Une étude va évaluer l’efficacité de la cigarette électronique pour arrêter de fumer
  • France – La diffusion publique des données sur la performance des soins de santé peut-elle influencer le comportement des consommateurs, des prestataires de soins de santé et des organisations ?
  • France – Reste à charge zéro et cotisations des complémentaires : les retraités seraient les grands perdants assure une étude de Santiane
  • France – Le PLFSS pour 2019 adopté cette semaine en séance publique par les députés
  • France – Dépakine : Agnès Buzyn veut mieux repérer les familles en vue d’une indemnisation
  • France – PLFSS pour 2019 : réflexions sur les articles 14, 15 et 43
  • France – RESTE À CHARGE ZÉRO EN SANTÉ: LE CONTE DE FÉE N’AURA PAS LIEU !
  • France – Sécurité sociale : le risque du chant du cygne !
  • France – IST : la HAS recommande un dépistage systématique de l’infection à Chlamydia trachomatis chez les jeunes femmes
  • France – Bébés nés sans bras: le gouvernement lance une nouvelle enquête
  • Europe – Vaccin de Sanofi contre la dengue : avis positif pour une autorisation dans l’UE
  • France – Montée en charge des DMP : 60 000 créations de dossiers par semaine surtout par les pharmaciens
  • France – Près d’un Français sur dix est passé par un épisode dépressif en 2017
  • France – Le comité d’alerte sur l’évolution des dépenses d’assurance maladie pousse à de nouvelles mesures de régulations
  • France – Maladies neurodégénératives : les centres d’excellence dynamisent la recherche translationnelle
  • France – Encyclopédie Orphanet du Handicap
  • International – Two Studies May Change View of Probiotics: One Size May Not Fit All
  • France – Cartographie des pathologies et dépenses de l’Assurance maladie : nouveautés et mises à jour disponibles sur ameli.fr
  • France – La mission de préfiguration du « Health Data Hub » remet ses conclusions à Agnès Buzyn
  • France – Campagne 2018 2019 de vaccination contre la grippe. Le SNJMG dénonce l’hyperinflation pour les vaccins
  • France – Signature du nouvel accord-cadre entre l’UNPS et l’Assurance Maladie
  • France – Le PLFSS pour 2019 présenté en conseil des ministres mercredi 10 octobre. Examen en première lecture à l’Assemblée nationale à partir du 23 octobre
  • USA – FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
  • France – Enfants nés sans main. Une succession de cas rarissimes et des questions
  • UK – Brexit and Chemicals Regulation: UK Government Sets Out Plans for a UK-Reach in The Event of a Hard-Brexit
  • International – Acetaminophen may lower odds of febrile seizure recurrence in youths
  • UK – Cost-effectiveness of pediatric leukemia CAR T-cell therapy studied
  • France – Orphadata: une nouvelle plate-forme pour accéder aux données agrégées d’Orphanet
  • UK – Making a success of Brexit
  • Europe – New Council of Europe’s EDQM publication on the donation of oocytes
  • UK – Recardio halts UK heart trial on Brexit uncertainty
  • International – Nobel prize awarded for research on cancer immunotherapy
  • USA – Flu Caused 80,000 Deaths in US Last Year
  • France – Mounir Mahjoubi, secrétaire d’Etat chargé du Numérique, inaugure le premier « HealthTech Center» de France chez Doctolib
  • France – 216 700 interruptions volontaires de grossesse en 2017
  • France – Présentation du projet de loi de financement de la Sécurité sociale pour 2019
  • France – Contribution du Comité consultatif national d’éthique à la révision de la loi de bioéthique 2018-2019
  • USA – Compounding: FDA Revises Insanitary Conditions Guidance, Finalizes Guidance on Radiopharmaceuticals
  • Inernational – The Foundation for a Smoke-Free World : Request for Proposals For New Biomarker Research
  • France – Télémédecine : les représentants des médecins et le DG de la CNAM vigilants face à l’essor des plateformes commerciales
  • France – Emmanuel Macron dévoile son plan « Ma Santé 2022 » pour une transformation profonde du système de santé
  • USA – FTC Charges First Marketer of Intravenous Products
  • USA – E-cigarette warnings to arrive in high school bathrooms nationwide
  • International – Administering Malaria Drugs to Mosquitoes
  • International – Oral Contraceptive Use Link to Childhood Leukemia
  • France – Santé : les dilemmes du placebo
  • France – Les comptes de la santé 2017. La Sécurité sociale toujours plus sollicitée pour le reste à charge
  • USA – No, a Wellness Device Can’t Save Your Life (not Directly, Anyway)
  • Europe – Prostate Cancer Screening: No Effect on Overall Mortality
  • Europe – E-cigarettes: regulations for consumer products
  • USA – FDA Releases Handful of Recent Form 483s
  • Europe – New Recommendations for Hand Osteoarthritis Released
  • France – Androcur : une nouvelle crise sanitaire ?
  • France – Remise du rapport de la mission KIERZEK-LEO sur « l’amélioration de l’information des usagers et des professionnels de santé sur le médicament »
  • USA – Clinicians Should Prescribe Playtime, AAP Says
  • Europe – Low Vitamin D Levels in Painful Diabetic Peripheral Neuropathy
  • USA – Cumulative BP Measures Better for CV Risk Prediction
  • Physician Burnout Jeopardizes Patient Care, Safety
  • Europe – New ESC Guideline on Cardiovascular Disease in Pregnancy
  • USA – New Equation Bests BMI at Estimating Body Fat Mass
  • USA – New Flu Vaccine Recommendations From AAP
  • Europe – High-Sensitivity Troponin Does Not Improve MI Outcomes
  • International – Study discovers immunotherapy could treat some aggressive prostate cancers
  • International – New International Standard for determining infant formula ingredients just published
  • France – Rapport d’information de la commission des affaires sociales de l’Assemblée nationale sur la mise en application de la LFSS pour 2018
  • International – Aspirin disappoints for avoiding first heart attack, stroke
  • USA – AI Speeds Diabetic Retinopathy Diagnosis Without Specialist
  • Study – Novel Multiple Sclerosis Subtype Identified
  • International – Antidepressant Mechanism of Ketamine Revealed?
  • Study – Researchers 3D Print Prototype “Bionic Eye”
  • Discovery – Multimedia Experience to Help Alzheimer’s Patients Connect
  • USA – Pfizer Calls for FDA Guidance to Address False and Misleading Biosimilar Ads
  • Study – More patients survive sudden cardiac arrest with new EMS technique
  • International – HIV/AIDS research yields dividends across medical fields
  • International – Blockchain Token Vouchers for Cannabidiol Products: Interview with CBDoken Founder Alexander Lacina
  • International – AT&T, Softbox and Merck Test Smart Drug Delivery Drones
  • International – Researchers unearth secret tunnels between the skull and the brain
  • USA – Could a New Gut Implant Help Curb Obesity?
  • Étude – Épilepsie : le premier traitement reçu conditionnerait le succès ou l’échec des suivants
  • Public Health – Yeast Powered Radiation Detectors to Keep Clinicians Safe
  • Study – Blood test may identify gestational diabetes risk in first trimester
  • Guideline – Screen All Women Yearly for Urinary Incontinence
  • Study – Type 2 Diabetes Drugs Linked to Bullous Pemphigoid
  • Study – How drugs could repair damage from multiple sclerosis
  • Study – New NIH reference book is one-stop resource for diabetes medical information
  • Study – During HIV infection, antibody can block B cells from fighting pathogens
  • Study – NIH researchers discover highly infectious vehicle for transmission of viruses among humans
  • Study – Obesity extends duration of influenza A virus shedding
  • Study – Fetal DNA sequencing potentially could reduce need for invasive prenatal diagnostic procedures
  • Research – Editing T cell genomes without viruses
• Catégorie : Emplois
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  • Catégorie : Annonces
    • Le Cabinet White-Tillet recrute un(e) : Ingénieur(e) Spécialiste des DM Électro Médicaux et Logiciels
• Catégorie : Formations
  • Règlement Européen 2017/745 des Dispositifs Médicaux – Opérateurs, Dossier Technique, Système Qualité : Nouvelles Exigences
  • Gestion des Risques et Aptitude à l’Utilisation des DM selon le RDM
  • Réglement Européen des Dispositifs Médicaux – Nouvelles exigences, Modalités d’application, Comparaisons avec les directives DM
  • Suivi Clinique Post-Marché ou SCPM – MDD 93/42/CEE et Suivi Clinique après Commercialisation ou SCAC selon Règlement DM UE 2017/745