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  • 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
  • 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  • USA – Competitive Generic Therapy Designations: FDA Explains Process in New Draft Guidance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 – 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
  • 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
    • 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 – 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 – 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
• Catégorie : Cosmétiques
  • Catégorie : France
    • 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 – 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
    • 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 – 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
  • SpringFest One Fashion Show at the University of Michigan
  • How To Use Basic Design Principles To Decorate Your Home
  • Creative decorating with houseplants, from floor to ceiling
  • Bayside Ranch a perfect canvas for interior designer 2016
  • 7 unique egg decorating ideas for you to try this Easter
  • 10 Ways to Make Extra Money as a Graphic Designer
  • Design better graphics with The Premium Photoshop Add-On Bundle
  • After Effects Guru: Tracking and Stabilizing Footage
  • Home Run Kitten Favored in Competitive San Simeon
  • Catégorie : Annonces
    • Le Cabinet White-Tillet recrute un(e) : Ingénieur(e) Spécialiste des DM Électro Médicaux et Logiciels
• Catégorie : Formations
  • 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
  • Applis en Santé & Objets Connectés – Clés Légales/Réglementaires & Impact des Nouveaux Règlements Européens DM & DMDIV
  • Sécurité Biologique des Dispositifs Médicaux
  • Réglement Européen des Dispositifs Médicaux – Nouvelles exigences, Modalités d’application, Comparaisons avec les directives DM
  • Comment se préparer aux audits ISO EN 13485 :2016 et les points clés du MDSAP
  • Tests Diagnostiques Compagnons – Du développement à l’accès au marché