• RoundupsRoundups

    EU Regulatory Roundup: ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work   The European Parliament’s health committee has renewed its call for the region’s drug regulator to be given more money and staff. ENVI, the Committee on the Environment, Public Health and Food Safety, made the comment in its opinion about the European Union’s 2020 budget proposal.   Pascal Ca...
  • Regulatory NewsRegulatory News

    Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

    Research published this week in PLOS Medicine raises concerns about the use of surrogate endpoints to support the marketing authorizations of products assessed via the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA) and accelerated assessment (AA) pathways. The use of the CMA and AA pathways, which is restricted to situations of “unmet medical need” and/or “in the interests of public health,” are often based on incomplete benefit-risk asses...
  • ReconRecon

    Recon: Court let Merck Hide Propecia Data; Sanofi to Pay Lexicon $260M to end Partnership

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Court let Merck hide secrets about a popular drug’s risks ( Reuters ) Why Aren’t There Better Cancer Drugs? Scientists May Have Picked the Wrong Targets ( NYTimes ) ( STAT ) ( Science ) ( Study ) ICER dings Novo's new oral diabetes drug ( BioPharmaDive ) Purdue Close to Settlement with Cities and Half of States Over Opioid Crisis ( WSJ ) ( Reuters ) ( CNBC ) ...
  • Regulatory NewsRegulatory News

    When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates

    A new study in JAMA Network Open finds that drugs and medical devices approved by the US Food and Drug Administration (FDA) based solely on non-randomized controlled trials (RCTs) exhibited larger effect sizes compared to products that required further study in randomized trials. But the authors called for greater FDA transparency to instill confidence that decisions about drug and device approvals based on observational data are appropriate.   The goal of the study,...
  • Regulatory NewsRegulatory News

    EC Explains New MDR, IVDR Rules for Designating Expert Device Panels

    The European Commission (EC) on Wednesday published an implementing decision on how new medical device expert panels will be designated under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The panels will provide scientific, technical and clinical assistance to the EC, the Medical Device Coordination Group (MDCG), member states, notified bodies and device manufacturers. In particular, the implementing decision notes that notified bodies ...
  • Feature ArticlesFeature Articles

    The Essential IVDR and the Challenges it Presents

    This article discusses key elements of the In Vitro Diagnostic Regulation (IVDR) and the challenges it presents to manufacturers. The author covers device classification changes, oversight, clinical evidence and performance evaluation, and postmarket vigilance. She cautions about the effects of notified body reductions and the consequences. She concludes by warning that significant changes may impede market launch for some products.   Introduction   It is essential...
  • Regulatory NewsRegulatory News

    Novartis Inhaler is First Device to be Certified Under MDR

    BSI’s UK notified body announced Wednesday that the Novartis Concept1 inhaler is the first device to be certified under the new EU Medical Devices Regulation (MDR). While previously classified as a Class I device, meaning it did not need to be reviewed by a notified body, the inhaler is now a Class IIa device under Rule 20 of MDR, which requires the notified body review. Gary Slack, SVP of medical devices at BSI said:  “As a result of being the first designated EU N...
  • Regulatory NewsRegulatory News

    EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

    European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from Cyprus, to lead the health portfolio. Moving forward, Kyriakides’s leadership will be crucial in the implementation of the EU Medical Devices Regulation (MDR), which has a looming implementation deadline next May, and the In Vitro Diagnostics Regulation (IVDR), which has an implement...
  • Regulatory NewsRegulatory News

    GAO Reports on FDA, Drugmaker Efforts to Boost Access to Investigational Drugs

    A new report from the Government Accountability Office (GAO) finds that drugmakers and other stakeholders are largely supportive of steps taken by the US Food and Drug Administration (FDA) to facilitate access to investigational drugs, both through clinical trials and via expanded access or right-to-try requests.   Specifically, the report looked at actions FDA has taken to broaden clinical trial eligibility, improve access to investigational drugs outside of clinical ...
  • Regulatory NewsRegulatory News

    CDRH Committee Discusses Challenges in Communicating Cybersecurity Concerns

    The US Food and Drug and Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday convened its Patient Engagement Advisory Committee (PEAC) to discuss the difficulties and challenges in communicating cybersecurity safety risks and threats. Since 2013, CDRH has released safety communication related to eight device cybersecurity concerns, although the center notes that issues are customarily disclosed when there is a software update to fix an is...
  • Regulatory NewsRegulatory News

    FDA Warns Drug Manufacturers as FTC Warns CBD Advertisers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to South Korea-based drug manufacturer Enprani Co. and China-based drug manufacturer Hangzhou Badi Daily Use Chemical Company. Meanwhile, the Federal Trade Commission (FTC) on Tuesday said it sent warning letters to three unnamed companies for illegal advertising of products containing cannabidiol (CBD). The letter for Enprani, which follows a five-day inspection last March, shows how...
  • ReconRecon

    Recon: Pelosi’s Drug Pricing Plan Includes Medicare Negotiation, International Price Index; Mallinckrodt to Sell BioVectra for $250M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi’s drug pricing plan is more aggressive than expected ( STAT ) ( NYTimes ) ( Washington Post ) ( CNBC ) ( The Hill ) US judge allows public nuisance claim in opioid trial ( Reuters ) Sackler Family To Give Up Value Of Purdue Pharma To Settle Opioid Claims ( NPR ) Delaware DOJ files lawsuit against Sackler family, owners of Purdue Pharma companies ( Delaw...