• Regulatory NewsRegulatory News

    FDA should step in to help spur AI/ML standards: Expert

    The US Food and Drug Administration (FDA) should support the burgeoning integration of artificial intelligence and machine learning (AI/ML) in medical devices by encouraging the development of new standards and setting deadlines for their implementation.   That’s according to Brad Thompson, a regulatory attorney at Epstein, Becker and Green. Thompson spoke with Regulatory Focus on the state of AI/ML and what can be done to help move the regulatory needle forward. Whi...
  • Regulatory NewsRegulatory News

    Back to the drawing board for FDA’s revised quality metrics plan?

    The US Food and Drug Administration’s (FDA) revised plan to collect quality metrics data from manufacturers drew criticism from one major pharmaceutical industry group on the metrics the agency is proposing, as well as its methods for developing the program. Others complained that the proposed program lacks focus, while two industry groups also expressed serious misgivings about the purpose of the overall program.   Yet on a positive note, one industry group and major ...
  • Regulatory NewsRegulatory News

    MDCG urges manufacturers to use MDR transition period wisely

    The European Commission’s Medical Device Coordination Group (MDCG) on Monday said that manufacturers should start preparing now to ensure “timely compliance” with the Medical Device Regulations (MDR) by the time the regulation is fully applicable on 27 May 2024. Devices not certified by this date will no longer have access to the EU market, except in rare circumstances discussed in the notice.   MDCG reiterated that “to ensure that devices can continue to be placed o...
  • ReconRecon

    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...
  • Regulatory NewsRegulatory News

    Study: FDA approves new oncology drugs quicker than EMA

    The US Food and Drug Administration (FDA) is quicker to approve new oncology drugs compared with the European Medicines Agency (EMA), according to a study published 10 June in JAMA Network Open .   Mark P. Lythgoe, MBBS, of Imperial College London, and colleagues performed a cross-sectional study of 89 oncology drugs that were approved in the US and Europe between 2010 and 2019, analyzing how long each drug was reviewed, when the drug was submitted for marketing autho...
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    This Week at FDAThis Week at FDA

    This Week at FDA: User fee moves, COVID vaccine updates, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. There was a lot going on this week on the COVID-19 vaccines front. We made it through the first of several Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings this month on COVID-19 vaccines and have two days of meetings to look forward to next week. We also lear...
  • Regulatory NewsRegulatory News

    All eyes on Senate after House passes user fee reauthorization bill

    The US House overwhelmingly passed its Food and Drug Administration (FDA) user fee reauthorization bill that has been delayed largely due to the COVID-19 pandemic. Now the ball is with the US Senate, which is expected to hold a postponed markup hearing next week on its version of the bill that includes several different provisions.   Unsurprisingly, the House voted 392-28 to approve the user fee reauthorization on 8 June after it had already been approved unanimously b...
  • Regulatory NewsRegulatory News

    Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests

    Peter Marks, director of Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), attributes an increase in the amount of regenerative medicine advanced therapy (RMAT) requests approved for cell and gene therapies to sponsors “getting the hang” of the agency’s expectations for designation requests.   Marks spoke at the California Separation Science Society’s (CASSS) meeting on 8 June on cell and gene therapies. The meeting was h...
  • Regulatory NewsRegulatory News

    Device experts criticize MDUFA V compromise, call for postmarket funding

    The compromise proposal to reauthorize the Medical Device User Fee Amendments (MDUFA V) could put stress on the US Food and Drug Administration’s (FDA) ability to recruit and retain expert personnel and fails to fund critical postmarketing surveillance programs, four medical device policy experts wrote in the New England Journal of Medicine .   The final MDUFA V proposal, which was released on 22 March 2022 after a two-month delay, faces a deadline of 30 September 2...
  • ReconRecon

    Recon: Generic drugmakers face narrow win in price-fixing case; German authority recommends Imvanex monkeypox vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US House passes bipartisan FDA user fee legislation as it aligns with Senate on accelerated approval reforms ( Endpoints ) ( Bloomberg ) Bluebird Bio nears moment of truth as FDA evaluates its gene therapies ( Boston Globe ) Is A Class-Wide Myocarditis Warning Coming For COVID-19 Vaccines? ( Pink Sheet ) Unlike 1-day VRBPAC-to-EUA timeline of peers, Novavax’s Cov...
  • RoundupsRoundups

    Euro Roundup: EFPIA warns of ‘critical challenges’ to starting clinical trials that use IVDs

    Sponsors operating in the EU face “critical challenges” when trying to set up clinical trials that require the use of an in vitro diagnostic (IVD), according to officials at EFPIA, who called on the European Commission to address the challenges to avoid damaging the local clinical trial environment.   In the statement, EFPIA (the European Federation of Pharmaceutical Industries and Associations) voiced its full support for the In Vitro Diagnostic Regulation (IVDR), whi...
  • RoundupsRoundups

    FDA Approvals Roundup: Priorix, Dupixent

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).  New approval  Priorix okayed for preventing measles, mumps and rubella in patients aged 12 or older   GSK’s Priorix (measles, mumps and rubella vaccine, live) has been approved for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals aged 12 months or older.  The efficacy of Priorix was demonstrated based on immunogenicity data ...