• Regulatory NewsRegulatory News

    Industry asks FDA to expand scope of product quality assessment guidance

    Corrected 21 July 2022 to make a clarification about the products subject to the industry comments.   Stakeholders want the US Food and Drug Administration (FDA) to include biosimilars, as well as certain biologics regulated by the Center for Biologics Evaluation and Research (CBER), in the agency’s guidance on benefit-risk principles when evaluating product quality assessments.   In May, FDA published the Benefit-Risk Considerations for Product Quality Assessm...
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    European Commission proposes overhaul of blood, tissues and cells regulation

    The European Commission (EC) last week proposed to overhaul the EU’s regulations on substances of human origin (SoHO) to improve the quality and safety of substances that are part of treatments and therapies like blood transfusions, stem cell transplants for blood cancers and medically assisted reproduction therapies such as in vitro fertilization (IVF).   The regulation, which is part of the European Health Union initiative, would not only cover better quality and saf...
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    Recon: CDC says monkeypox vaccine demand exceeds supply; NIH’s Fauci to retire by end of Biden’s term

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Demand for Monkeypox Vaccine Exceeds Supply, C.D.C. Says ( NYT ) ( Politico ) US Buys More Monkeypox Vaccine, Ramps Up Testing as Cases Rise ( Bloomberg ) ( Endpoints ) NYC will use a one-dose monkeypox vaccine strategy to stretch supplies, despite FDA, CDC warnings against the move ( STAT ) ( Politico ) Covid-19 public health emergency extended in the US ( CN...
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    This Week at FDA: User fee reauthorization hits a snag, Novavax EUA, 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. This week, top Republican on the Senate health committee introduced a “clean” FDA user fee reauthorization bill that could throw a wrench into the already tight timeframe for the package. We also saw FDA authorize Novavax’s adjuvanted COVID-19 vaccine and learned that the agency has dela...
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    FDA finalizes instructions for use guidance for drugs, biologics

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the content and format of Instructions for Use (IFU) labeling for pharmaceutical manufacturers to help consumers understand complicated instructions for using a drug or a biologic.   The guidance covers human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA)....
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    Burr introduces stripped-down user fee bill

    Updated 14 July 2022 to include a statement from Sen. Patty Murray (D-WA).   Up against a tight timeline and divergent user fee reauthorization bills in the two chambers of Congress, Senate Health, Education, Labor and Pensions (HELP) committee Ranking Member Richard Burr (R-NC) on Thursday introduced a “clean reauthorization” bill that strips out several riders from the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act .   The alterna...
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    Recon: FDA delays decision on Beigene drug due to COVID restrictions; Pfizer seeks Japanese approval for COVID vaccine in young children

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis, BeiGene’s PD-1 drug the latest to hit FDA wall as pandemic stalls another review ( Fierce ) ( Reuters ) FDA again spells out safety concerns with oral type 1 diabetes drug while denying Lexicon's attempt to overturn a CRL ( Endpoints ) In post-Roe guidance, HHS tells 60,000 pharmacies: Don't stop dispensing abortion drugs ( Endpoints ) ( Reuters ) Ab...
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    Euro Roundup: EMA drug shortage group backs continued COVID exceptions

    The regulatory flexibilities offered to ease the impact of COVID-19 should be continued for now, according to the members of the European Medicines Agency’s (EMA) Medicines Shortages Steering Group (MSSG). The group, formed earlier this year to plan for future crisis preparedness, met for the fourth time on 7 July.   EMA, the Heads of Medicines Agency, and the European Commission adopted the measures in 2020 to accelerate the authorization of COVID-19 interventions, su...
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    MDCG offers guidance on Eudamed workarounds for IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Wednesday issued guidance on administrative practices and alternative technical solutions on the application of certain In Vitro Diagnostic Regulation (IVDR) provisions in the absence of a fully functional Eudamed system.   The guidance comes just two months after IVDR went into effect and follows a similar guidance on Eudamed administrative practices and alternative solutions under the Medical De...
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    FDA cybersecurity draft guidance draws concern from patients, industry

    The US Food and Drug Administration (FDA) has received more than 1,800 comments from the public, medical device manufacturers, and other stakeholders concerning its draft guidance on cybersecurity when it comes to quality systems and premarket submission content for medical devices.   This is not the agency’s first attempt at publishing an updated draft guidance on this topic: in April 2022, FDA created an entirely new draft guidance after receiving public comments onl...
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    Recon: FDA authorizes Novavax vaccine; EMA re-elected ICMRA chair

    Updated 13 July 2022 to note FDA's issuance of an emergency use authorization (EUA) for Novavax's adjuvanted COVID-19 vaccine. Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine ( FDA ) FDA to authorize Novavax's Covid-19 vaccine ( Politico ) Novo Nordisk's new weight loss drug Wegovy needs a 'significant discount,' ICER says ( Fierce ) Endo Moving ...
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    EMA to explore reviewing raw data from clinical trials in applications

    The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.   The pilot , announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. On...