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    FDA authorizes Pfizer, Moderna vaccines for youngest children

    The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.   This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Mode...
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    Official encourages ATMP sponsors to consult toolbox guidance to avoid PRIME derailments

    An EU official advised manufacturers of advanced therapy medicinal products (ATMPs) to consult the European Medicines Agency’s (EMA) recently issued “toolbox” guidance to avoid having products rejected from being eligible for accelerated review under the PRIME program for quality-related deficiencies.   Barbara Bonamassa, a reviewer with the Italian Medicines Agency (AIFA), offered an update on some of the EU’s ongoing activities to expedite the development of ATMP the...
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    Former FDA officials call for more transparency for drug approvals

    The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...
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    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 ...
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    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...
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    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...
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    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...
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    Cavazzoni: Pandemic-era tools, learnings are here to stay

    The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency...
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    Recon: FDA staff indicates support for Bluebird gene therapy; FDA expert panel reviews Novavax vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bluebird bio's blood disorder therapy effective - FDA staff ( Reuters ) ( Endpoints ) FDA expert panel weighs Novavax COVID vaccine ( Reuters ) ( WSJ ) FDA advisers recommend authorization of Novavax’s Covid-19 vaccine ( STAT ) Former Lilly manager files whistleblower lawsuit over manufacturing failures at production plant ( STAT ) ( Fierce ) Seres Therapeuti...
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    PIC/S resuming onsite and desktop assessments this year

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced plans to restart assessments for countries applying for membership, though it said these audits will be subject to available resources and other priorities. Such assessments will be conducted either onsite or though desktop assessments.   These plans were shared in the PIC/S 2022 work plan , which discusses the organization’s planned activities through the end of the year or in 2023, including upcomin...
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    Recon: FDA gives thumbs-up to GSK measles vaccine; FDA committee set to review Novavax COVID vaccine EUA on Tuesday

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK measles vaccine gets FDA approval ( Reuters ) ( Endpoints ) ( Biospace ) FDA scientists say Novavax’s Covid-19 vaccine is effective, but also raise concerns ( STAT ) ( Endpoints ) ( InsideHealthPolicy ) Bristol Myers pulls plug on Reblozyl program for rare blood disorder, months after missed PDUFA date ( Endpoints ) 21 Americans Infected With Monkeypox, CD...
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    ICH details milestones reached on guidelines after Athens meeting

    The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.   The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee...