• Regulatory NewsRegulatory News

    FDA releases 4 dozen new and updated PSGs

    Four dozen new or updated product-specific guidances (PSGs) were released Monday by the US Food and Drug Administration (FDA). Along with the new and updated guidances, FDA also issued a newly developed infographic that provides a snapshot of the overall PSG program.   “PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug produ...
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    This Week at FDA: New proposed rules, Biocon's Form 483, and more

    We're trying something new at Regulatory Focus , with the goal of gathering the week’s news from (and about) FDA. We'll be covering agency activities and enforcement actions, filings in the Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop-shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. News from this week One of t...
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    FDA issues draft guidance for device software in premarket submissions

    The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions for premarket submissions.   The agency said the guidance recognizes the “rapidly evolving nature of digital health and recent FDA recognized consensus standards related to software” and, when finalized, will serve as an update to the Guidance for the Content of Premark...
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    In US, unlicensed stem cell clinic numbers keep climbing

    Nearly 1,500 US businesses were engaged in direct-to-consumer marketing of unproven and unlicensed stem cell therapies in 2021, marking a significant uptick over the last five years.   The figure comes from an analysis published in the journal Cell Stem Cell that breaks down the number of clinics promoting various types of putative stem cell treatments in the United States between 2016 and 2021. As of March 31, 2021, there were 1,480 U.S. business operating 2,754 c...
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    FDA reiterates support for semi-distributed tracing model under DSCSA

    The US Food and Drug Administration (FDA) recommends that trading partners use the semi-distributed model to trace drug products though the drug distribution chain because of this model’s flexibility and advantages over other data architecture models. The Drug Supply Chain Security Act (DSCSA) requires that trading partners have these systems in place by November 2023.   Connie Jung, acting associate director for policy and compliance in FDA’s Office of Drug Security, ...
  • RoundupsRoundups

    FDA Approvals Roundup: Scemblix, Vuity, Cortrophin Gel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Scemblix okayed for chronic myeloid leukemia with Philadelphia mutation Novartis’s Scemblix (asciminib) has been granted accelerated approval as a therapy for adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML in CP) who have received previous treatment with two or more tyrosine kinase inhibitors (...
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    Wound dressing firm warned for design, environmental control issues

    An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.   CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warnin...
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    FDA issued vaccine EUAs without facility inspections: GAO

    Manufacturers of COVID-19 vaccines currently authorized for emergency use did not undergo facility inspections before their vaccines were authorized by the US Food and Drug Administration (FDA), said the General Accounting Office (GAO) in a new report. However, most facilities had been inspected at least once previously in past 10 years, and the agency relied on a variety of other information sources including record reviews and on-site reviews.   The examination of th...
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    FDA authorizes Pfizer COVID vaccine for younger kids

    The first US emergency use authorization (EUA) for younger children to receive a COVID-19 vaccine has been issued, the US Food and Drug Administration (FDA) announced Friday afternoon.   The mRNA vaccine developed by Pfizer in conjunction with the German firm BioNTech is now authorized for use in children aged 5-11 years. The Centers for Disease Control and Prevention (CDC) will convene a meeting of its immunization advisory committee next week to review clinical param...
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    Improving transparency of regulatory data at EMA, Health Canada, FDA

    Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada (HC) have gotten better at disclosing previously confidential clinical data, a study published in The Journal of Law, Medicine & Ethics has found.     However, each agency discloses this data in a variety of different ways, according to Alexander C. Egilman, with the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital in New Haven, CT,...
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    New public-private consortium will tackle gene therapies for rare diseases

    Two federal agencies are partnering with pharmaceutical companies and non-profit organizations to form a consortium aimed at boosting the development of gene therapies for rare diseases.   In a Wednesday announcement, the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) revealed the launch of the Bespoke Gene Therapy Consortium (BGTC). The consortium’s work will be managed by the Foundation for the NIH and sit within the NIH Acceleratin...
  • RoundupsRoundups

    Approvals Roundup: Xipere, Seglentis, Dupixent

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Xipere okayed for uveitis-associated macular edema Clearside’s  Xipere (triamcinolone acetonide injectable suspension) has been approved for use in the  suprachoroidal space of the eye to treat macular edema associated with non-infectious uveitis.   The approval of the corticosteroid was based on findings from the Phase 3 randomized, mul...