• Regulatory NewsRegulatory News

    This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more

    Welcome to Week 2 of This Week at FDA . We've again gathered the week’s news from (and about) FDA. Each Friday, 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. The House Committee on Oversight ...
  • Regulatory NewsRegulatory News

    Study: RWD not ready for postapproval prime time

    For drugs and biologics that receive accelerated approval, could information drawn from real-world data sources supplant traditional postapproval clinical trials to confirm that the therapies have benefit? Real-world data (RWD) are not yet robust enough to confirm the benefit of drugs awarded accelerated approval based on surrogate endpoints, answered the authors of a recent study.   “The findings of this cross-sectional study suggest that none of the 50 [Food and Drug...
  • Regulatory NewsRegulatory News

    FDA touts success and challenges in biosimilar development

    A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the program in the oncology space, with less activity in other treatment areas. The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake.   Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation...
  • RoundupsRoundups

    FDA Approvals Roundup: Eprontia, Dyanavel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Eprontia okayed as liquid form for treating epilepsy and migraine Azurity’s Eprontia (topiramate) oral solution has been approved for treating seizures and migraines. The approval covers use of the anticonvulsant as a monotherapy and adjunctive therapy for seizures in patients aged 2 years or older and as a preventive treatment for migraine in...
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    Friends of Cancer Research urges early dose-finding studies to reduce treatment toxicity

    Friends of Cancer Research is calling on all stakeholders in the cancer community to move away from the idea of “more is better” in drug dosing and begin to incorporate dose-finding studies into the cancer trial process.   Dose optimization is the focus of a new white paper that the group released at its 25 th annual meeting. The paper offers recommendations for performing adequate dose optimization studies in oncology, with a focus on the pre-market setting. “These...
  • Feature ArticlesFeature Articles

    Effectiveness of the rare pediatric disease priority review voucher program

    The US Food and Drug Administration (FDA) awards priority review vouchers (PRVs) as an incentive to encourage development of therapeutics for underserved medical needs. The program, introduced in 2007 for neglected tropical diseases, was expanded to include rare pediatric diseases in 2012 and medical countermeasures in 2016. Of these three programs, the most successful has been for rare pediatric diseases, with studies indicating the pediatric PRV program stimulates clinic...
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    Real-world evidence from EHR supports antimicrobial resistance fight

    An automated system that extracts real-world data from the electronic health record is as efficient as manual data extraction in gathering real-world data to support research into antibiotic resistance, according to a new report on research supported by the US Food and Drug Administration (FDA).   The data extraction project, supported by FDA through the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), began with investigators from the Johns H...
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    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA taking incremental approach to launching KASA reviews

    The US Food and Drug Administration (FDA) is taking a “step-wise” approach to implementing its Knowledge-Aided Assessment and Structured Application (KASA) drug review program. The review program has already launched for abbreviated new drug applications (ANDAs) for solid oral dosage forms and will eventually be rolled out for new drug applications (NDAs) and ANDA liquid dosage forms in FY 2023. KASA will be phased in for investigational new drug applications (INDs) and po...
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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...
  • Regulatory NewsRegulatory News

    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...