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SUMMARY:Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop
DESCRIPTION:This annual public workshop hosted by the U.S. Food and Drug Administration (FDA) will provide an overview of ongoing science and research initiatives related to generic drugs\, as well as an opportunity for public input. The workshop supports FDA’s commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of research priorities specific to generic drugs. Input is sought from stakeholders across the generic drug industry\, academia\, patient advocacy groups\, professional societies\, and other interested parties\, and will inform the agency’s Fiscal Year 2027 GDUFA science and research priorities. \nWorkshop discussions will focus on identifying research needs that address scientific knowledge gaps and regulatory challenges impacting generic drug development and assessment\, including complex generics. Public input will also be solicited on the prioritization of product-specific guidances (PSGs). \nKey topic areas include: \n\nLeveraging Generic Drug Industry Expertise & Insights for GDUFA Research & PSG Prioritization\nAddressing Ongoing Challenges with Impurities such as Nitrosamines\nExpanding Regulatory Flexibility with Bioequivalence Approaches and Standards\nUsing Artificial Intelligence (AI) to Address Practical Challenges for Generic Drug Development and Regulatory Assessment\nStandardizing Characterization Test Methods Supporting Bioequivalence and Product Quality\n\nThese sessions are intended to support transparency and collaboration as FDA advances its generic drug research agenda. \nVisit the event page for more information.
URL:https://about.citiprogram.org/event/fiscal-year-2026-generic-drug-science-and-research-initiatives-public-workshop/
LOCATION:Online
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