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FDA FY 2026 Generic Drug Science & Research Workshop - Topics for Submission

  • 1.  FDA FY 2026 Generic Drug Science & Research Workshop - Topics for Submission

    Posted 2 hours ago

    Hi all,

    FDA held its annual GDUFA Generic Drug Science and Research Initiatives Public Workshop on June 8–9, 2026 (White Oak, hybrid). Beyond the workshop itself, FDA has an open public docket inviting topic ideas for the FY 2027 GDUFA Science and Research Priorities - and I'd like us to pull together a collective list of topics.

    Why this matters: FDA uses this input to set its FY 2027 research priorities for generic drugs, with a focus on closing scientific knowledge gaps that impact development and regulatory assessment of generics, including complex generics. They're also seeking input on prioritization of product-specific guidances (PSGs).

    This year's sessions focused on identifying research needs in five areas:

    1. Using AI to address practical challenges for generic drug development and regulatory assessment
    2. Leveraging generic drug industry expertise and insights for GDUFA research and PSG prioritization
    3. Addressing ongoing challenges with impurities such as nitrosamines
    4. Expanding regulatory flexibility with bioequivalence approaches and standards
    5. Standardizing characterization test methods supporting bioequivalence and product quality

    What we can do:
    Option 1: Just reply with any topic ideas, research gaps, or PSG priorities you think FDA should address - mapped to one of the five areas above. We'll review all ideas, discuss the finalized list during next regulatory community meeting and decide what to consolidate into an AAPS comment.

    Option 2: If you'd prefer to submit directly to FDA rather than through AAPS, you can comment at the docket link below by the same July 10 deadline.

    Key dates and links:

    Docket comment deadline: 11:59 p.m. ET, July 10, 2026

    Public docket (FDA-2023-N-0119): Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments

    Workshop page: https://www.fda.gov/drugs/news-events-human-drugs/fiscal-year-2026-generic-drug-science-and-research-initiatives-public-workshop-06082026

    Looking forward to your ideas - let's make this a strong, coordinated AAPS contribution.

    Best,
    Bhasker Sambar



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    Bhasker Sambar
    Sr. Manager, External R&D and Technical Services
    Alvogen INC
    Exton PA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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