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FDA revised draft PSGs for generic peptides (comments due 28 Sep 2026)

  • 1.  FDA revised draft PSGs for generic peptides (comments due 28 Sep 2026)

    Posted 2 hours ago

    The FDA published 17 revised draft product-specific guidances (PSGs) for peptide products   for public comment (posted 28 July 2026). The comment deadline is 28 September 2026.

    The revised draft PSGs from FDA's Office of Generic Drugs address ANDA development for peptide products, including semaglutide, tirzepatide, liraglutide, teriparatide, pegcetacoplan, glucagon, dasiglucagon, calcitonin salmon, and vosoritide. Key updates cover peptide manufacturing routes, innate immune response testing, impurity thresholds, higher-order structure, biological activity, and comparison with the reference-listed drug.

    These revisions span several areas: regulatory science, pharmaceutical quality/CMC, analytical characterization, biologics/biosimilars, and immunogenicity. FDA has also withdrawn its May 2021 guidance on certain highly purified synthetic peptide drug products, with a revision planned this year.

    The announcement is here: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products (Federal Register notice 91 FR, 29 July 2026).



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    Subathra Ramamoorthy
    Associate Principal Scientist
    Veranova
    Westford MA
    [email protected]

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