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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 08-09-2026 07:50

    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 FDA has also withdrawn its May 2021 guidance on certain highly purified synthetic peptide drug products, with a revision planned this year.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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  • 2.  RE: FDA revised draft PSGs for generic peptides (comments due 28 Sep 2026)

    Posted 28 days ago

    Dear AAPS Pharmaceutical Quality team,

    AAPS (led by the Translational and Clinical Science Community) is going to convene to submit comments, generally, on these 17 PSGs for peptide products. The team is meeting Aug 19 at 1pm EST.

    Do we have any PQ members who wish to join this team? There may be an opportunity for the BCBP members, should anyone be interested.

    Please let me know ASAP!

    Thanks,

    Joe



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    Joseph Thomas
    Quality Intelligence and Advocacy Lead
    Sanofi
    Bolton 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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