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USP Opens Four Draft Biologics Method Standards for Early Comment

  • 1.  USP Opens Four Draft Biologics Method Standards for Early Comment

    Community Leadership
    Posted an hour ago

    USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process. This pre-official window is a meaningful opportunity to help shape these methods before they advance toward becoming official standards.

    All four are currently emerging standards (not yet official USP Standards):

    Comments are submitted through USP's Emerging Standards Platform, and input closes 31 August 2026. USP is inviting perspectives from regulators, manufacturers, academia, and healthcare providers.

    If you think AAPS should submit comments on any of these standards, please reach out to your community leaders.

    Learn more: USP announcement



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    Allison Radwick Ph.D.
    Sr Regulatory & Policy Comms Mgr
    USP
    Coatesville 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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