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New Proposed FDA Immunogenicity Drug Product Labeling Guidance

  • 1.  New Proposed FDA Immunogenicity Drug Product Labeling Guidance

    Posted 06-29-2022 14:30
    Hi Everyone,
    I am preparing a presentation focusing on the industry impact of the FDA Draft Guidance for immunogenicity labeling and was wondering what thoughts anyone might have regarding this guidance?  The Draft Guidance is available at the FDA website and was issued FEB 2022 Docket Number FDA-2021-D-1041.  I want to make sure I want to make sure I do not miss anything important in my presentation.
    If you have a moment, please respond to this thread!
    Thanks,
    Steve

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    Steven Swanson Ph.D., FAAPS
    Sr Principal Scientist
    Genentech
    South San Francisco CA
    [email protected]

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