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    • DRUGS AND BIOLOGICS—D.D.C.: BOTOX as a biological product should have been excluded from price negotiations
    • ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Guidance on essential drug delivery performance characteristics for devices intended to deliver drugs, biological devices updated
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    • ADMINISTRATION OF FDC ACT—NOTICES: FDA extends effective date of final resolution of drug efficacy study implementation 7661
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    Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: FDA extends effective date of final resolution of drug efficacy study implementation 7661, (Nov 2, 2026)

    By WK Editorial Staff

    The further extension is necessary to allow FDA sufficient time to consider issues raised by interested parties.

    The FDA is extending the effective date of the notice published in the Federal Register on May 27, 2026, titled Drugs for Human Use; Drug ...

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