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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—FDA GUIDANCE NOTICES: Guidance on essential drug delivery performance characteristics for devices intended to deliver drugs, biological devices updated, (Nov 2, 2026)

    By WK Editorial Staff

    The guidance is intended to facilitate and streamline development and lifecycle management of drug delivery devices.

    The FDA issued a revised draft guidance for industry entitled “Essential Drug Delivery Performance Characteristics for Devices ...

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