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    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability, (Aug 17, 2026)

    By WK Editorial Staff

    The FDA is announcing the availability of a draft guidance for industry entitled "Container Closure Systems for Human Drugs and Biological Products."

    This guidance document provides guiding principles for evaluating the quality of container closure sy ...

    By WK Editorial Staff

    The FDA is announcing the availability of a draft guidance for industry entitled "Container Closure Systems for Human Drugs and Biological Products."

    This guidance document provides guiding principles for evaluating the quality of container closure systems (CCSs) used to package drugs and biological products, for human use. This guidance includes CCSs that are also device constituent parts of combination products and CCSs used to package the drug or biological product constituent parts of combination products. (FDA Guidance Notice, 91 Fed. Reg. 52700 (Aug. 14, 2026)).

    Dates. Submit either electronic or written comments on the draft guidance by October 13, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    FederalRegisterIssuances: FDAGuidanceNotices DrugBiologicNews

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