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    • HEALTH CARE REIMBURSEMENT NEWS—Federal rule targets IDR process inefficiencies with new disclosure and communication mandates
    • ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Statistical approaches to establishing bioequivalence guidance issued
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Hospice enrollment denied after it failed to demonstrate operational status
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    Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Statistical approaches to establishing bioequivalence guidance issued, (Jun 1, 2026)

    By WK Editorial Staff

    The guidance finalizes a draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.

    The FDA issued a final guidance for industry entitled “Statistical Approaches to Estab ...

    By WK Editorial Staff

    The guidance finalizes a draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.

    The FDA issued a final guidance for industry entitled “Statistical Approaches to Establishing Bioequivalence” that provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and amendments and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations (Notice, 91 Fed. Reg. 32056 (May 29, 2026)).

    Dates. The announcement of the guidance is published in the Federal Register on May 29, 2026.

    FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews

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