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    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: FDA issues draft guidance regarding oncology clinical trials, (Aug 19, 2025)

    By WK Editorial Staff

    The FDA announced the availability of a draft guidance for industry entitled “Approaches to Assessment of Overall Survival in Oncology Clinical Trials.”

    The purpose of this draft guidance is to provide recommendations to sponsors on the ...

    By WK Editorial Staff

    The FDA announced the availability of a draft guidance for industry entitled “Approaches to Assessment of Overall Survival in Oncology Clinical Trials.”

    The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified safety endpoint. While the draft guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this draft guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint (Notice, 90 Fed. Reg. 40367 (Aug. 19, 2025)).

    Dates. Submit either electronic or written comments on the draft guidance by October 20, 2025.

    FederalRegisterIssuances: FDAGuidanceNotices FDCActNews ClinicalNews DrugBiologicNews PrescriptionDrugNews

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