Health Law Daily Wrap Up, CLINICAL RESEARCH—FDA GUIDANCE NOTICES: Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability, (Jul 30, 2026)

By WK Editorial Staff

The Food and Drug Administration is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications."

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024. (Notice, 91 Fed. Reg. 47247 (July 28, 2026)).

Dates. The announcement of the guidance is published in the Federal Register on July 28, 2026.

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