The Food and Drug Administration (FDA, the Agency, or we) 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 Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
US Federal Register - FDA Guidance Notices · July 28, 2026
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators
Original title: Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
FDA finalizes guidance on washout periods and concomitant medication exclusions in cancer clinical trial eligibility criteria.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.