Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
Published Date: 7/28/2026
Notice
Summary
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 Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA finalizes cancer trial washout guidance
On July 28, 2026, the FDA issued final guidance titled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications" that gives recommendations to sponsors, institutional review boards (IRBs), and clinical investigators about using washout periods and excluding concomitant medications in cancer drug trials. The guidance finalizes the April 26, 2024 draft and notes that unnecessarily restrictive eligibility criteria can slow patient enrollment and limit patients' access to clinical trials.
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Previous / Next Documents
Previous: 2026-15185, Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." 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 guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
Next: 2026-15187, Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
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: Laboratory Values." 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 guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial participants. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.