FDA Tunes Cancer Trial Lab Rules: Snore-Worthy Guidance Drop
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: 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 This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Easier Access to Cancer Trials
The FDA published final guidance titled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values" on July 28, 2026. It recommends that sponsors, institutional review boards (IRBs), and clinical investigators choose laboratory-value eligibility criteria carefully so trial participants are not unjustly excluded, and it finalizes the draft issued April 26, 2024.
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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 Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
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