Issue Date: July 27, 2026
Issued by: Oncology Center of Excellence
Topic(s): Clinical Trials
Status: Final
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry, IRBs, and Clinical Investigators
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. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
Download the Guidance Document
