Health Law Daily Wrap Up, CLINICAL RESEARCH—FDA GUIDANCE NOTICES: Cancer Clinical Trial Eligibility Criteria: Laboratory Values; 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: 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 This guidance finalizes the draft guidance of the same title issued on April 26, 2024. (Notice, 91 Fed. Reg. 47245 (July 28, 2026)).

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

FederalRegisterIssuances: FDAGuidanceNotices ClinicalNews DrugBiologicNews