FDA GUIDANCE · FINALDecember 15, 2025

Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Clinical - Medical

Issue date

December 15, 2025

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