FDA GUIDANCE · FINALApril 10, 2026

Bioanalytical Method Validation for Biomarkers

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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 - Pharmacology

Issue date

April 10, 2026

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