Bioanalytical Method Validation for Biomarkers

Issue Date: April 10, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final

Bioanalytical Method Validation for Biomarkers

This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), as applicable, to validate bioanalytical methods used to evaluate biomarker concentrations. This guidance can also inform the development of bioanalytical methods used for the analysis of biomarker concentrations in nonclinical study samples.

Download the Guidance Document

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