Bioanalytical Method Validation for Biomarker Concentrations Guidance
Summary
FDA's Center for Drug Evaluation and Research issued guidance FDA-2017-D-6821 to help sponsors validate bioanalytical methods used to evaluate biomarker concentrations in drug and biologic development programs. The guidance applies to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). It addresses method validation for biomarker analysis in both clinical study samples and nonclinical study samples.
What changed
FDA's Center for Drug Evaluation and Research issued guidance document FDA-2017-D-6821 providing recommendations for validating bioanalytical methods used to evaluate biomarker concentrations. The guidance addresses sponsors of investigational new drug applications, new drug applications, biologics license applications, and abbreviated new drug applications. It also informs development of bioanalytical methods for nonclinical study sample analysis.
Pharmaceutical companies and clinical investigators conducting biomarker studies should review these recommendations and incorporate appropriate validation standards into their analytical procedures. As non-binding guidance, organizations are encouraged to submit comments through the regulatory docket to provide feedback on the guidance recommendations.
What to do next
- Review guidance for bioanalytical method validation requirements
- Update biomarker analysis procedures to align with FDA expectations
- Submit comments through regulations.gov or mail to Dockets Management
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Guidance Documents
Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research 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.
Submit Comments
Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6821.
- ## Content current as of:
04/10/2026
Regulated Product(s)
- Drugs
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