Bioanalytical Method Validation for Biomarkers

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.

BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET

BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET