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  1. Drug Development Tool Qualification Programs

General Biomarker Information

General Biomarker Information

Biomarker Guidance and Reference Materials

This page provides information on biomarkers used as drug development tools along with information on the following topics:

Videos and Podcasts on FDA’s Biomarker Qualification Program

This page provides informative videos and podcasts describing biomarkers as drug development tools, and qualification of biomarkers at CDER.

Important Information for Requestors

Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov