Biomarker Guidance and Reference Materials

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

• Guidance Documents
• FDA-Cosponsored Workshops and Events Summary of Supporting Data
• Presentation Slides
• Select Publications
• Biomarker Materials and Informational Websites
• Biomarker Survey

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

• CDER & CBER’s DDT Qualification Project Search database
• Resources for Biomarker Requestors
• More About Biomarkers & Qualification
• General Biomarker Information
• 21st Century Cures Act
• Context of Use (COU)
• Biomarker FAQs
• BEST—a biomarker glossary
• Biomarker Qualification Submissions
• List of Qualified Biomarkers
• Letter of Support

Contact us at: [email protected]