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:
- 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
- Status of Biomarker Qualification Submissions
- Letter of Support
Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov