SPOTLIGHT Events & Announcements
Upcoming Public Workshops
For additional information about these workshops, click on the hyperlinks below.
November 9, 2023: Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation
February 22, 2024: Biomarker-driven Drug Development for Allergic Diseases and Asthma
To locate a project or a qualified biomarker go to CDER & CBER’s DDT Qualification Project Search database
Web content is updated for consistency with 21st Century Cures Act!
Get Started with your submission:
The mission of the CDER Biomarker Qualification Program (BQP) is to work with external stakeholders to develop biomarkers as drug development tools. Qualified biomarkers have the potential to advance public health by encouraging efficiencies and innovation in drug development.
- Support outreach to stakeholders for the identification and development of new biomarkers
- Provide a framework for the review of biomarkers for use in regulatory decision-making
- Qualify biomarkers for specific contexts of use that address specified drug development needs
- CDER & CBER’s DDT Qualification Project Search database
- Resources for Biomarker Requestors
- About Biomarkers
- More About Biomarkers & Qualification
- General Biomarker Information
- 21st Century Cures Act
- List of Qualified Biomarkers
- Biomarker Qualification Submissions
- Letter of Support
Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov