Biomarker Qualification Program
Spotlights Events & Announcements
The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open. The FY 2024 DDT Grant Cycle is accepting applications through May 13, 2024 and FY 2025 through May 13, 2025. For additional information on how to apply for a DDT Research Grant, go to the “Drug Development Tools Research Grants (U01) Clinical Trial Optional" announcement. If you have any questions regarding DDT Research Grants, please email CDER-DDTGrantsContracts@fda.hhs.gov.
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!
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Resources for Biomarker Requestors
Mission
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.
About FDA’s Biomarker Qualification Program
Goals
- 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
Additional Information
- 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