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  1. Drug Development Tool (DDT) Qualification Programs

Biomarker Qualification Program

Spotlights Events & Announcements

The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now closed. The FY 2025 DDT Grant Cycle is accepting applications 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 available here: https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html. 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

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Resources for Biomarker Requestors


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



  • 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

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

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