Biomarker Qualification Program

SPOTLIGHT 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 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.

Upcoming Public Workshops

For additional information about these workshops, click on the hyperlinks below.

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!

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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

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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

U.S. Food and Drug Administration