Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence
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March 25, 2024
Spotlights Events & Announcements
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
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
Contact us at: [email protected]
