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  1. Drug Development Tool (DDT) Qualification Programs

Biomarker Qualification Program

Biomarker Qualification Program

SPOTLIGHT 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


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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