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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.
- 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
- 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