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        Drug Development Tool (DDT) Qualification Programs

Biomarker Qualification Program Home
          Drugs
          Development & Approval Process | Drugs
          Drug Development Tool (DDT) Qualification Programs
          Biomarker Qualification ProgramDrug Development Tool (DDT) Qualification Programs Biomarker Qualification Program
  	
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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!

**Get Started with your submission:**

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**

Transcript

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 needsAdditional Information



CDER & CBER’s DDT Qualification Project Search database
	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 SupportContact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov

                                                                                  Content current as of:
      01/22/2024
                  
                   
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