2/1/24, 8:02 PM Biomarker Qualification Program | FDA

Biomarker Qualification Program

SPOTLIGHT Events & Announcements

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 (/news-
events/fda-meetings-conferences-and-workshops/biomarker-driven-drug-development-allergic-
diseases-and-asthma-public-workshop-02222024)

To locate a project or a qualified biomarker go to CDER & CBER’s DDT Qualification Project Search
database (https://fda.force.com/ddt/s/)  (http://www.fda.gov/about-fda/website-policies/website-
disclaimer)

Web content is updated for consistency with 21st Century Cures Act (/drugs/drug-development-tools-
qualification-programs/21st-century-cures-act-qualification-drug-development-tools)!

Get Started with your submission:

Resources for Biomarker Requestors (/drugs/biomarker-qualification-program/resources-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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About FDA’s Biomarker Qualification Program

Transcript (/drugs/biomarker-qualification-program/transcript-about-fdas-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

CDER & CBER’s DDT Qualification Project Search database (https://fda.force.com/ddt/s/) 

(http://www.fda.gov/about-fda/website-policies/website-disclaimer)
Resources for Biomarker Requestors (/drugs/biomarker-qualification-program/resources-biomarker-
requestors)

About Biomarkers (/drugs/biomarker-qualification-program/about-biomarkers-and-qualification)

More About Biomarkers & Qualification (/drugs/biomarker-qualification-program/more-about-
biomarkers-qualification)
General Biomarker Information (/drugs/biomarker-qualification-program/general-biomarker-
information) 
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21st Century Cures Act (/drugs/drug-development-tools-qualification-programs/21st-century-cures-

act-qualification-drug-development-tools)

List of Qualified Biomarkers (/drugs/biomarker-qualification-program/list-qualified-biomarkers)

Biomarker Qualification Submissions (/drugs/biomarker-qualification-program/biomarker-
qualification-submissions)
Letter of Support (/drugs/biomarker-qualification-program/letter-support-los-initiative)

Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov (mailto:CDER-

BiomarkerQualificationProgram@fda.hhs.gov)

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