Biomarker Qualification Program


New! Change in Process for Qualification of Drug Development Tools

The process for qualification of drug development tools is changing under new FD&C Act Section 507. FDA is posting information about these updates to the DDT submission processes.

Check for details, documents and information consistent with new section 507(c).

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Learn about Biomarkers, their uses in drug development, and qualifying a biomarker

YouTube icon Watch videos about FDA’s Biomarker Qualification Program

Explore fictional case studies with “real-world” examples to learn more about biomarkers and biomarker qualification in drug development

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The Biomarker Qualification Program was established to support the Center for Drug Evaluation and Research’s (CDER's) work with external stakeholders to develop biomarkers that aid in the drug development process. Through the FDA’s Biomarker Qualification Program, you may request regulatory qualification of a biomarker for a particular context of use in drug development

Biomarkers can be used in a variety of settings, including basic research, drug development, and clinical practice. The Biomarker Qualification Program focuses on biomarkers used in drug development. Once a biomarker is qualified, it can be used in any drug development program under the context for which it obtained qualification. 

The Biomarker Qualification Program is one of the Drug Development Tools (DDT) Qualification Programs created by CDER to provide a framework for development and regulatory acceptance of scientific tools for use in drug development programs. 

About FDA’s Biomarker Qualification Program

The goals of the CDER Biomarker Qualification Program are to:

  • Provide a framework for development and regulatory acceptance of biomarkers for use in drug development
  • Facilitate integration of qualified biomarkers into the regulatory review process
  • Encourage the identification of new and emerging biomarkers for evaluation and use in regulatory decision making
  • Support outreach to stakeholders to encourage biomarker development

A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.

For clarifications of important definitions and explanations of some of the relationships among terms, review the BEST (Biomarkers, EndpointS, and other Tools) Resource and the BEST Resource Fact Sheet.


Biomarker Terminology: Speaking the Same Language

Transcript | Slides (PDF - 1.1MB)


Biomarkers can provide valuable information at various stages of drug development. They have the potential to:

Why qualify a biomarker through the CDER Biomarker Qualification Program?

A qualified biomarker can be used in multiple drug development programs without a need for CDER to reconfirm the suitability of the biomarker’s qualified context of use and has the potential to advance public health by streamlining the drug development paradigm.

What is the process to qualify a biomarker?
The biomarker qualification process consists of three stages: (1) Initiation, (2) Consultation and Advice, and (3) Review.

This flowchart shows the three stages of the biomarker qualification process: Initiation, followed by Consultation and Advice, followed by Review.


Submit a biomarker for qualification

CDER will work collaboratively with submitters through the biomarker qualification process, whether for a single biomarker or for a panel of biomarkers.

Submitters should contact CDER to start the qualification process once they have all of the following:

  • A clear understanding of the relationship between a biomarker and the clinical outcome
  • A defined use for the biomarker in drug development
  • An identified biomarker measurement assay, preferably analytically validated

CDER Biomarker Qualification Case Studies

These fictional case studies on biomarker qualification at FDA's Center for Drug Research and Evaluation (CDER) are intended to help patients, patient advocacy groups, health professionals, small businesses, and pharmaceutical and clinical innovators learn more about the role of biomarkers and biomarker qualification in drug development. Learning objectives of the case studies include:

  • Understand the role of biomarker qualification in drug development.
  • Understand the validation studies necessary to support the qualification of a biomarker for use in drug development.
  • Understand the collaborative efforts involved in qualification of a biomarker for a specific context of use.

Information for biomarker qualification submitters
Learn about the biomarker qualification submission process, including the action items, expectations, resources, and tools necessary to qualify a biomarker.

Submission Assistance
For more information, contact FDA CDER:
Email: CDER-BiomarkerQualificationProgram@fda.hhs.gov
Phone: 301-796-2600


Page Last Updated: 07/19/2017
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