Biomarker Qualification Program

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 Biomarker Qualification movie transcript

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 (PDF - 86KB)

Slides (PDF - 1.1MB)

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

  • Reduce the time required to complete clinical trials
  • Reduce the sample sizes required to achieve statistical significance
  • Provide valuable information that could reduce uncertainty in regulatory decisions

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 qualificationAnnouncement: Publication of Framework Document for Defining Evidentiary Criteria for Biomarker Qualification

Additional resources for submitting a biomarker for qualification:

Contact Us

For questions about the CDER Biomarker Qualification Program, please contact CDER-BiomarkerQualificationProgram@fda.hhs.gov

Qualified Biomarkers and Supporting Information:

General AreaSubmitterBiomarker(s) Qualified for Specific Contexts of UseIssuance Date with Link to Specific GuidanceGuidance TypeSupporting Information


Predictive Safety and Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)

Urinary biomarkers: Albumin, β2- Microglobulin, Clusterin, Cystatin C, KIM-1, Total Protein, and Trefoil factor-3

4/14/2008 Drug-induced Nephrotoxicity Biomarkers




International Life Sciences Institute (ILSI)/ Health and Environmental Sciences Institute (HESI), Nephrotoxicity Working Group

Urinary biomarkers: Clusterin, Renal Papillary Antigen (RPA-1)

9/22/2010 Drug-induced Nephrotoxicity Biomarkers




PJ O'Brien, WJ Reagan, MJ York and MC Jacobsen

Serum/plasma biomarkers: Cardiac troponins T (cTnT) and I (cTnI)

2/23/2012 Drug-induced CardiotoxicityBiomarkers



 ClinicalMycoses Study GroupSerum/bronchoalveolar lavage fluid biomarker: Galactomannan11/14/2015 Patient selection biomarker for enrollment in Invasive Aspergillosis (IA) clinical trialsFinal


 ClinicalChronic Obstructive Pulmonary Disease (COPD) Biomarker Qualification Consortium (CBQC)Plasma biomarker: Fibrinogen9/14/2016 Prognostic biomarker for enrichment of clinical trials in Chronic Obstructive Pulmonary Disease (COPD)  Final



 ClinicalPolycystic Kidney Disease Outcomes ConsortiumImaging Biomarker: Total Kidney Volume (TKV)9/15/2016 Prognostic biomarker for enrichment of clinical trials in Autosomal Dominant Polycystic Kidney Disease. FinalReviews

 *Qualification determinations issued prior to publication of Guidance for Industry:  Qualification Process for Drug Development Tools

Page Last Updated: 12/21/2016
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