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U.S. Department of Health and Human Services

Drugs

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Biomarker Qualification Program

The Biomarker Qualification Program was established to support CDER’s work with external scientists and clinicians in developing biomarkers. As an inter-Office collaborative endeavor within CDER, the Biomarker Qualification Program offers a formal process to guide submitters as they develop biomarkers and rigorously evaluate them for use in the regulatory process.

The goals of the CDER Biomarker Qualification Program are to:

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

Biomarkers being considered for qualification are conceptually independent of the specific test performing the measurement. A biomarker cannot become qualified without a reliable means to measure it.  However, FDA clearance of a testing device for marketing does not imply that the biomarker it measures has been demonstrated to have a qualified use in drug development and evaluation.  Additionally, qualification of a biomarker does not automatically imply that a specific test device used in the qualification process for a biomarker has been reviewed by FDA and cleared or approved for use in patient care.  

The biomarker may also have potential value outside the boundaries of the qualified context of use.  As data from additional studies are obtained over time, submitters of biomarkers will be able to continue working with the Biomarker Qualification Program to submit additional data and expand the qualified context of use. 

Qualified DDT:

 DDT Type  Name Submitter Qualification Date Link to Supporting Information
 Biomarker  Seven Biomarkers of Drug-Induced Nephrotoxicity in Rats  Predictive Safety and Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)  4/14/2008  Predictive Safety Testing Consortium (PDF - 163KB)
 Biomarker  Nonclinical Qualification of Urinary Biomarkers of Nephrotoxicity  International Life Sciences Institute (ILSI)/ Health and Environmental Sciences Institute (HESI), Nephrotoxicity Working Group  9/22/2010  HESI  Nephrotoxicity Qualification (PDF - 234KB)
 Biomarker  Nonclinical Qualification of Circulating Cardiac Troponins T and I as Biomarkers of Cardiac Morphologic Damage  PJ O'Brien, WJ Reagan, MJ York and MC Jacobsen  2/23/2012  Biomarker Qualification Decision (PDF - 144KB)

  

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