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, however, cannot become qualified without a reliable means to measure it. Therefore the performance characteristics of the test(s) used to provide the biomarker data will be considered. 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.
Please contact CDER-BiomarkerQualificationProgram@fda.hhs.gov for additional questions about the CDER Biomarker Qualification Program.
Biomarker(s) Referenced in Guidance
Issuance Date with Link to Specific Guidance
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
International Life Sciences Institute (ILSI)/ Health and Environmental Sciences Institute (HESI), Nephrotoxicity Working Group
Urinary biomarkers: Alpha-glutathione S-transferase (αGST), Clusterin, Renal Papillary Antigen (RPA-1)
PJ O'Brien, WJ Reagan, MJ York and MC Jacobsen
Serum/plasma biomarkers: Cardiac troponins T (cTnT) and I (cTnI)