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  1. Biomarker Qualification Program

Biomarker Guidances and Reference Materials

Guidance Documents

Qualification Process for Drug Development Tools: Describes the process for qualifying drug development tools intended for potential use, over time, in multiple drug development programs.

NOTE: The process described in the guidance above is no longer current and being rewritten. A new guidance will be published as soon as possible. For more information on the biomarker qualification process described in the 21st Century Cures Act please see:

Recent FDA-Cosponsored Workshops and Events

Biomarker Materials and Informational Websites

Biomarker Survey (Published February 13, 2015)

Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development: Survey Results

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

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