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  1. Drug Development Tool Qualification Programs

Biomarker Survey Results

Biomarker Survey Results

FDA Survey to Identify Potential Biomarkers for Qualification

On February 13, 2015, FDA published a survey in the Federal Register entitled, “Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development.” The purpose of the survey was to seek information to inform the development and qualification of biomarkers in areas related to human drug therapeutics. A total of 74 responses were received either online or via submissions to the docket which closed on May 14, 2015.

See "Compiled Survey Results" below for summary survey results.

Compiled Survey Results (PDF - 207KB)
If additional information is received, the tables will be updated accordingly.

Comments sent to the docket can be found at: Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development

For more information on biomarkers and how to qualify a biomarker:

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