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# Biomarker Qualification Draft Guidance
- URL: https://www.fdaweb.com/biomarker-qualification-draft-guidance/
- Published: 2018-12-11T12:00:00.000Z
- Updated: 2026-09-15T00:50:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143011

FDA has issued a draft guidance, *Biomarker Qualification, Evidentiary Framework*, with recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act, enacted 12/13/16\. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM628118.pdf?ref=fdaweb.com) discusses the evidentiary framework that should be used to support biomarker qualification. FDA says the guidance was informed by public workshops that predated the Cures Act, and describes the needs assessment, context of use, and benefit-risk considerations and how those considerations can relate to determining the type and level of evidence to support biomarker qualification.

The guidance also addresses general statistical and clinical considerations related to the correlation between the biomarker and the outcome of interest, as well as general analytical considerations related to the performance characteristics of the biomarker test.