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GUIDANCE DOCUMENT

Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff December 2018

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Biomarker Qualification: Evidentiary Framework

Docket Number:
2018-26900
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Biomarker Qualification: Evidentiary Framework.” This draft guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, that added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Qualification of a biomarker is a determination that within the stated context of use, the biomarker can be relied on to have a specific interpretation and application in drug development and regulatory review.

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All written comments should be identified with this document's docket number: 2018-26900.