GUIDANCE DOCUMENT
Biomarker Qualification: Evidentiary Framework Draft Guidance for Industry and FDA Staff December 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2018-D-4267
- Issued by:
-
Guidance Issuing OfficeCenter 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Biomarker Qualification: Evidentiary Framework.” This draft guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act (Cures Act),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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