federal_register: 2018-26900

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2018-26900 Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Biomarker Qualification: Evidentiary Framework." This draft guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act (Cures Act),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. 2018-12-12 2018 12 https://www.federalregister.gov/documents/2018/12/12/2018-26900/biomarker-qualification-evidentiary-framework-draft-guidance-for-industry-and-food-and-drug https://www.govinfo.gov/content/pkg/FR-2018-12-12/pdf/2018-26900.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Biomarker Qualification: Evidentiary Framework." This draft guidance provides recommendations on general...

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