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BIO Comments on FDA Draft Guidance on Biomarker Qualification: Evidentiary Framework

February 11, 2019

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Biomarker Qualification: Evidentiary Framework.

The guidance provides industry and FDA staff with recommendations on considerations to address when developing a biomarker qualification under the 21st Century Cures Act, which added a new section to the Federal Food, Drug and Cosmetic Act.

BIO recognizes FDA’s efforts to clarify the evidentiary standards for biomarker qualification but suggests the guidance should include timelines. BIO commends FDA for including language about the use of biomarkers in an individual drug development program (e.g., investigational new drug application, new drug application, or biologics license application submissions), but asks FDA to make note of areas where there may need to be flexibility, such as in the case of rare diseases where there are limited populations.

The comments also discuss qualification of a biomarker that already has an established, specific context of use (COU), a pilot program to engage external experts to support the review of biomarker qualification submissions, and FDA’s plans to share information about submissions.

Download Full Comments Below
BIO Letter Biomarker Qualification Draft Guidance FDA-2018-D-4267
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