Docket Number:
FDA-2016-D-2319
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the 19 treatment of ulcerative colitis (UC) in adult and pediatric patients. Specifically, this guidance 20 addresses the Food and Drug Administration’s (FDA’s) current thinking regarding efficacy 21 endpoints for UC clinical trials. This draft guidance is intended to serve as a focus for continued 22 discussions among the Division of Gastroenterology and Inborn Errors Products (DGIEP), 23 pharmaceutical sponsors, the academic community, and the public.

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All written comments should be identified with this document's docket number: FDA-2016-D-2319.