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Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry August 2016


Not for implementation. Contains non-binding recommendations.

Docket Number:
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 This draft guidance is intended to serve as a focus for continued 22 discussions among the Division of Gastroenterology and Inborn Errors Products (DGIEP), 23 pharmaceutical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.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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