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GUIDANCE DOCUMENT

Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry August 2016

Draft

Not for implementation. Contains non-binding recommendations.

Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry

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 This draft guidance is intended to serve as a focus for continued 22 discussions among the Division of Gastroenterology and Inborn Errors Products (DGIEP), 23 pharmaceutical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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.