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 This draft guidance is intended to serve as a focus for continued 22 discussions among the Division of Gastroenterology and Inborn Errors Products (DGIEP), 23 pharmaceutical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