FDA: Ulcerative Colitis: Clinical Trial Endpoints

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 This draft guidance is intended to serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Errors Products (DGIEP), pharmaceutical sponsors,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