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# Guidance on Ulcerative Colitis Trial Endpoints
- URL: https://www.fdaweb.com/guidance-on-ulcerative-colitis-trial-endpoints/
- Published: 2016-08-08T12:00:00.000Z
- Updated: 2026-09-14T21:22:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136442

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Ulcerative Colitis: Clinical Trial Endpoints*. It aims to assist sponsors in the clinical development of drugs for treating ulcerative colitis (UC) in adult and pediatric patients and addresses FDA’s current thinking on efficacy endpoints for UC clinical trials. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM515143.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-08/pdf/2016-18716.pdf?ref=fdaweb.com)