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# Guide on Ulcerative Colitis Drugs
- URL: https://www.fdaweb.com/guide-on-ulcerative-colitis-drugs/
- Published: 2022-04-29T12:00:00.000Z
- Updated: 2026-09-14T17:42:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151712

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ulcerative-colitis-developing-drugs-treatment?ref=fdaweb.com) entitled *Ulcerative Colitis: Developing Drugs for Treatment*. The document addresses FDA’s current thinking on the necessary attributes of clinical trials for such drugs, including trial population, trial design, efficacy considerations, and safety assessments. The guidance does not address extraintestinal manifestations of ulcerative colitis (UC), pediatric drug development, or the treatment or prevention of long-term complications of UC (e.g., this guidance is not intended to discuss endpoints for prevention or reduction in risk of colorectal cancer).