The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on clinical trial design.
Both UC and Crohn’s disease are chronic inflammatory bowel diseases. In the current guidance documents, issued on 29 April 2022, agency officials outline their thinking on clinical trial populations, trial designs, efficacy considerations, and safety assessments. The guidance for UC replaces a 2016 draft guidance on clinical trial endpoints that was later withdrawn (RELATED: Ulcerative Colitis Drugs: FDA Offers Draft Guidance on Clinical Development, Regulatory Focus 08 August 2016)…
