Issue Date: April 28, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Ulcerative Colitis: Developing Drugs for Treatment
The purpose of this guidance is to help sponsors in the clinical development of drugs to treat adults with ulcerative colitis (UC). This guidance addresses the Food and Drug Administration’s (FDA’s) current recommendations on clinical trials for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 351 of the Public Health Service Act (42 U.S.C. 262) and 21 CFR parts 312, 314, and 601 for treating UC. Specifically, this guidance addresses FDA’s current thinking about the necessary attributes of clinical trials for drugs being developed for treating UC, including trial population, trial designs, efficacy considerations, and safety assessments.
Download the Guidance Document
