Ulcerative Colitis: Developing Drugs for Treatment
April 29, 2022
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.
FDA Released Draft Guidance on Common Issues in Rare Disease Drug Development
After the FDA passed the Orphan Drug Act in 1983, the number of orphan drugs (drugs indicated for the treatment of rare diseases that affect 200,000 people or less in the United States) submitted to...