Back to all Thought Leadership

Ulcerative Colitis: Developing Drugs for Treatment

April 29, 2022

Guidance Document

April 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.

Download the Final Guidance Document

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.
FDA North America Ulcerative Colitis Agency Alerts Regulatory Sciences



Related Articles

Agency Alerts General Regulatory

August 20, 2015

FDA Released Draft Guidance on Common Issues in Rare Disease Drug Development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...

Read the Full Article
Agency Alerts General Regulatory

October 1, 2015

Will FDA Change the Definition of “Intended Use”?

FDA released proposed regulation that would allow sponsors to determine if their product is a drug/device, or if it is not a drug/device. Last week, the Agency announced a proposed rule “to provide...

Read the Full Article
General Regulatory Regulatory Sciences

March 31, 2015

Drug Development Questions And The FDA - The End Of The Black Hole

Commonly during drug development, significant issues arise for which FDA input is desired but that do not merit a full face-to-face multidisciplinary milestone meeting. In many cases, sponsors are...

Read the Full Article