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.

TAGS: FDA North America Ulcerative Colitis Agency Alerts Regulatory Sciences

Related Articles

Hand holding a sign saying 'guidance.'
FDA

August 22, 2022

FDA Issues Revised Draft Guidance on Charging for Investigational Drugs Under an Investigational New Drug Application

August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on...

Continue reading the blog post
Circle with 'assess risk', 'control risk', 'review control', and 'identify risk' written encircling the 'risk management process.'
FDA

June 15, 2022

Q9(R1) Quality Risk Management

Guidance Document June 2022 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any...

Continue reading the blog post
Lab technician looking at a sample.
FDA

June 24, 2022

FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation

Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation. This draft guidance...

Continue reading the blog post