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

Lab technician looking at a computer monitor with in a labratory.
FDA

May 4, 2022

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability

May 2022 Guidance Document Download the Final Guidance Document The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of...

Continue reading the blog post
Specialty drug development project management scheduling concepts with ProPharma's flywheel overlaid
Program & Project Management

May 29, 2023

Key Challenges of Specialty Pharma Drug Development Project Management

Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...

Continue reading the blog post
'Risk management' is illuminated by light emitting from a tablet device.
FDA

May 20, 2022

FDA Draft Guidance: Risk Management Plans to Mitigate the Potential for Drug Shortages

Industry Draft Guidance Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s...

Continue reading the blog post