BRIEF—FDA draft industry guidance on Crohn's and ulcerative colitis drug development

The US Food and Drug Administration has released two draft guidances for industry focused on the development of drugs to treat Crohn’s disease (CD) and ulcerative colitis (UC).

“ Crohn’s Disease: Developing Drugs for Treatment” and “ Ulcerative Colitis: Developing Drugs for Treatment” provide an overview of the FDA’s current recommendations on the design of clinical trials evaluating the efficacy and safety of therapies intended for the treatment of adults with CD and UC. Each guidance covers trial population, trial designs, efficacy considerations, and safety assessments.

“Ulcerative Colitis: Developing Drugs for Treatment” replaces the withdrawn 2016 draft guidance for industry, “Ulcerative Colitis: Clinical Trial Endpoints.”

Public comment for each will remain open until June 28, 2022.