FDA Releases Draft Industry Guidance on Crohn’s and Ulcerative Colitis Drug Development - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Releases Draft Industry Guidance on Crohn's and UC Drug Development  FDA 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 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   "Ulcerative Colitis:  Developing Drugs for Treatment" replaces the withdrawn 2016 draft guidance for industry, "Ulcerative Colitis: Clinical Trial Endpoints."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.   This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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