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

These guidances provide an overview of FDA's current recommendations on the design of clinical trials evaluating the efficacy and safety of

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Releases Draft Industry Guidance on Crohn's and Ulcerative Colitis 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 "Ulcerative Colitis:  Developing Drugs for Treatment" replaces the withdrawn 2016 draft guidance for industry, "Ulcerative Colitis: Clinical Trial Endpoints."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.   The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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