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# Crohn’s Disease Draft Guidance Released
- URL: https://www.fdaweb.com/crohns-disease-draft-guidance-released/
- Published: 2022-04-29T12:00:00.000Z
- Updated: 2026-09-14T17:42:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151707

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/crohns-disease-developing-drugs-treatment?ref=fdaweb.com) entitled *Crohn’s Disease: Developing Drugs for Treatment*. The document addresses the agency’s current recommendations on clinical trials for Crohn’s Disease (CD) drugs being developed, such as trial population, trial design, efficacy considerations, and safety assessments. FDA notes that the guidance does not address extraintestinal manifestations of CD, stricturing or fistulizing disease, pediatric drug development, or the treatment or prevention of long-term complications of CD.