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# Guidance on Pediatric IBD Drug Development
- URL: https://www.fdaweb.com/guidance-on-pediatric-ibd-drug-development/
- Published: 2024-07-16T12:00:00.000Z
- Updated: 2026-09-14T14:35:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157359

FDA has published a draft guidance, *Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment*, to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease (IBD). The [document](https://www.fda.gov/media/180126/download?ref=fdaweb.com) says the draft specifically provides agency recommendations about the necessary attributes of clinical studies for drugs being developed for the treatment of pediatric ulcerative colitis or pediatric Crohn’s disease, including study population, study design, efficacy considerations, and safety assessments.

The guidance says it does not address extraintestinal manifestations, structuring or fistulizing disease, or the treatment or prevention of long-term complications of pediatric ulcerative colitis or Crohn’s disease. It also is not intended to address treating monogenic IBD or IBD unclassified.

“The recommendations for clinical study design in this guidance are based upon the assumption that a robust development program is being conducted in adults and that efficacy data from adults will be available to help inform the pediatric program and to support extrapolation of efficacy,” FDA says. “Sponsors seeking to develop a drug only for pediatric ulcerative colitis or Crohn’s disease patients in the absence of an adult program should meet with the appropriate review division to discuss their proposals.”