Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment JULY 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pediatric-inflammatory-bowel-disease-developing-drugs-treatment?utm_medium=email&utm_source=govdelivery FDA issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric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). Specifically, this guidance provides the agency’s recommendations for clinical study attributes for pediatric ulcerative colitis or pediatric Crohn’s disease treatments, including: study design, study population, efficacy considerations, and safety assessments. This is the agency’s first guidance focused on clinical studies for pediatric IBD treatments. When finalized, this guidance will represent FDA’s current thinking on this topic. We encourage interested parties to submit comments by September 16, 2024, to ensure consideration before FDA begins work to finalize this guidance.