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GUIDANCE DOCUMENT

Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment July 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2682
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.” The draft guidance was prepared by the Division of Gastroenterology in the Center for Drug Evaluation and Research at FDA to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease. The draft guidance provides FDA’s recommendations about the necessary attributes of clinical studies for drugs being developed for the treatment of pediatric ulcerative colitis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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2682.

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