GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2024-D-2682
- Docket Number:
- FDA-2024-D-2682
- Issued by:
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.” The draft guidance was prepared by the Division of Gastroenterology in the Center for Drug Evaluation and Research at FDA to help sponsors in the clinical development of drugs to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 The draft guidance provides FDA’s recommendations about the necessary attributes of clinical studies for drugs being developed for the treatment of pediatric ulcerative colitis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.
