BRIEF—FDA draft guidance on pediatric IBD treatment development

The US Food and Drug Administration (FDA) issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric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;