FDA Publishes Guidance for Developing Gastroesophageal Reflux Treatments in Children
The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics.
The draft guidance recommends discussing study designs with the FDA as early as possible, and on a case-by-case basis. Sponsors are required by law to submit pediatric study plans no later than 60 days following an end-of-Phase-II meeting in the development of a drug for an adult population.
Sponsors should at least address the entire pediatric age range, from birth through 16 years old.