The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled Development of Anti-Infective Drug Products for the Pediatric Population. This guidance provides general recommendations on the development of anti-infective medicines for pediatric patients. The guidance addresses the timing of initiation of pediatric clinical studies, enrollment strategies, extrapolation of efficacy, and other considerations to help facilitate pediatric anti-infective drug product development.
It is important to conduct clinical studies of anti-infective drugs in the pediatric population to assess safety and to inform dosing and assessment of efficacy. There are specific challenges with pediatric drug development that do not always apply to drug development for adult populations.
Further comments and suggestions on this guidance is to be given by September 29th, 2020. For more information, please refer to the Guidance Document.