Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Anti-Infective Drug Products for the Pediatric Population." The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help facilitate pediatric anti-infective drug product development. This guidance finalizes the draft guidance of the same title issued on June 30, 2020.