Guidance for Industry on Nonclinical Safety Evaluation of Pediatric Drug Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nonclinical Safety Evaluation of Pediatric Drug Products." This document provides guidance on the role and timing of animal studies in the nonclinical safety evaluation of therapeutics intended for the treatment of pediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in pediatric patients and makes recommendations on nonclinical testing.