Issue Date: February 15, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): Pediatric Product Development, Pharmacology/Toxicology
Status: Final
Nonclinical Safety Evaluation of Pediatric Drug Products
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.
Download the Guidance Document
