Nonclinical Safety Evaluation of Pediatric Drug Products
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 2003D-0001.