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# Nonclinical Safety Testing Guide for Pediatric Drugs
- URL: https://www.fdaweb.com/nonclinical-safety-testing-guide-for-pediatric-drugs/
- Published: 2021-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:58:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149304

*Federal Register* notice: FDA has made available a final guidance entitled *S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals*. The document provides a “weight of evidence” approach to determine when nonclinical toxicity studies may be recommended in juvenile animals. If such studies are recommended, the guidance provides appropriate study designs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-05-12/pdf/2021-09964.pdf?ref=fdaweb.com).