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# Guide on Pediatric Nonclinical Drug Safety Testing
- URL: https://www.fdaweb.com/guide-on-pediatric-nonclinical-drug-safety-testing/
- Published: 2019-02-04T12:00:00.000Z
- Updated: 2026-09-15T01:00:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143290

*Federal Register* notice: FDA has released a draft International Council for Harmonization guidance, *S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines*, recommending international standards for nonclinical safety studies recommended to support development of pediatric medicines. The [document](ttps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629683.pdf) recommends an approach for the nonclinical safety evaluation of medicines intended for development in pediatric populations. It says this can include products with prior adult use, as well as products being considered for initial human use in pediatrics. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-01/pdf/2019-00681.pdf?ref=fdaweb.com).