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# Draft ICH Nonclinical Safety Test Guidance
- URL: https://www.fdaweb.com/draft-ich-nonclinical-safety-test-guidance/
- Published: 2019-01-22T12:00:00.000Z
- Updated: 2026-09-15T00:55:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143193

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, and promoting harmonization of, the 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. Tissue engineered products, gene and cellular therapies, and vaccines are excluded from the guideline’s scope.