S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals International Council for Harmonisation; Draft Guidance for Industry May 2021
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety assessments to support the development of pharmaceuticals intended for pediatric use. Harmonisation of the guidance for nonclinical safety studies will define the current recommendations and reduce the likelihood that substantial differences will exist among regions. It should facilitate the timely conduct of pediatric clinical trials and reduce the use of animals in accordance with the 3R (replace/reduce/refine) principles.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-4524.