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S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines February 2019


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines.” The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance recommends international standards for the nonclinical safety studies recommended to support the development of pediatric medicines. Tissue engineered products, gene and cellular therapies, and vaccines are excluded from the scope of this guidance. The guidance 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. The draft guidance is intended to promote harmonization of recommendations for such studies and should facilitate the timely conduct of pediatric clinical trials and reduce the use of animals in accordance with the 3Rs (replace/reduce/refine) principles.

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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:

Dockets Management
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.

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