USA – FDA Offers ICH S11 Guidance for Comment as Shutdown Threatens Further Guidance

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance, developed by the International Council for Harmonisation (ICH), on the standards for nonclinical safety studies in the development of pediatric medicines.

The 38-page guidance should be consulted for study design, and early consultation is recommended for consideration of nonclinical support for pediatric medicine development. The guideline lays out advice on determining the need for additional nonclinical safety investigations, designing nonclinical juvenile animal studies and other considerations related to pediatric-first or pediatric-only development.

“This guidance is intended to outline proper use of and design of animal toxicity studies, and potentially to reduce the use of animals in research conducted in support of pediatric clinical trials,” FDA Commissioner Scott Gottlieb said.

The guidance describes how a “Weight of Evidence” (WoE) approach can help drug developers as it “considers multiple factors evaluated together and, therefore a single factor should not be considered in isolation. The importance of each factor should be weighted such that the final decision concludes whether available data adequately address safety concerns in the proposed paediatric population or whether additional nonclinical studies are warranted.”..