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

Regulatory NewsRegulatory News
| 22 January 2019 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance, developed by the International Council for Harmonisation (ICH), on the standards for nonclinical safety studies in the development of pediatric medicines.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


Factors informing the WoE evaluation include clinical information, pharmacological properties, pharmacokinetic data, nonclinical safety data and feasibility.

And if a juvenile animal study is found to be warranted, the guidance features a section on recommendations on study design considerations, core endpoints to be included in all studies and additional endpoints that can be included to address specific concerns.

Since the guidance was not posted to the Federal Register because of the shutdown, FDA is pointing all commenters to the ICH’s Secretariat email at step2comments@ich.org.

Further Guidance Release?

The release of the ICH guidance also comes as Gottlieb is cautioning about the release of future guidances, as they are supported by carryover user fees.

“These were guidance documents that, generally, were in very advanced stages of development, and close to being releasing before the lapse in appropriations. It's the case that new guidance development is being affected by the lapse,” he added.

S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines Core Guideline


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