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New ICH Guide To Eliminate ‘Discordant Advice’ On Juvenile Animal Studies

Executive Summary

Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline that explains in which situations nonclinical juvenile animal testing is considered informative and necessary to support pediatric drug development. The guideline is expected to address the "discordant advice" that different regulatory agencies currently offer companies in relation to such studies.

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