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Responses to the Standard for Exchange of Nonclinical Data (SEND) in Non-US Countries
Authors: Takayuki Anzai, Masamichi Kaminishi, Keizo Sato, Laura Kaufman, Hijiri Iwata, and Dai Nakae
Published: March 31, 2015
Location: Journal of Toxicologic Pathology
In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs need a model for task allocation. This is being undertaken by the pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved.