US FDA’s vet unit invites companies to test esubmission data standard
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration’s veterinary medicines unit is inviting companies to participate in a three-year pilot to test the electronic submission of margin of safety and nonclinical toxicology study data using the Standard for Exchange of Nonclinical Data (SEND), a new electronic data standard format which is used to support review activity1.
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