FDA Launches Pilot Project for Electronic Submission of Margin of Safety and NonClinical Toxicology Study Data

Summary

The FDA's Center for Veterinary Medicine is seeking sponsors to participate in a pilot project to test the electronic submission of margin of safety and nonclinical toxicology study data using the Standard for Exchange of Nonclinical Data (SEND) format, with the goal of enabling electronic submission of related data for investigational new animal drug (INAD) files and new animal drug applications (NADA's).