August 21, 2017
Authored and Edited by Jessica L.A. Marks; Linda A. Wadler
The FDA rolled out a new tool for preparing submissions to the Center for Veterinary Medicine in August 2017. This new tool is conveniently named the “CVM eSubmitter.” All electronically submitted documents for the CVM must be completed using the downloadable CVM eSubmitter tool, including all submissions to the Office of New Animal Drug Evaluation (e.g., NADA and ANADA submissions).
Before the separate CVM eSubmitter was launched, templates for electronic CVM documents were supported by the FDA’s general eSubmitter tool. The new CVM eSubmitter tool is focused solely on CVM stakeholder submission needs, which the FDA believes will allow the CVM to be more responsive.
The FDA has scheduled a six-month transition period for users to switch from the general eSubmitter tool to the CVM eSubmitter tool. Users may prepare new CVM submissions within either tool until December 1, 2017. From December 1, 2017 to March 1, 2018, users who started submissions may still use the general eSubmitter tool to complete those submissions, but all new submissions must be created in the CVM eSubmitter tool. After March 1, 2018, use of the general eSubmitter tool for CVM submissions will be discontinued, and all electronic submissions will need to be prepared using the CVM eSubmitter tool.
Food and Drug Administration (FDA), New Animal Drug Application (NADA), veterinary pharmaceuticals
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