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U.S. Department of Health and Human Services

For Industry

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CVM ONADE eSubmitter Program

The Center of Veterinary Medicine’s (CVM) Office of New Animal Drug Evaluation (ONADE) has completed the CVM eSubmitter Project and developed a tool that enables the animal drug industry to voluntarily submit Investigational New Animal Drug (INAD) file submissions as well as New Animal Drug Application (NADA) submissions electronically in compliance with the commitment made during the Animal Drug User Fee Act (ADUFA II) of 2008.

The eSubmitter tool development was expanded to include all submission types submitted to ONADE. Along with the INAD and NADA submissions, the tool permits the creation and submission of Generic Investigational New Animal Drug (JINAD) files, Abbreviated New Animal Drug Applications (ANADA), Veterinary Master Files (VMF), and General Correspondence (GC) files.

The tool was made available, for voluntary use by sponsors and manufacturers in the animal health industry, on March 11, 2011. The animal health industry may now use the eSubmitter for the creation of all of their official submissions to ONADE/CVM in lieu of paper.
 

CVM Workshop Information

An online, public workshop was held on October 21, 2010, to introduce the CVM Beta release of the eSubmitter tool.

Getting Started

The eSubmitter tool, with the CVM templates, is available to download NOW. If you already have eSubmitter installed, you only need to start eSubmitter (with your computer connected to the internet) and the CVM templates will download and install automatically.

A combined FAQ and Question & Answer document that captures common questions CVM has received is available here.

Questions?

For questions, please contact us at cvmesubmitter@fda.hhs.gov