eSubmitter Tool Available March 11, 2011
The Food and Drug Administration's eSubmitter tool is part of an electronic submissions program for a variety of submission types. The tool was made available for voluntary use by sponsors, and manufacturers in the animal health industry on March 11, 2011, for submissions to the Office of New Animal Drug Evaluation (ONADE). With completion of ONADE's rollout, additional submission types from other offices within CVM (Office of Surveillance and Compliance and Office of Minor Use and Minor Species) will become available. The eSubmitter program is a free program that is designed to minimize redundant data entry while collecting data in a structured format.
Anyone transmitting electronic submissions to CVM must first register with the FDA Electronic Submissions Gateway and follow all requirements for setting up an account with the Gateway (FDA ESG). See the Electronic Submissions Gateway site to register as a trading partner. If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the ESG website.
Once you have established your FDA ESG account, you must register with CVM and follow the requirements in the Guidance for Industry #108 How to Submit Information in Electronic Format to CVM using the FDA Electronic Submission Gateway.