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  1. FDA eSubmitter

CVM eSubmitter Program

The CVM Only Version of eSubmitter is now available for download!

The CVM eSubmitter tool is an electronic, question-based submission tool for creating information to be transmitted electronically to FDA through its secure Electronic Submission Gateway (ESG). eSubmitter uses data-capturing templates to allow users to assemble a complete and appropriately structured submission to CVM. The templates, available for all submission types varying from simple to complex, were developed by CVM subject-matter experts. The tool was originally developed on March 11, 2011, for submissions to the Office of New Animal Drug Evaluation (ONADE). Since the initial release of the ONADE Program, CVM's eSubmitter has been expanded to include the OMUMs Indexing Program, OSC Drug Experience Report Program, and the OSC Division of Animal Feeds Program. The eSubmitter program is a free program that is designed to minimize redundant data entry while collecting data in a structured format. In August 2017 CVM released their own version of the eSubmitter tool. The new version provides stakeholders and CVM with the following benefits:

  • Greater agility and responsiveness to CVM stakeholder feedback on templates and tool bug fixes and enhancements.
  • Singular focus on CVM stakeholder-specific submission needs.
  • Enhanced ability for CVM to meet user fee goals.
  • Further integration of submission technology with other CVM-internal IT systems.

Download CVM eSubmitter Here!

eSubmitter Webinar Series

The Center for Veterinary Medicine (CVM) hosted a three-part webinar series in 2018 to provide information on the new animal drug application approval process. CVM’s Office of New Animal Drug Evaluation (ONADE) hosted this webinar series to address the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS) registration processes as well as to provide information on how to use the eSubmitter tool. Webinar Agendas, recordings, and meeting materials are available on the CVM eSubmitter Resource Center page.

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