FDA Releases Electronic Submission Tool, eSubmitter, for Use by the Animal Health Industry

March 11, 2011

The Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM) today released an electronic submission tool, eSubmitter, for use in submitting Investigational New Animal Drug (INAD) file submissions and New Animal Drug Application (NADA) submissions. Electronic submission will eliminate the need for paper, reduce printing and mailing costs for industry, and will allow CVM scientists to review the submissions electronically. eSubmitter provides a structured online system allowing for a more efficient and effective drug approval process than with paper submissions.

The development and release of eSubmitter meets one of the goals of the 2008 Animal Drug User Fee Act (ADUFA). ADUFA required the creation of a tool for INAD and NADA electronic submissions; however, CVM expanded the development to include all submission types. Along with the INAD and NADA submissions, the tool will permit 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.

For additional information or to download and install eSubmitter, please see: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm226814.htm.

For questions about CVM’s eSubmitter program, please email the CVM eSubmitter team at cvmesubmitter@fda.hhs.gov .