For Industry

CVM OSC DER eSubmitter Program

eSubmitter is an electronic, question-based submission tool that helps users compile information and submit it to the FDA. eSubmitter uses templates to collect data and walk users through the process of creating a complete and structured Drug Experience Report submission to FDA. The templates (available for all submission types, from simple to complex) were developed by CVM subject matter experts.

Launch of the CVM OSC Drug Experience Report (DER) eSubmitter Program

The Center for Veterinary Medicine (CVM) Office of Surveillance and Compliance (OSC) has developed the option to submit both “Transmittal of Periodic Reports and Promotional Material New Animal Drugs” (Form FDA 2301) and “Antimicrobial Animal Drug Distribution Report” (Form FDA 3744) electronically using eSubmitter.

As of January 29, 2018, CVM OSC Division of Surveillance is ready to receive and process electronic DER submissions. For additional information about how to use eSubmitter to send DER submissions to CVM, please refer to the CVM eSubmitter web page.

The templates for “Transmittal of Periodic Reports and Promotional Material New Animal Drugs” (Form FDA 2301) and “Antimicrobial Animal Drug Distribution Report” (Form FDA 3744) are available under “OSC DER SUBMISSIONS” in the CVM eSubmitter tool.

Need Help?

Email us at cvmesubmitter@fda.hhs.gov
 

Page Last Updated: 01/29/2018
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