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
On January 29, 2018, the Center for Veterinary Medicine (CVM) Office of Surveillance and Compliance (OSC) launched 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.
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.
Messages to Industry
- February 7, 2020 – ESS Registration Requirement for DER Digital Signatures
Need Help?
Email us at cvmesubmitter@fda.hhs.gov