Animal & Veterinary

CVM releases eSubmitter Webinar Series

April 3, 2018

Beginning on May 23, 2018, the Center for Veterinary Medicine (CVM) will host a three-part webinar series to provide information on the new animal drug application approval process. CVM’s Office of New Animal Drug Evaluation (ONADE) is hosting 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.

Since the release of eSubmitter in March 2011, the number of electronic submissions has increased. The purpose of these webinars is to support the use of eSubmitter in the new animal drug application approval process as we move to 100% electronic submission on October 1, 2018, with the anticipated reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). Each webinar listed below will be live-cast and recordings will be available on FDA.gov shortly after the presentation date.

Webinar 1: FDA ESG and CVM ESS Registration Process
Wednesday May 23, 2018: Time: 9 - 11 AM EDST

Specific topics to be discussed:

  • Overview of electronic submission process
  • How to complete registration with FDA ESG
  • How to complete registration with CVM ESS
  • Types of connections (AS2 v. Webtrader)
  • Webtrader basics

Webinar 2: How to Use the eSubmitter Tool
Wednesday August 22, 2018: Time: 9 AM – 12 PM and 1 PM – 4 PM EDST

Specific topics to be discussed:
Morning Session:

  • Downloading and installing CVM eSubmitter
  • Launching eSubmitter and basic navigation
  • Creating a new submission
  • Finalizing and packaging a submission
  • Submitting to CVM and viewing CVM Reponses

Afternoon Breakout Sessions will focus on building specific submission types.

Webinar 3: Follow-up Question and Answer Session
Wednesday September 19, 2018: Time: 9 – 11 AM EDST

Detailed agendas will be published prior to each webinar.

For information about submitting electronically to CVM, please see the webpage: https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSubmissions/default.htm.

To download eSubmitter, visit: https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm226814.htm.

If you have any questions regarding electronic submissions, email CVM’s Electronic Submissions Support Team at cvmesubmitter@fda.hhs.gov.

 

Contact FDA

240-402-7002
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7500 Standish Place, HFV-1

Rockville, MD 20855

Page Last Updated: 04/03/2018
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