May 3, 2018
On May 23, 2018, the Center for Veterinary Medicine (CVM) will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process which was announced on April 3, 2018.
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).
CVM’s Office of New Animal Drug Evaluation (ONADE) is hosting this webinar to address the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS) registration processes.
The webinar will be live-cast and a recording will be available on the FDA website shortly after the presentation date. Registration prior to the webinar is not required. The webinar will be open to the first 500 participants.
Webinar 1: FDA ESG and CVM ESS Registration Process
Wednesday May 23, 2018: Time: 9 - 11 AM EDST
CVM encourages everyone to test your computer well in advance of the webinar. Please visit: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
To access the webinar, use the following link: https://collaboration.fda.gov/cvmesubwebinar1/
- Introductions/Agenda: 9:00 – 9:05 am
- Overview of Electronic Submission Process: 9:05 – 9:20 am
- FDA ESG Registration: 9:20 – 9:50 am
- Question and Answer: 9:50 – 10:05 am
- CVM ESS Registration: 10:05 – 10:35 am
- Question and Answer: 10:35 – 10:50 am
- Closing Remarks: 10:50 – 10:55 am
For information about submitting electronically to CVM, please see our Electronic Submissions webpage.
To download eSubmitter, visit our CVM eSubmitter Program webpage.
If you have any questions regarding electronic submissions, email CVM’s Electronic Submissions Support Team at firstname.lastname@example.org.
For questions, Contact CVM.