For Industry

Electronic Submissions Gateway

ESG Overview

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review.

The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office.

What's New

Attention WebTrader submitters!

 

The FDA ESG program is implementing a policy to automatically log a user out from the WebTrader user interface after 30 minutes of inactivity. This policy is being implemented to enhance the security posture of FDA ESG.  Please note that this change will not affect the functionality of the WebTrader in any way.

 

Production implementation date: March 2, 2019

 

FAQs:

 

Q1:        Will this session timeout delay submission or receipts or acknowledgements?

A1:        No. Processing of submissions, receipts, and acknowledgements will continue to work in the same way as today.

 

Q2:        What happens if I am uploading a very large submission that will take longer than 30 minutes?

A2:       The submission will continue to upload even after you are logged out of the user interface. Submission upload is handled by background process/service, not by the user interface.

 

For any questions/concerns relating to the WebTrader inbox purge policy, please contact ESGHelpDesk@fda.hhs.gov.

Contact Us

For ESG Related Questions
Email: ESGHelpDesk@fda.hhs.gov

 

Page Last Updated: 02/25/2019
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