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U.S. Department of Health and Human Services

For Industry

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Electronic Submissions Gateway

“ESG is not able to accept VeriSign/Symantec certificates that have been issues after December 20, 2012. Symantec has changed the way they issue certificates on this date rendering them unusable with ESG. If you have a VeriSign certificate that was obtained before 12/20/2012 it will continue to work. We recommend that you obtain a certificate from another vendor if you are a new user or an existing user trying to renew your VeriSign certificate”

Background and Project Status

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 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 their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office. <more...>


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Help Desk

Preparation/Registration/Policy Questions
Email: esgprep@fda.hhs.gov


For Technical Issues with Submissions
Email: esgreg@gnsi.com

If you have not received the Center (second) acknowledgement within 4 hours after the end of the transmission, contact esgreg@gnsi.com for assistance. Please provide the message ID for the submission, the Company name on the account, and the date and time the submission was sent.