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U.S. Department of Health and Human Services

For Industry

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Electronic Submissions Gateway


 

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...>

 

Issue with Sending Submissions That Contain a Single File Larger Than 2GB

Multi-file submissions (directory) made using WebTrader to the FDA ESG that contain a single file larger than 2GB will fail due to a bug in the ESG system. This is a known bug in the ESG system that causes the compression of a multi-file submission with a single file(s) larger than 2GB by WebTrader to fail. FDA is currently working with the software vendor to resolve the issue.

 

The work around for the issue is to manually compress the submission (submission directory) to a .tar.gz format and send the compressed submission to FDA. You should contact your IT department to get help on manual compression of submissions. At this time ESG is not able to provide support with manual compression of the submissions. Please note that this issue only affects WebTrader account and does not affect AS2 (system-to-system) accounts.

 

Please contact esgreg@gnsi.com if you have any questions/concerns regarding this issue.

 

New or Updated Documents

  • Troubleshooting JCE issues in WebTrader v5.5.2: HTML 
  • PDF

 

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.

 

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