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Electronic Submissions Gateway

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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...>

Electronic Drug Registration and Listing Instructions
Click here to learn more about setting up an ESG account for the purpose of sending Registration of Drug Establishment/Labeler Code Assignment, Drug Product Listing, and Registered Establishments' Report of Private Label Distributors.

New or Updated Documents

The FDA ESG Pre-Production system was upgraded to Axway Interchange v5.5.2 on June 22, 2008. We attempted to upgrade the Production system on November 22-23, 2008. The upgrade failed. Plans for upgrading the Production system are on hold. WebTrader users will not have to upgrade their Java installations.

The following documents have been updated or added as a result of the upgrade in pre-production:

  • User Guide: HTML PDF
  • Troubleshooting JCE issues in WebTrader v5.5.2: PDF
  • Identifying and Fixing the WebTrader Cache Download Issue: HTML

New Features in v5.5.2:

The ESG Production and Pre-production Systems now support the use of AS2 Routing IDs. The use of unique AS2 Routing IDs to identify the type of submission and destination will only work for Transaction Partners using Cyclone/Axway gateway software. Version 5.5.2 of Axway Interchange will add support for the use of Routing IDs for other gateway systems. No implementation date for v5.5.2 has been set. Refer to Appendix K of the User Guide for more information about using AS2 Routing IDs with Axway software.

  • User Guide (last update October 13, 2008, 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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