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Electronic Submissions Gateway Next Generation (ESG NextGen)

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Announcement: Scheduled Standard Release on January 30, 2026

The FDA Electronic Submission Gateway Next Generation (ESG NextGen) system will undergo a scheduled release on January 30, 2026, 10:00 PM ET through January 31, 2026, 5:00 AM ET. During this time, the system will be unavailable. Users are advised to plan accordingly to avoid submission disruptions.

RELEASE SCHEDULE & IMPACT:

  • Start Date & Time: Friday, January 30, 2026, 10:00 PM ET
  • End Date & Time: Saturday, January 31, 2026, 5:00 AM ET
  • Scope: Unified Submission Portal (USP), AS2 submissions, API submissions
  • Impact: During the release period, ESG NextGen will not be accessible. Any submissions which completed uploading just before the scheduled start time may receive delayed Acknowledgements.

 

RELEASE DETAILS:
Updated

  • US State will be required for new USP registrations for addresses within the US.
  • In User Management, the Non-Repudiation Letter grid will display the name of the user an individual Non-Repudiation Letter is for. Company-wide Non-Repudiation Letters will display N/A. (This functionality is available to Power Users.)
  • Middle name is no longer displayed within the USP.
  • Resolved issue where company name was not displaying in the company dropdown during registration.
  • Resolved issue where multiple ACK failure messages were being sent out.

Announcement: Legacy ESG Cert Update

The US Department of Health and Human Services cert referenced below, which is set to expire on December 26, 2025, has not been in use since ESG NextGen went live earlier in 2025. The cert expiring on December 26, 2025, does not need to be renewed to continue to use ESG NextGen.

Cert Information which is not needing to be renewed:

  • Valid From: Tuesday, November 26, 2024
  • Valid To: Friday, December 26, 2025
  • URL: esg.fda.gov

For any active certs utilized by ESG NextGen, the ESG NextGen team will provide the industry new cert information prior to the certs expiration date. Note the ESG NextGen team does not recommend pinning SSL certificates to limit the impact of the expiration of the SSL certificate.

Announcement: USP Google Chrome and Microsoft Edge USERS - ESG NextGen Update

ESG NextGen Unified Submission Portal (USP) users utilizing Google Chrome v142 (or newer) or Microsoft Edge v143 (or newer) will experience a modified workflow when access FileCatalyst TransferAgent. Any users accessing ESG NextGen USP on Google Chrome version 142 (or newer) or Microsoft Edge v143 (or newer) will be prompted to open the FileCatalyst TransferAgent in a new tab or window in order to begin the upload.

The ESG NextGen team is working with the appropriate vendor so the original FileCatalyst TransferAgent workflow can be restored.

Please review the FileCatalyst TransferAgent modified workflow guide for further instructions.

Getting Started with ESG NextGen

The Getting Started with ESG NextGen section provides users with the tools needed to start utilizing ESG NextGen. User guides and training videos are available within this section. 

To log in, use the ‘Industry USP Login’ link above to get started in the Unified Submission Portal (USP). In compliance with FDA security policy and NIST standards, ESG accounts will automatically be deactivated if inactive for 60 days. Please log in within 60 days to avoid deactivation. 

What is ESG NextGen? 

The Food and Drug Administration (FDA) Electronic Submissions Gateway Next Generation (ESG NextGen) is the FDA’s modernized platform for securely receiving and processing electronic regulatory submissions with improved architecture that supports greatly expanding submission bandwidth and storage. ESG NextGen provides a high-performance gateway for FDA and its global partners, allowing the seamless submission of regulatory documents and enabling the FDA to streamline review processes. ESG NextGen functions as a unified solution, serving as a single-entry point for the secure submission, receipt, acknowledgment, routing, and notification of all regulatory submissions to the FDA. 

  • Unified Submission Portal (USP): The ESG NextGen USP is a user-friendly web-based platform which replaces the legacy WebTrader user interface. The USP provides the ability to submit regulatory information to the FDA and track the status through Center receipt. 
  • API Integration: ESG NextGen’s suite of APIs enables programmatic submissions, allowing organizations to integrate submission processes directly into their internal systems. This option supports the automation of submission workflows and real-time status tracking through Center receipt of the submission. 
  • Applicability Statement 2 (AS2): A system-to-system connection for an automated data exchange between the FDA and its partners. 

Where Do Submissions Go? 

ESG NextGen acts as a secure conduit for all electronic submissions to the FDA. Each submission is automatically routed to the appropriate FDA Center or Office based on user selections chosen during the submission process. ESG NextGen itself does not open or review submissions but serves as a secure and efficient channel for ensuring regulatory information reaches its destination. 

Contact Us 

For ESG NextGen related questions: ESGNGSupport@fda.hhs.gov✉️



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