Electronic Submissions Gateway Next Generation (ESG NextGen)
Planned Outage
The Food and Drug Administration (FDA) will be conducting a scheduled maintenance of the Electronic Submissions Gateway Next Generation (ESG NextGen) platform, which will temporarily disrupt access to the system. This is a planned downtime to support system maintenance and upgrades, and users are advised to plan accordingly to avoid submission disruptions.
Scheduled Outage Details:
- Date: June 21, 2025
- Time: 2:00AM EST to 5:00AM EST
- Impact: During this time, the ESG NextGen will not be available for submissions. Any submissions that completed uploading just before the scheduled outage start time may receive delayed Acknowledgements.
We understand the importance of system availability and have scheduled this maintenance during the off-peak hours to minimize the impact and complete the maintenance as quickly as possible.
The ESG NextGen team will send a notification once the maintenance is complete.
Announcements
The Food and Drug Administration is excited to announce the Electronic Submission Gateway Next Generation (ESG NextGen) has been live since Monday April 14, 2025 and has been successfully receiving electronic submissions. The legacy Electronic Submission Gateway (ESG) has been retired and is no longer available for submissions.
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✉️