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FDA ESG (also searched as “ESG FDA”) is the FDA’s Electronic Submissions Gateway, the secure entry point through which regulated companies send electronic regulatory submissions to the agency. The current platform is ESG NextGen. This page explains what the gateway does and does not do, the three ways to connect to it, and where to find the official guides, as listed on FDA’s pages when read on 2026-11-08.
What is the FDA ESG?
The FDA Electronic Submissions Gateway Next Generation (ESG NextGen) is, in FDA’s words, “the FDA’s modernized platform for securely receiving and processing electronic regulatory submissions.” FDA describes it as a single entry point for the secure submission, receipt, acknowledgment, routing and notification of regulatory submissions. Its Unified Submission Portal replaces the legacy WebTrader user interface.
The most useful point for a first-time submitter is what the gateway is not. FDA states that ESG NextGen “itself does not open or review submissions”: it is a conduit. Each submission is routed automatically to the appropriate FDA Center or Office based on the selections the submitter makes during the submission process. A successful transmission therefore shows that the file reached FDA’s systems and was routed, not that any Center has assessed its content.
Who runs it and what it covers
ESG NextGen is operated by the U.S. Food and Drug Administration and is used for submissions to its Centers and Offices. The content itself is defined elsewhere, for example by the eCTD format for applications (see eCTD structure for clinical submissions), by Structured Product Labeling for labeling files (see Structured Product Labeling), and by the application type itself, such as an IND or an NDA. Which submission types each Center accepts through the gateway, and whether test submissions are required, is listed on FDA’s “Center Submission Types” page, which should be checked before any filing.
How do you access it? Three channels
FDA offers three access methods. Choose by how your organization produces and tracks submissions.
| Channel | What FDA says it is | Official guide (as listed 2026-11-08) |
|---|---|---|
| Unified Submission Portal (USP) | A web-based platform that replaces the legacy WebTrader interface; submit regulatory information and track status through Center receipt. | USP User Guide v1.8 (September 2026); USP Passkey Set-Up Quick Guide; training videos |
| API | Programmatic submission that lets an organization integrate submission into its own systems, with real-time status tracking through Center receipt. | API User Guide v1.2.1 (August 2026); API Specification v1.2 (March 2026) |
| Applicability Statement 2 (AS2) | A system-to-system connection for automated data exchange between FDA and its partners. FDA states that legacy ESG AS2 account users continue to be supported. | AS2 User Guide v2.2 (July 2026) |
Guide versions change, so confirm the current version on FDA’s ESG NextGen user guides page rather than relying on the numbers above.
How to get started
- Open FDA’s ESG NextGen page and go to the “Getting Started with ESG NextGen” section, which holds the user guides and training videos.
- Decide the channel: USP for manual web submission, API for integration into internal systems, or AS2 for system-to-system exchange.
- Read the user guide for that channel before creating an account. The training videos on FDA’s page cover the USP only.
- If you are a contract research organization, U.S. agent or consultant submitting for a sponsor, use FDA’s separate page, “Steps for CROs, U.S. Agents, and Consultants to Create an ESG NextGen Account”; FDA also has pages on the Letter of Non-Repudiation Agreement and the Authorization Letter for agents.
- Check the “Center Submission Types” page for the Center you are submitting to, including whether a test submission is required.
- Submit through your chosen channel and watch for the confirmations described on FDA’s “Submission Acknowledgements” page.
The sign-in for USP is the “Industry USP Log In” link at the top of FDA’s ESG NextGen page. Support questions go to [email protected], or to FDA at 1-888-INFO-FDA (1-888-463-6332).
Strengths and limits
Strengths
- One entry point for submissions to several Centers, with routing driven by the submitter’s selections.
- Three channels, so a small sponsor can use the web portal while a larger one automates through the API or AS2.
- Status tracking through Center receipt in both the USP and the API.
Limits to plan for
- Inactive accounts are deactivated. FDA states that, in compliance with FDA security policy and NIST standards, ESG accounts are automatically deactivated after 60 days of inactivity, and asks users to log in within 60 days. A sponsor that files only occasionally should account for this well before a deadline.
- Transmission is not review. The gateway does not open or review submissions, so content questions are handled by the receiving Center, not the gateway.
- Agents follow a separate path. Organizations submitting on behalf of others need the agent-specific account steps and letters described above.
Related access terms: WebTrader and legacy AS2
Older documents and vendor material still refer to WebTrader, the legacy web interface. FDA states that the USP replaces it. AS2 users on the legacy ESG continue to be supported on ESG NextGen. The three FDA-documented channels above are the options FDA lists.
FAQ
What does ESG stand for at the FDA?
ESG stands for Electronic Submissions Gateway. The current version is called Electronic Submissions Gateway Next Generation (ESG NextGen).
Does the FDA ESG review my submission?
No. FDA states that ESG NextGen does not open or review submissions. It receives, acknowledges, routes and notifies; the relevant Center or Office reviews the content.
How do I log in to the ESG?
Use the “Industry USP Log In” link at the top of FDA’s ESG NextGen page. Account creation and sign-in steps are in the official USP User Guide.
Why was my ESG account deactivated?
FDA deactivates ESG accounts that have been inactive for 60 days. Contact [email protected] for help.
Is the ESG the same as WebTrader?
WebTrader was the legacy web interface. FDA states that the Unified Submission Portal replaces it within ESG NextGen.
Sources
- FDA, Electronic Submissions Gateway Next Generation (ESG NextGen), content current as of 2026-11-04, read 2026-11-08.
- FDA, ESG NextGen User Guides, read 2026-11-08.
- FDA, Getting Started with ESG NextGen, read 2026-11-08.
