FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now use this updated system instead of the retired WebTrader platform.
The launch marks a major infrastructure upgrade. With improved file handling, automated submission tracking, and strengthened cybersecurity, ESG NextGen is designed to reduce submission errors, improve visibility, and support a more efficient regulatory process.
Keep reading to find out how to register, what’s new, and how you can prepare your team.
What is FDA ESG NextGen?
FDA ESG NextGen is the modernized version of the Electronic Submission Gateway (ESG). Developed under the Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act (BsUFA) commitments, the platform was created to resolve performance issues with the older system and support high-volume, complex submissions across industry sectors.
If your company regularly interacts with the FDA through structured electronic submissions, ESG NextGen is now your official point of access.
Benefits of the new ESG NextGen system
Here’s what makes this new platform easier and more efficient for you:
- User-friendly portal: The Unified Submission Portal (USP) has replaced WebTrader with a more intuitive design.
- Real-time tracking: You can check the status of your submission anytime.
- Stronger cybersecurity: With multi-factor authentication and better access control, your data stays protected.
- Automated workflows: The API feature allows your systems to connect directly and send updates automatically.
- Simplified requirements: You won’t need a signing certificate for USP submissions.
How to register and get started
To start using FDA ESG NextGen, visit the official FDA ESG NextGen registration page to log in or create your account.
During your first submission, you’ll be prompted to download the File Catalyst Transfer Agent. This tool helps speed up your file transfers and ensures secure delivery.
You can also review official training resources before getting started:
- Unified Submission Portal (USP)
- Applicability Statement 2 (AS2)
- Application Programming Interface (API)
- API Specification
- Training Videos | FDA
Daily drop-in support sessions
If you need help navigating the system, the FDA is offering live support. You can join daily drop-in sessions until April 25, 2025, at 1:00 PM ET via Microsoft Teams. Each session is open to the public but limited to 1,000 attendees, so be sure to join early to secure a spot.
- Meeting ID: 299 130 361 466
- Passcode: m7Rw6Fz9
- Join via the FDA portal
Common questions from businesses
If you’re getting ready to switch to FDA ESG NextGen, you likely have a few questions. Here are some of the most common ones that companies are asking as they transition to the new system:
Will WebTrader still work?
No. WebTrader has been retired as of April 14, 2025.
Do I need new software?
Yes. The system will prompt you to install the File Catalyst Transfer Agent when you begin.
Can I still use AS2?
Yes. AS2 remains supported and still requires a signing certificate.
Is a signing certificate needed for USP?
No. Signing certificates are no longer required for USP submissions.
Make your transition smooth
The launch of FDA ESG NextGen represents a shift in how companies manage regulatory communications with the FDA. Adapting quickly is essential to avoid submission delays and ensure continuity in product registration or compliance filings.
Need help registering or planning your next submission? Contact us today or fill out the form below to get a free consultation with one of our experts. Talk to a Quality Smart Solutions expert today and ensure your FDA compliance process is ready to go.
