FDA Announces Key Transition Dates for ESG NexGen

Halloran  participated in the User Acceptance Testing last summer/fall and is excited about the release of this new platform to better serve clients’ submission needs.

To modernize the existing Electronic Submission Gateway (ESG), the FDA has developed a new interface with a cloud-based architecture. This platform incorporates an Identity and Access Management solution capable of supporting greater submission bandwidth and storage. The new platform is called ESG Next Generation (ESG NexGen).

The following are the key transition dates recently disclosed:

• March 28–30, 2025: Legacy ESG production data will be migrated to ESG NexGen.
• March 31 – April 9, 2025: Open period for users to conduct submission testing and validate/update data migrated from legacy ESG.
• April 12, 12:00 AM – April 14, 9:00 AM (EDT): Legacy ESG, including WebTrader and AS2 accounts, will be disabled.
• April 14, 2025, 9:00 AM (EDT): ESG NexGen goes live, and test and production submissions will be enabled.

Important: The FDA advises all users not to submit during the April 12–14 window.

ESG NexGen is designed to enhance the user experience with improved user-friendliness, real-time tracking, increased transparency, enhanced security with multi-factor authentication, and a new Application Programming Interface (API) that allows systems to connect directly.

To learn more about our author,  read Daniel Smith's bio.