What is ESG?
FDA ESG provides two methods, WebTrader and AS2, for making submissions to FDA
- WebTrader: WebTrader is a web-based interface used to send documents and receive receipts and acknowledgments from the FDA. The WebTrader application makes communication with the FDA simple, cost-effective, and time-independent. WebTrader requires each user from an Industry Partner to register for their own unique WebTrader account. To see the steps needed to setup a WebTrader account please click here.
- AS2 (System-to-System): Industry Partners have the option to access the Gateway via system-to-system communication. System-to-system communication (often referred to as an AS2 Account) provides an automated connection to the FDA for submissions, receipts and acknowledgments. The system-to-system communication requires server(s) and software procurement and configuration from Industry Partners. System-to-system communication requires one user from an organization to register for the organizational account. Submissions can be sent automatically or manually and receipts and acknowledgments may be received asynchronously or synchronously. To see the steps needed to setup an AS2 account please click here.
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