Editing Food and Drug Administration (section)

===Electronic Submissions Gateway (ESG)===

To standardize, automate and streamline the flow of regulatory data, FDA introduced an Electronic Submissions Gateway (ESG) in 2006. This gateway allows reporting organizations to send regulatory submissions to different centers over the internet, packaged in a center-specific format and enveloped as a GNU-compatible .tar.gz file, through either a FDA-specific WebTrader application<ref>{{cite web |title=Setting up a WebTrader Account Checklist |url=https://www.fda.gov/industry/create-esg-account/setting-webtrader-account-checklist | publisher = U.S. Food and Drug Administ ration|date=May 12, 2023 }}</ref> or via a more generic B2B communication protocol called AS2 (Applicability Statement 2).<ref>{{cite web |title=AS2 Protocol |url=https://aayutechnologies.com/docs/as2/as2-protocol/ |website=Aayu Technologies}}</ref>

For WebTrader, which is recommended for manual, small-volume submissions, users would typically install a client application<ref>{{cite web |title=Food and Drug Administration |url=https://www.fda.gov/media/156910/download?attachment | publisher = U.S. Food and Drug Administ ration}}</ref> on their computers and upload the package through it to FDA server. In AS2, which is recommended for automated or high-volume submissions, users can use any standard AS2 software to transmit the package to FDA by including additional routing details on top of standard AS2, in the form of custom HTTP request headers.<ref>{{cite web |title=ESG Appendix F: AS2 Header Attributes |url=https://www.fda.gov/industry/about-esg/esg-appendix-f-as2-header-attributes | publisher = U.S. Food and Drug Administ ration|date=June 10, 2024 }}</ref>