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UpdatesThe FDA ESG has been upgraded to v5.4.2. The following documents have been updated or added to reflect the new Webtrader interface:
Additional Updates:
The ESG Production and Pre-production Systems now support the use of AS2 Routing IDs. The use of unique AS2 Routing IDs to identify the type of submission and destination will only work for Transaction Partners using Cyclone/Axway gateway software. Version 5.5.2 of Axway Interchange will add support for the use of Routing IDs for other gateway systems. No implementation date for v5.5.2 has been set. Refer to Appendix K of the User Guide for more information about AS2 Routing IDs. FDA ESG support for AS1 has ended as of March 1, 2008. |
Help DeskPreparation/Registration/Policy QuestionsEmail: esgprep@fda.hhs.gov For Technical Issues with SubmissionsEmail: esgreg@gnsi.com If you have not received the Center (second) acknowledgement within 4 hours after the end of the transmission, contact esgreg@gnsi.com for assistance. Please provide the message ID for the submission, the Company name on the account, and the date and time the submission was sent. |
Background and Project StatusThe Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a receiving Center or Office) of the delivery of an electronic submission. The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office. The FDA ESG will roll out in two phases: The FDA ESG was made available to regulated Industry during the evening of May 2, 2006. The FDA ESG supports the receipt of guidance compliant electronic regulatory submissions of up to 100GB in size to CBER, CDER, and CDRH. The FDA ESG also supports the receipt of AERS reports and AERS attachments. The FDA ESG replaces the ESTRI Gateway which shut down operations during the evening of May 2, 2006. The FDA ESG is accepting registration requests for new test accounts as described elsewhere on this page under "Registering to Use the ESG". Please read this section carefully before submitting your registration request. Companies planning to transmit regulatory submissions via the WebTrader option will be asked to send a .pdf or eCTD based test submission that is 7.5 GB in size. Based on pilot testing with Industry volunteers, FDA recommends that submissions greater than 15 GB and less than 25 GB in size be sent overnight starting at 5PM EST to ensure receipt by the targeted FDA Center during the next business day. The FDA has begun work on Phase 2 plans to expand ESG capabilities. These plans include receipt of electronic submissions targeted for the Center of Veterinary Medicine, Center for Food Safety and Nutrition, and the Office of Orphan Product Designations. The list of electronic regulatory submissions that can be received by the FDA ESG will be expanded as the FDA promulgates additional electronic submission guidance documents and extends this capability to new operational units within FDA. |
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