For Industry

Electronic Submissions Gateway

Background and Project Status

The 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 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. <more...>

 

For ESG Related Questions
Email: ESGHelpDesk@fda.hhs.gov  

ESG has consolidated the help desk functions under ESGHelpDesk@fda.hhs.gov. All ESG related issues should be addressed to ESGHelpDesk@fda.hhs.gov. Addressing ESG related questions/issues to an individual or other email addresses will cause delays in response time as the request will have to be re-routed to ESGHelpDesk@fda.hhs.gov. Please submit all future requests to ESGHelpDesk@fda.hhs.gov.

 

WebTrader Hosted Solution (WTHS)

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) would like to notify users utilizing the WebTrader for FDA submissions of the WebTrader Hosted Solution (WTHS). For more information on WebTrader Hosted Solution, please visit: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm397489.htm

Page Last Updated: 05/04/2015
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