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U.S. Department of Health and Human Services

For Industry

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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...>

 

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 a new capability: the WebTrader Hosted Solution (WTHS). This new capability will be available starting June 1, 2014. For more information on WebTrader Hosted Solution, please visit: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm397489.htm

 

Help Desk

Preparation/Registration/Policy Questions
Email: esgprep@fda.hhs.gov

 

For Technical Issues with Submissions
Email: ESGHelpDesk@fda.hhs.gov  

If you have not received the Center (second) acknowledgement within 4 hours after the end of the transmission, contact ESGHelpDesk@fda.hhs.gov 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.

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