U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
FDA eCTD Overview and Submission WBT
Transmitting Electronic Submissions to CDER
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WebTrader

Prior to using the ESG, a WebTrader account has to be created by the small business owner. You should refer to the Setting up a WebTrader Account Checklist Web site, which you can access under the Resources tab. On the Web site is a checklist to help you with the setup of an ESG account.

What is WebTrader? WebTrader is an applet that is downloaded on to your PC, when you log on to the FDA ESG Web page. It is part of the Axway COTS product suite that is used at FDA.

WebTrader is a Web interface that copies and packages your submission on your desktop in a secure fashion, transmits the submission in a fully encrypted message to the FDA, and then removes any traces of its presence from your PC.

For policy questions and to request a WebTrader account, contact esgprep@fda.hhs.gov.

For assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov.

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