FDA ESG

Step 1: Request a WebTrader Test Account - FDA ESG

Mar 23, 2023

To request a WebTrader test account, send an e-mail to ESGHelpDesk@fda.hhs.gov and include the following information:

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Step 2: Order Client Digital Certificate - FDA ESG

Aug 13, 2024

Step 2: Order Client Digital Certificate

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Step 3: Download and Install the Certificate - FDA ESG

Oct 10, 2023

Download & Install Your Certificate - FDA ESG

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Step 4: Export Public Key - FDA ESG

Feb 19, 2024

Export Public Key Open Internet Explorer. Click on the gear icon in the top right-hand corner. Click Internet Options.​

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Step 5: Set Up a Test Account - FDA ESG

Mar 23, 2023

Setting Up a Test Account You will receive a reply to your request in Step 1 from the FDA containing a temporary UserID and Password for your WebTrader test account. Once you receive this e-mail you are ready to set up the test account. Be sure to have the following items available during this process: Company and Contact Information Your Public Key (.p7b) that you exported in Step 4.

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Step 6: Complete a Test Submission - FDA ESG

Mar 23, 2023

Complete a Test Submission Navigate to https://esgtest.fda.gov/ to launch the FDA ESG Web Trader.

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Common Errors - FDA ESG

Mar 23, 2023

This error may occur if the user incorrectly enters the pass phrase to their certificate. Be sure to remember the pass phrase to your certificate as this information is only known by the certificate owner...

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FDA Checklist & FAQs (PersonalSign)

Mar 23, 2023

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.

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Secure E-Mail - FDA

Mar 23, 2023

The FDA uses self-signed certificates so the process for this is slightly different than standard S/MIME with trusted certificates.

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Update Public Key - FDA ESG (Renewals & Reissues)

Feb 19, 2024

This article provides step-by-step instructions for updating the public key in your FDA ESG account. This is necessary if you reissued or renewed your Client Digital Certificate. If this is not the solution you are looking for, please search for your solution in the search bar above.

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