New FDA Electronic Submission Gateway in Production Environment

The FDA ESG Production system is now available for submissions. It requires users to install a new WebTrader client that will no longer be Java dependent. This release upgrades existing hardware, allowing users to increase uptime and queue multiple submissions. 

By ASPHALION

Since September 18th Production FDA ESG 2nd generation is live


The FDA ESG Production system is now available for submissions. It requires users to install a new WebTrader client that will no longer be Java dependent. This release upgrades existing hardware, allowing users to increase uptime and queue multiple submissions. Additionally, browser compatibility is extended to IE 11, Firefox, and Chrome and it is possible to access files, receipts and acknowledgements from PC, Mac, tablet, smartphone,...


Note that after the upgrade you may experience some problems. FDA ESG has reported certificate and password issues from users:"Certificate: Some submissions are receiving certificate related errors after upload. If you receive a certificate error, please do not resend the submission. ESG will correct the certificate and reprocess the submission.Password: If the system prompts you to change the password, please update it and log in with the new password."


ASPHALION has extensive experience in transmitting electronic submissions using eCTD specifications. We can support you with setting up your ESG account as well as managing your FDA submissions. If you have any questions, please contact us: fda@asphalion.com

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