A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic regulatory submissions, warns those using the WebTrader for electronic submissions to delete their inboxes, or risk losing all documents contained within them in the future. WebTrader is supposed to be a low-volume submission tool; however, some companies have apparently been using the system as a file server or archival system.

The FDA states that the misuse of the system has resulted in significantly lower performance for all other account holders. It suggests removing the submission records and storing them either locally or on a companywide network. The email also listed the number of “offending” accounts:
• 1 account has more than 3,000 documents
• 9 accounts have more than 2,000 documents
• 34 accounts have more than 1,000 documents
• 96 accounts have more than 500 documents
• 763 accounts have more than 100 documents
• 2,833 accounts have more than 20 documents

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