The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

CBER Hacked; Drugmaker Account Information May Be Compromised

Nov. 22, 2013
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The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen.

The agency says it detected an unauthorized network access on Oct. 15 during the government shutdown, and discovered hackers were able to obtain user account information.

On Oct. 18, the agency emailed account holders about the hack and asked users to reset their passwords. In addition, it says users may need to take additional precautions. If CBER users employ their FDA password on other websites, the agency advises them to change those passwords and monitor those sites for unauthorized activities. If this includes financial accounts, users should consider placing a fraud alert on related accounts.

On Nov. 8, the agency quietly made the issue public by posting a message about the hack on the CBER submission site that states information for certain users including their first and last names, phone numbers, email addresses, usernames and passwords had been compromised, and they should take measures to protect their online identity.

The CBER site is used to submit information on biological product deviations, blood establishment registrations and tissue establishment registrations. So far, the agency says no system data has been altered, but it is also still analyzing whether there were any unauthorized logins to the system.

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