Letter to FDA Regarding Recent Cyber Security Breach

December 9, 2013

Excerpt: "According to information FDA provided to the media, on October 15, 2013, FDA’s online submission system, the electronic submissions gateway historically managed by the Center of Biologics Research and Evaluation (CBER), was breached by an unauthorized user. …To restore public confidence in the FDA’s information security, we request that you immediately obtain a third-party audit from a qualified expert to assess and ensure the adequacy of FDA’s corrective actions taken in response to this incident.”

To read the letter, click here.

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