FDA Admits Knee Device Approval Was Compromised

Law360, New York (September 25, 2009, 5:44 PM EDT) -- The U.S. Food and Drug Administration's clearance of a ReGen Biologics Inc. knee device was compromised by Capitol Hill pressure and a lack of safety data, the FDA revealed in a report that calls for a review of the regulator's approval processes.

On Thursday, the FDA released a 33-page report outlining “multiple departures” from its standard processes for the approval of a device that supports tissue growth after knee injuries, marketed as Menaflex.

The FDA's departures included succumbing to pressure to approve the device from a...
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