FDA Says It Caved To Politics In Clearing ReGen Implant

Law360, Washington (March 14, 2013, 10:28 PM EDT) -- The U.S. Food and Drug Administration said Thursday it had acted within its authority when it rescinded marketing clearance for a ReGen Biologics Inc. knee implant — an action the company says drove it into bankruptcy — because the device had gotten initial approval only due to "severe political pressure."

FDA attorneys claimed during a summary judgment hearing Thursday that the agency was under “one of the most severe political pressures” it had ever seen when it first approved ReGen's collagen meniscus implant, Menaflex, as a...
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