Posts Tagged "fda pressure"

F.D.A. Says It Approved Device in Error After Official Pressure

Posted on Oct 19, 2010 in Uncategorized

By GARDINER HARRIS WASHINGTON — The Food and Drug Administration vowed Thursday to reverse the approval of a patch for injured knees that it granted in 2008 after being pressured by four New Jersey congressmen and its own commissioner. The patch, known as Menaflex and manufactured by ReGen Biologics Inc., works in a fundamentally different way than devices that ReGen had claimed were similar enough that Menaflex did not need to be tested thoroughly, the F.D.A. decided. Its approval was an “error,” the agency said in a press release. “These differences can affect the safety and effectiveness...

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