FDA, Rising? Oversight May Increase for Devices, Drugs

Law360, New York (August 18, 2010, 3:43 PM EDT) -- The U.S. Food and Drug Administration has faced intense criticism, as commentators have raised serious questions about its ability to protect the nation’s medical drug and device supply. Less visibly, but just as strongly, manufacturers have identified the need for more certainty and greater efficiencies in regulatory interactions.

Two recent developments reflect the potential that the FDA will be increasing its muscle. Working groups from within the FDA have proposed revisions to the way the agency evaluates medical devices. Although some streamlining would occur, the net...
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