FDA Loss May Draw Drug-Device Makers To Policy Fight

Law360, New York (September 28, 2012, 7:39 PM EDT) -- A ruling that the U.S. Food and Drug Administration improperly classified a drug-and-device combination product as a drug — a more expensive designation that many sponsors try to avoid — may not change how the FDA designates combo products, experts say, but should encourage more unhappy sponsors to appeal.

A Washington, D.C., federal judge ruled Tuesday that the FDA had acted arbitrarily and capriciously when it designated a combination product made by the French company Prevor as primarily a drug, rather than a device. The product,...
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