FDA Import Reforms To Fuel Fights Over Drugmaking Slip-Ups

Law360, New York (February 20, 2014, 1:40 PM EST) -- The U.S. Food and Drug Administration is unleashing a barrage of quality-control initiatives aimed at overseas drug manufacturing, potentially empowering prosecutors and litigious investors who are eager to make hay over sloppy production.

The campaign took center stage during a high-profile trip to India this month by FDA Commissioner Margaret Hamburg, who chastised the country's regulators for not cooperating more with their foreign counterparts and voiced little sympathy for industry complaints about aggressive inspections.

FDA officials this week also launched a pilot project that loosens import...
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