GSK's China Misadventures Put Heat On Foreign Drug Trials

Law360, New York (July 24, 2013, 8:24 PM EDT) -- The recently revealed compliance failures at GlaxoSmithKline PLC's research center in China could convince the U.S. Food and Drug Administration, already wary of foreign clinical trials, to enhance its oversight of overseas drug and medical device research, experts say.

The New York Times reported Monday that a 2011 audit found that the drugmaker's research and development site in Shanghai failed to report animal study results for a drug already being tested on people, failed to properly monitor clinical trials, and breached other research protocols. GSK admitted...
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