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FDA moves a step closer to executive prosecutions

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The FDA initiated 600 criminal prosecutions against companies in 1939 and it seems to be longing for the good old days. Its Office of Criminal Investigations, recently focused on fraud cases, appears ready for a shift to manufacturing as drug and device recalls grab headlines. CNN Money says the regulator has grown weary of protracted warning letter correspondence. It's studying the dusty Park Doctrine, under which it can prosecute corporate executives for manufacturing as well as other lapses. "It's going to happen. Do what you can and do the right thing before we find out about it," the story quotes an FDA official. Article


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