Device Cos. Slam FDA's Overseas Clinical Trial Rule

Law360, New York (May 30, 2013, 6:21 PM EDT) -- A U.S. Food and Drug Administration proposal to strengthen oversight of overseas clinical trials involving medical devices ignores barriers presented by other countries’ laws and applies stricter rules than exist on American soil, several major manufacturers and the industry’s top trade group said in comments released Wednesday.

The Advanced Medical Technology Association led the charge in denouncing the proposed rule, saying the mandate that device makers receive study approval from an independent ethics committee and ensure the committee meets FDA standards would be impeded because not...
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