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Regulatory Affairs Medtech
European Commission complains to US FDA over criticism of EU system
01 March 2011
Amanda Maxwell

The European Commission has written to the US Food and Drug Administration objecting to the apparent suggestion by the agency’s devices centre head that the EU treats its patients as rodents in medical device experiments.

Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, made comments implying EU patients using medical devices were like “guinea pigs” while aiming to defend the US medtech regulatory system1...

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