Transatlantic body to teach vital lessons about pros and cons of EU/US regulatory options?
This article was originally published in Clinica
The US FDA has once again attacked the EU medtech regulatory system. Its recent report, Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US, follows FDA head Jeff Shuren notoriously accusing the EU of treating its patients like guinea pigs (www.clinica.co.uk, 14 February 2011).
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