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Distinguishing Scandal from Management Problems

This article was originally published in RAJ Devices

Executive Summary

With phrases like “intimidation and coercion”, “silent danger” and “management reprisals” being thrown around, one could be forgiven for assuming the words are extracts from the latest best-selling fiction. They are, in fact, from a letter written by the US Food and Drug Administration’s own medical device review staff accusing top management at the agency’s Center for Devices and Radiological Health of knowingly corrupting the scientific review process1. As the scandal continues to escalate, perhaps some reflection is called for. Has criminal misconduct really taken place, or is it a case of poor management that has been blown out of proportion and politicised?

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