2009JAMARequires access

FDA Whistleblowers

Mike Mitka

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Abstract

A group of scientists within the Food and Drug Administration's (FDA’s) Center for Devices and Radiological Health (CDRH) said some of their managers corrupted the scientific review process and approved or cleared medical device applications in gross violation of federal laws and regulations.

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What this paper is about

A group of scientists within the Food and Drug Administration's (FDA’s) Center for Devices and Radiological Health (CDRH) said some of their managers corrupted the scientific review process and approved or cleared medical device applications in gross violation of federal laws and regulations.

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Available abstract

A group of scientists within the Food and Drug Administration's (FDA’s) Center for Devices and Radiological Health (CDRH) said some of their managers corrupted the scientific review process and approved or cleared medical device applications in gross violation of federal laws and regulations.

Key concepts: Medicine, Clearance, Food and drug administration, Radiological weapon, Administration (probate law), Law, Medical emergency, Surgery

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