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The Food and Drug Administration and its Center for Devices and Radiological Health ( CDRH) is reeling.
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This grueling internal battle appears to have left the CDRH, the FDA office empowered to oversee innovative medical technology devices, including genetic tests, in disarray.
FORBES: FDA SpyGate -- New Revelations Challenge The New York Times Investigation of Agency "Enemies List," Raise More Questions About the 'Government's Most Dysfunctional Agency'
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Hamburg and Jeffrey Shuren, the director of the Center for Devices and Radiological Health, also have stumbled in a ham-handed attempt, announced two years ago, to expand regulatory control over the genetic testing industry, also regulated by CDRH.
FORBES: FDA SpyGate -- New Revelations Challenge The New York Times Investigation of Agency "Enemies List," Raise More Questions About the 'Government's Most Dysfunctional Agency'