“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe
This article was originally published in The Pink Sheet Daily
Executive Summary
Reps. Dingell, Stupak call whistleblower evidence FDA managers corrupted scientific review of devices "compelling."
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FDA Cannot Escape Congressional Crosshairs
House Republicans question Commissioner von Eschenbach on whether Office of Criminal Investigations is the best use of limited resources.
FDA Cannot Escape Congressional Crosshairs
House Republicans question Commissioner von Eschenbach on whether Office of Criminal Investigations is the best use of limited resources.
GAO Drafts 510(k) Report; Talk Grows Of Pre-Market Reform Legislation In ’09
After some delay, the Government Accountability Office has drafted a report on FDA's 510(k) submissions program, which some expect will recommend reforms to the Class II, medium-risk category of devices