“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe
This article was originally published in The Gray Sheet
Executive SummaryFDA's device center has until Dec. 1 to respond to a Congressional inquiry into allegations of wrongdoing in its pre-market review process
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LivaNova's RECOVER trial will randomize about 1,000 patients with treatment-resistant depression to either LivaNova’s vagus nerve stimulation therapy or a sham therapy and follow them for at least a year.
During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.
A powerful former Chairman of the House Energy and Commerce Committee, Dingell has been not only a major player in the health care reform fight, but also a vigorous prober of FDA, launching investigations with lasting effects on the device center. The longest-serving member of the House announced his plans to retire at the end of this congressional term.