Schultz’ Controversial Approval Of Cyberonics Device Has Little Precedent
This article was originally published in The Gray Sheet
Executive Summary
CDRH Director Dan Schultz's decision to override device and drug center review staff to approve Cyberonics' VNS Therapy neurostimulation device for treatment-resistant depression has scant precedent in recent history. All the same, he appears to have followed established FDA procedures
You may also be interested in...
Former ODE Staffers Dispute Claims Of Office Corruption And Coercion
Public censure of FDA's device center is escalating, but former Office of Device Evaluation staffers who spoke to "The Gray Sheet" paint a different picture of the review process than the corrupt image that has surfaced in recent months
Former ODE Staffers Dispute Claims Of Office Corruption And Coercion
Public censure of FDA's device center is escalating, but former Office of Device Evaluation staffers who spoke to "The Gray Sheet" paint a different picture of the review process than the corrupt image that has surfaced in recent months
“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe
FDA's device center has until Dec. 1 to respond to a Congressional inquiry into allegations of wrongdoing in its pre-market review process