Senate Report Scrutinizes Schultz’ Role In Cyberonics’ Device Approval
This article was originally published in The Gray Sheet
Executive Summary
A Senate Finance Committee report scrutinizes CDRH Director Daniel Schultz' role in FDA's controversial decision to approve Cyberonics' VNS Therapy neurostimulation device for treatment-resistant depression (TRD) in July 2005
You may also be interested in...
Increasing Number Of Appeals Add To Unresolved Issues For Ombudsman
CDRH's ombudsman says more manufacturer appeals of decisions made by the device center's evaluation office are causing longer resolution times for many complaints and disputes filed with the center
Increasing Number Of Appeals Add To Unresolved Issues For Ombudsman
CDRH's ombudsman says more manufacturer appeals of decisions made by the device center's evaluation office are causing longer resolution times for many complaints and disputes filed with the center
Digene Reaches Investors And Consumers With Ads; OTC Index Up 4.4%
Digene's direct-to-consumer advertising campaign persuaded consumers and investors that its HPV Test is the standard of care for cervical cancer screening, driving the firm's stock up 34% to close the first quarter at $39.10