CDRH's Shuren Touts Improvements in FDA Process (HealthPointCapital)
Copy of Dr Shuren's slides --> Dr Shuren - Memphis 11June12
In comments delivered in Memphis this week, CDRH Director Jeff Shuren announced that efforts to improve efficiency and speed up the regulatory process are paying off. Dr. Shuren said that decision times are decreasing and the FDA is engaging in less back-and-forth with devicemakers, and that progress will only continue with the support from the newly-authorized MDUFA III. "The good news is we're seeing the canary in the coal mine is actually singing these days,...