FDA Will Relax Premarket Requirements To Enable LVAD Randomized Trials
This article was originally published in The Gray Sheet
Randomized, controlled trials supporting PMAs for left-ventricular assist devices as destination therapy should compare the investigational device with an already approved LVAD, according to FDA
You may also be interested in...
Thoratec is in negotiations with NIH to restrict access to control group data from the REMATCH randomized trial of the HeartMate VE upon the study's completion
The president’s executive order aims to give smaller companies a leg up over foreign competitors, among other objectives.
No device-related warning letters were released by the US FDA the week of 26 January.