Will the FDA grant IDE exemptions to CCSVI research? Yes!
Posted: Sun Jun 10, 2012 2:12 pm
Dr. Siskin has been granted the IDE exemption from the FDA in order to research CCSVI.
There has been concern since the FDA warning and the termination of Dr. Mehta's study, which had failed to get an IDE prior to commencing, that the FDA would be unduly uncooperative about the IDE process, or would outright deny. It is a positive sign that they have allowed Dr. Siskin's study to proceed, and I would hope other research studies will receive the same.
