FDA Warns Against Untested MS Treatment, Calls for Rigorous Studies

The FDA is advising physicians and clinical trial sites that may be studying an experimental procedure for multiple sclerosis (MS) that they need to get investigational device exemption (IDE) approval to proceed. The mid-May alert follows a February FDA warning to an Albany, N.Y., clinical trial site that was using “liberation therapy” to treat patients with chronic cerebrospinal venous insufficiency without an IDE. The Vascular Group has since ceased enrollment in the study.
Devices & Diagnostics Letter