Home > Newsletters > FDAnews Device Daily Bulletin > FDA Warns Against Untested MS Treatment, Calls for Rigorous Studies
FDAnews Device Daily Bulletin
May 23, 2012 | Vol. 9 No. 102
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
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.