FDA reflects on DES advisory panel
This article was originally published in The Gray Sheet
Executive Summary
Agency pledges to work closely with drug-eluting stent makers to revise DES labeling, as well as pre- and post-approval DES study protocols, in light of recommendations made by its Circulatory System Devices Advisory Panel during a Dec. 7-8 meeting assessing the risk of late stent thrombosis (1"The Gray Sheet" Dec. 11, 2006, p. 3). FDA notes that more data is needed to better assess on- and off-label use of DES. The agency's comments are part of a larger review of the advisory panel's findings, published Jan. 4 on the agency's Web site...