Nissen: FDA removal of Avandia restrictions wrong, but unlikely to matter
This article was originally published in Scrip
Executive Summary
Even though the FDA may not have all of the answers about the cardiovascular (CV) safety of GlaxoSmithKline's type 2 diabetes drug Avandia (rosiglitazone), US regulators on 25 November felt comfortable enough to lift the restrictions the agency imposed on the medicine three years ago – reversing course on what it initially had concluded about a 2007 meta-analysis.