After six years of public debate, an FDA panel put to rest many of the concerns about the cardiovascular safety of Avandia rosiglitazone using a mix of observational studies, meta-analyses and controlled trials. The panel's deliberations could shed light on how to balance and interpret such data as the agency is increasingly faced with a similar melange of real-world and clinical data to evaluate the benefit and risks of drugs in the postmarket.

At a joint meeting of the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management advisory committees last week, panel members voted to relax the REMS on diabetes drug Avandia from GlaxoSmithKline plc.