Avandia and the Commercial Impact of FDA's Credibility Gap
This article was originally published in RPM Report
Executive Summary
GlaxoSmithKline's diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA's credibility.
You may also be interested in...
The Era of Drug Efficacy
FDA has been perceived by drug developers as a regulator obsessed with drug safety. But recent cases show serious safety concerns aren’t holding back new products: efficacy has been the deciding factor for approval.
The Era of Drug Efficacy
FDA has been perceived by drug developers as a regulator obsessed with drug safety. But recent cases show serious safety concerns aren’t holding back new products: efficacy has been the deciding factor for approval.
FDA's Special Relationship with NEJM
Under Commissioner Hamburg, the New England Journal of Medicine has been a common vehicle for the agency’s public health messages. Here is the back story.