Avandia Revisited: Will New Findings Lead To Reevaluation of Drug Center's Structure?
This article was originally published in RPM Report
Senate Finance Committee report and internal FDA analysis on cardiovascular risks associated with GSK's Avandia may revive argument to split CDER into two groups of safety and efficacy reviewers.
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.
Lessons Learned: How Avandia is Changing the Way FDA Does Business
FDA learned two important lessons from the Avandia debacle. First, the agency needs to be a better communicator—which means telling the public more about what it knows (and doesn’t know) about the safety of marketed products. But Avandia is also leading the agency to rethink what should be required to demonstrate safety, especially for chronic care therapies. Both could mean big changes for industry.
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.