There are few drugs approved by FDA that open old regulatory wounds like GlaxoSmithKline's Avandia.
The Type II diabetes therapy has been the subject of intense scrutiny by Congress and FDA ever since Cleveland Clinic...
Avandia Revisited: Will New Findings Lead To Reevaluation of Drug Center's Structure?
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.