Many years ago, around the time when the US FDA was considering a “reevaluation” of the erythropoiesis-stimulating agents (ESAs) with a forthcoming advisory committee, the agency's dean of drug development Bob Temple was asked how the agency prepared for a panel meeting.
The 'Dead Cat' Strikes Back: What Does US FDA Do With A Challenging Panel Outcome?
Akcea’s volanesorsen for familial chylomicronemia syndrome barely made it through advisory committee due to a rare but unpredictable and rapidly presenting adverse event that likely can’t be resolved with a REMS. Now what?
