Breakthrough Therapy: 'A Lower Bar Of Evidence'?
MedPAC meeting elicits negative view of designation from one members and no one disagreed. Should US FDA reiterate what the special designation actually means?
You may also be interested in...
US FDA's accelerated approval pathway is more reliable and has better validated biomarkers than a decade ago, commissioner says, arguing coverage limits on AA products are not in the interest of public health.
With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.
With two landmark advisory committee meetings coming up, the Pink Sheet reflects on some of the most memorable panel meetings over the last 20 years.