Posted by Michael Wonder on 02 Nov 2016
Generic drug backlog at the FDA: a dive into the confusing numbers
2 November 2016 - As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: reduce the generic drug backlog at the US FDA, create more competition and drug prices will come down.
But is the generic drug backlog, also known as the abbreviated new drug application (ANDA) backlog, that big of a problem? Or is confusion over what exactly this backlog means and how long it takes FDA to approve generic drugs creating the mirage of a problem?
