FDA approval rate up 7% in 2012, but still trails EU
This article was originally published in Scrip
Executive Summary
The US FDA upped its approval rate in fiscal 2012 to 76%, from 69% in 2011, the BioMedTracker 2012 FDA and EMA Approval Report from Sagient Research Systems’ BioMedTracker has found. It also approved a much higher proportion of new entities (rather than new indications for existing entities) than in previous years.