US FDA announces increase in PDUFA fee rates for FY 2011
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has announced the fees it will charge for reviewing prescription drug submissions in fiscal year 2011, reflecting an overall increase compared with the previous year1. The fee for assessing an application requiring clinical data, for example, has been increased by around 9.7% – just over $1.5 million in FY 2011 as compared with approximately $1.4 million in FY 2010.