FDA announced on August 1, 2008 the user fees for fiscal year 2009 (the U.S. government 2009 fiscal year start on October 1, 2008). The fees are based on PDUFA IV approved last year. The application fee for an application requiring clinical data is $1,247,200, for an application not requiring clinical data or a supplement requiring clinical data ($623,600), for establishment fees ($425,600), and for product fees ($71,520).
Small businesses (less than 500 employees) still enjoy a free first filing. Successive filings are subject to PDUFA fees. Note that it may be possible to obtain a reduction in fees depending on the firms financial strength.