In a Federal Register notice published today, the FDA outlined the new fiscal year Prescription Drug User Fees here.
Fees are applicable for any application submitted after October 1, 2013, the start of FDA’s fiscal year.
The fees are as follows:
NDA with clinical studies $2,169,100 up from $1,958,800 for FY 2013
NDA no clinical studies $1,084,550 up from $ 979,400 for FY 2013
Establishment fees $554,600 up from $526,500 for FY 2013
Product fees $104,060 up from $98,380 for FY 2013
Last year, a couple of the fees actually dropped a bit, but not this year. Get ready for the October 1, 2013 date and adjust your financial projections accordingly.