FDA Publishes FY 2014 PDUFA Fees

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.