PDUFA Fees for FY 2019 Announced

A Federal Register Notice (here) released today announced the new Prescription Drug User Fees (PDUFA fees) for FY 2019.  And while there had been a modest increase, the fact is the there is an increase signifies that there is little expectation that fees will retreat anytime in the next few years.  The PDUFA total budget for FY 2019 is has exceeded the 1-billion-dollar mark, $1,010,322,000 for FY 2019 after all of the various adjustments are made for the new FY.

PDUFA Fees for FY 2019

 

Please read the FR notice cited above for the details on the various increases and estimates of fee paying applications.