The announcement in the prepublication of the Federal Register of the new FY 2027 PDUFA user fees for NDAs and BLAs might be a bit of a pleasant surprise to sponsors as the decrease in fees is something we usually do not see. Perhaps it is due to the significant staff reductions seen during the DOGE disruptions or the fact that, in the past few years, there has been a resurgence of fee paying applications after a few years of dips.
The calculation of the application fee is based on the 10-year average of fee-paying applications submitted (the process for setting the fee is explained in further detail in the FR notice cited above). The program fee is assessed for different prescription drug products (e.g. different strengths) contained in the same application; however, no more than five can be assessed for each application. Program fees will be set to generate 80% of the total target revenue, while fee-paying applications will be set to generate 20% of fees in FY 2027.
The new fees go into effect October 1, 2026. Bet you did not expect to save a few bucks on fees in 2027!
(Note there was an earlier version of this post you might have seen that had erroneous FY 2026 figures. I apologize for the error.)
