After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA fees have been announced in a pre-publication of the FR here. So, this ends the announcements for the 2022 UFAs and you can take that to the bank!
The new PDUFA fees for FY 2022, along with those for FY 2021, are provided in the chart below.
| Fee Category | Fee Rates for 2021 | Fee Rates for 2022 | Percent Change |
| Application Requiring Clinical Data | $2,875,842 | $3,117,218 | 8.4% |
| Application Not Requiring Clinical Data | $1,437,921 | $1,558,609 | 8.4% |
| Program Fee | $336,432 | $369,413 | 9.8% |
So, there you have it! Costs keep going up, some years more than others, but this is the hand that the industry has been dealt. As the costs rise, new players may be priced out of the NDA market unless they have good capital backers.
