Just after we posted the blog about the other User Fee programs from the prepublication of the Federal Register, we receive an email from FDA indicating that the Fee Schedule was available, but there was a problem with the FR publication (here).

Here are the new FY 2023 Generic Drug User Fees compared with the FY 2022 fees.

Generic Fee Category FY 2022 Fees FY 2023 Fees Change
ANDA $225,712 $240,582 +$14,870
DMF $74,952 $78,293 +$3,341
Active Pharmaceutical Ingredient (API) Domestic $42,557 $37,544 -$5,013
API Foreign $57,557 $52,544 -$5,013
Finished Dose Form (FDF) Domestic $195,012 $213,134 +$18,122
FDF Foreign $210,012 $228,134 +$18,122
Contract MFG Organization (CMO) Domestic $65,004 $51,152 -$13,852
CMO Foreign $80,004 $66,152 -$13,852
GDUFA Program Fees
Large Size 20 or more ANDAs $1,536,856 $1,620,556 +$83,700
Medium Size 6-19 ANDAs $614,742 $648,222 +$33,480
Small <5 ANDAs $153,686 $162,056 +$8,370


The GDUFA Fees were a mixed bag this year with application fees going up, API Facility fees going down, FDF fees rose while CMO fees fell, and all of the program fees rose. The Notice for the fees carries this notation – “Under sections 744B(a)(4) and (5) of the FD&C Act, respectively, facility and program fees are generally due on the later of the first business day on or after October 1 of each fiscal year, or the first business day after the enactment of an appropriations act providing  for the collection and obligation of GDUFA fees for the fiscal year. Here, that date is October 3, 2022. However, given the late date of the GDUFA reauthorization for FYs 2023 through 2027, facility and program fees for FY 2023 should be paid within 30 days from the issue date of this notice.”

Details of the fee adjustments appear in the FR notice cited above and will appear in the October 12, edition of the Federal Register.