FDA posts FY2023 user fee tables
The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2023 from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices. The table below lists the user fees for each program.Each year, FDA adjusts its user fees based on factors such as inflation and the number of applications or establishments expected to pay the various fees; this year’s update has more significance as it marks the start of the new five-year user fee programs.
For FY2023, FDA’s fee for new drug applications (NDAs) and biologics license applications (BLAs) are set to go up 4% while certain biosimilar applications are set to go down about 17%. The most dramatic increase for this year’s user fees comes from the device user fee program where most application fees are going up 18% while fees on 510(k) premarket notification submissions will increase 56%.
| FDA User Fee Table | FY2023 Fee Rate | FY2022 Fee Rate | Change | Percent Change |
| Prescription Drug User Fee Amendment (PDUFA VII) | ||||
| Application requiring clinical Data | $3,242,026 | $3,117,218 | $124,808 | 4% |
| Application not requiring clinical data | $1,621,013 | $1,558,609 | $62,404 | 4% |
| Program Fee | $393,933 | $369,413 | $24,520 | 7% |
| Generic Drug User Fee Amendment (GDUFA III) | ||||
| Abbreviated new drug application (ANDA) | $240,582 | $225,712 | $14,870 | 7% |
| Drug master file (DMF) | $78,293 | $74,952 | $3,341 | 4% |
| Facility: | ||||
| Active pharmaceutical ingredient (API) – Domestic | $37,544 | $42,557 | -$5,013 | -12% |
| API – Foreign | $52,544 | $57,557 | -$5,013 | -9% |
| Finished dosage form (FDF) – Domestic | $213,134 | $195,012 | $18,122 | 9% |
| FDF – Foreign | $228,134 | $210,012 | $18,122 | 9% |
| Contract manufacturing organization (CMO) – Domestic | $51,152 | $65,004 | -$13,852 | -21% |
| CMO – Foreign | $66,152 | $80,004 | -$13,852 | -17% |
| GDUFA program: | ||||
| Large size operation generic drug applicant | $1,620,556 | $1,536,856 | $83,700 | 5% |
| Medium size operation generic drug applicant | $648,222 | $614,742 | $33,480 | 5% |
| Small business operation generic drug applicant | $162,056 | $153,686 | $8,370 | 5% |
| Biosimilar User Fee Amendment (BSUFA III) | ||||
| Initial biological product development (BPD) | $47,325 | $57,184 | -$9,859 | -17% |
| Annual BPD | $47,325 | $57,184 | -$9,859 | -17% |
| Reactivation | $94,650 | $114,368 | -$19,718 | -17% |
| Applications requiring clinical data | $1,746,745 | $1,746,745 | $0 | 0% |
| Applications not requiring clinical data | $873,373 | $873,373 | $0 | 0% |
| Program | $304,162 | $304,162 | $0 | 0% |
| Medical Device User Fee Amendment (MDUFA V) | ||||
| Premarket approval (PMA) or Biologics License Application (BLA) standard fee | $441,547 | $374,858 | $66,689 | 18% |
| Premarket approval (PMA) or Biologics License Application (BLA) small business fee | $110,387 | $93,714 | $16,673 | 18% |
| Premarket report standard fee | $441,547 | $374,858 | $66,689 | 18% |
| Premarket report small business fee | $110,387 | $93,714 | $16,673 | 18% |
| Efficacy supplement to an approved BLA standard fee | $441,547 | $374,858 | $66,689 | 18% |
| Efficacy supplement to an approved BLA small business fee | $110,387 | $93,714 | $16,673 | 18% |
| Panel-track supplement standard fee | $353,238 | $281,143 | $72,095 | 26% |
| Panel-track supplement small business fee | $88,309 | $70,286 | $18,023 | 26% |
| De novo classification request standard fee | $132,464 | $112,457 | $20,007 | 18% |
| De novo classification request small business fee | $33,116 | $28,114 | $5,002 | 18% |
| 180-day supplement standard fee | $66,232 | $56,229 | $10,003 | 18% |
| 180-day supplement small business fee | $16,558 | $14,057 | $2,501 | 18% |
| Real-time supplement standard fee | $30,908 | $26,240 | $4,668 | 18% |
| Real-time supplement small business fee | $7,727 | $6,560 | $1,167 | 18% |
| 510(k) standard fee | $19,870 | $12,745 | $7,125 | 56% |
| 510(k) small business fee | $4,967 | $3,186 | $1,781 | 56% |
| 30-day notice standard fee | $7,065 | $5,998 | $1,067 | 18% |
| 30-day notice small business fee | $3,532 | $2,999 | $533 | 18% |
| 513(g) request for classification information standard fee | $5,961 | $5,061 | $900 | 18% |
| 513(g) request for classification information small business fee | $2,980 | $2,530 | $450 | 18% |
| Annual fee for periodic reporting on a Class III device standard fee | $15,454 | $13,120 | $2,334 | 18% |
| Annual fee for periodic reporting on a Class III device small business fee | $3,864 | $3,280 | $584 | 18% |
| Annual establishment registration fee standard fee | $6,493 | $5,672 | $821 | 14% |
| Annual establishment registration fee small business fee | $6,493 | $5,672 | $821 | 14% |
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