FDA unveils FY 2025 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter monograph drug programs. The rates are calculated by factoring in its resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends.PDUFA
FDA estimates the base revenue for FY 2025 for the Prescription Drug User Fee Amendment (PDUFA VII) at $1,358,764,346 before factoring in inflation and other factors. The new estimate is more than an 8% increase compared to its FY 2024 estimate of $1,256,844,387.
| PDUFA Fee Category | FY 2024 Rates | FY 2025 Rates | Percent Change |
| Applications Requiring Clinical Data | $4,048,695 | $4,310,002 | 6% |
| Applications Not Requiring Clinical Data | $2,024,348 | $2,155,001 | 6% |
| Program | $416,734 | $403,889 | -3% |
GDUFA
FDA estimates the base revenue for FY 2025 for the Generic Drug User Fee Amendment (GDUFA III) at $613,538,015 before considering inflation and other factors. The new estimate is more than a 5% increase compared to its FY 2024 estimate of $582,500,000.
| GDUFA Fee Category | FY 2024 Rates | FY 2025 Rates | Percent change |
| ANDA | $252,453 | $321,920 | 28% |
| Drug Master File | $94,682 | $95,084 | 0% |
| Domestic API Facility | $40,464 | $41,580 | 3% |
| Foreign API Facility | $55,464 | $56,580 | 2% |
| Domestic FDF Facility | $220,427 | $231,952 | 5% |
| Foreign FDF Facility | $235,427 | $246,952 | 5% |
| Domestic CMO Facility | $52,902 | $55,668 | 5% |
| Foreign CMO Facility | $67,902 | $70,668 | 4% |
| Generic Drug Applicant - Large Firm | $1,729,629 | $1,891,664 | 9% |
| Generic Drug Applicant - Medium Firm | $691,852 | $756,666 | 9% |
| Generic Drug Applicant - Small Firm | $172,963 | $189,166 | 9% |
BsUFA
Based on what was agreed to under the Biosimilar User Fee Amendments (BsUFA III), FDA estimated that its base revenue from the program for FY 2025 needs to bring in $51,058,823 before being adjusted for inflation, hiring, operating costs, and other factors. That’s a 4.8% increase from the $48,700,243 base revenue that was projected by the agency for FY 2024.
FDA said it expects about 23 new biological product development (BPD) programs in FY 2025 and an additional 88 BPD programs to pay the annual BPD fee, which brings the total number of applications to 111.
| BsUFA Fee Category | FY 2024 | FY 2025 | Percent Change |
| Initial BPD | $10,000 | $10,000 | 0% |
| Annual BPD | $10,000 | $10,000 | 0% |
| Reactivation | $20,000 | $20,000 | 0% |
| Applications Requiring Clinical Data | $1,018,753 | $1,471,118 | 44% |
| Not Requiring Clinical Data | $509,377 | $735,559 | 44% |
| Program Fee | $177,397 | $256,168 | 44% |
MDUFA
FDA estimates the base revenue for FY 2025 for the Medical Device User Fee Amendment (MDUFA V) at $350,746,400 before factoring in inflation and other factors. The new estimate is more than a 4% increase compared to its FY 2024 estimate of $335,750,000.
| MDUFA Application Type | FY 2024 | FY 2025 | Percent Change |
| Full Fee Applications | $483,560 | $540,783 | 12% |
| Small Business | $120,890 | $135,196 | 12% |
| Panel-Track Supplement | $386,848 | $432,626 | 12% |
| Small Business | $96,712 | $108,157 | 12% |
| De Novo | $145,068 | $162,235 | 12% |
| Small Business | $36,267 | $40,559 | 12% |
| 180-Day Supplement | $72,534 | $81,117 | 12% |
| Small Business | $18,134 | $20,279 | 12% |
| Real-Time Supplement | $33,849 | $37,855 | 12% |
| Small Business | $8,462 | $9,464 | 12% |
| 510(k) | $21,760 | $24,335 | 12% |
| Small Business | $5,440 | $6,084 | 12% |
| 30-Day Notice | $7,737 | $8,653 | 12% |
| Small Business | $3,869 | $4,326 | 12% |
| 513(g) | $6,528 | $7,301 | 12% |
| Small Business | $3,264 | $3,650 | 12% |
| Annual Periodic Reporting | $16,925 | $18,927 | 12% |
| Small Business | $4,231 | $4,732 | 12% |
OMUFA
FDA also published its Over-the-Counter (OTC) Monograph Drug User Fee Amendment (OMUFA) program user fee rates for FY 2025. The agency did not publish monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates or its base revenue expectations alongside its monograph order request (OMOR) fee rates, which it said it would publish later.
| OMUFA Fee Category | FY 2024 | FY 2025 | Percent Change |
| Tier 1 OMOR fee | $537,471 | $559,777 | 4% |
| Tier 2 OMOR fee | $107,494 | $111,955 | 4% |
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