FDA unveils FY 2026 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2026 across its prescription drug, generic drug, biosimilar, and medical device programs. The rates are calculated by factoring in the agency’s 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 2026 for the Prescription Drug User Fee Amendment (PDUFA VII) at $1,434,377,467 before inflation and other factors are considered. The new estimate is almost a 6% increase compared to its FY 2025 estimate of $1,358,764,346.
| PDUFA Fee Category | FY 2025 Rates | FY 2026 Rates | Percent Change |
| Applications Requiring Clinical Data | $4,310,002 | $4,682,003 | 9% |
| Applications Not Requiring Clinical Data | $2,155,001 | $2,341,002 | 9% |
| Program | $403,889 | $442,213 | 9% |
GDUFA
FDA estimates the base revenue for FY 2026 for the Generic Drug User Fee Amendment (GDUFA III) at $638,961,803 before considering inflation and other factors. The new estimate is more than a 4% increase compared to its FY 2024 estimate of $613,538,015.
| GDUFA Fee Category | FY 2025 Rates | FY 2026 Rates | Percent change |
| ANDA | $321,920 | $358,247 | 11% |
| Drug Master File | $95,084 | $102,584 | 8% |
| Domestic API Facility | $41,580 | $43,549 | 5% |
| Foreign API Facility | $56,580 | $58,549 | 3% |
| Domestic FDF Facility | $231,952 | $238,943 | 3% |
| Foreign FDF Facility | $246,952 | $253,943 | 3% |
| Domestic CMO Facility | $55,668 | $57,346 | 3% |
| Foreign CMO Facility | $70,668 | $72,346 | 2% |
| Generic Drug Applicant - Large Firm | $1,891,664 | $1,918,377 | 1% |
| Generic Drug Applicant - Medium Firm | $756,666 | $767,351 | 1% |
| Generic Drug Applicant - Small Firm | $189,166 | $191,838 | 1% |
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 2026 needs to bring in $56,011,943 before being adjusted for inflation, hiring, operating costs, and other factors. That’s an almost 10% increase from the $51,058,823 base revenue that was projected by the agency for FY 2025.
FDA said it expects about 30 new biological product development (BPD) programs in FY 2026 with no reactivations. That seven more BPDs from its FY 2025 estimate of 23. It expects an additional 120 BPD programs to pay the annual BPD fee, up from 88 in FY 2025, which brings the total number of estimated applications to 150.
While FDA raised BsUFA fees by 44% last fiscal year, it expects to lower them by 18% next year.
| BsUFA Fee Category | FY 2025 | FY 2026 | 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 | $1,471,118 | $1,200,794 | -18% |
| Not Requiring Clinical Data | $735,559 | $600,397 | -18% |
| Program Fee | $256,168 | $209,097 | -18% |
MDUFA
FDA estimates the base revenue for FY 2026 for the Medical Device User Fee Amendment (MDUFA V) at $366,486,300 before factoring in inflation and other factors. The new estimate is almost a 4.5% increase compared to its FY 2025 estimate of $350,746,400.
The following table shows the adjusted FY 2026 fees to meet FDA's revenue targets. The agency expects to increase rates by 7%.
| MDUFA Application Type | FY 2025 | FY 2026 | Percent Change |
| Full Fee Applications | $540,783.00 | $579,272.00 | 7% |
| - Small Business | $135,196.00 | $144,818.00 | 7% |
| Panel-Track Supplement | $432,626.00 | $463,418.00 | 7% |
| - Small Business | $108,157.00 | $115,855.00 | 7% |
| De Novo | $162,235.00 | $173,782.00 | 7% |
| - Small Business | $40,559.00 | $43,446.00 | 7% |
| 180-Day Supplement | $81,117.00 | $86,891.00 | 7% |
| - Small Business | $20,279.00 | $21,723.00 | 7% |
| Real-Time Supplement | $37,855.00 | $40,549.00 | 7% |
| - Small Business | $9,464.00 | $10,137.00 | 7% |
| 510(k) | $24,335.00 | $26,067.00 | 7% |
| - Small Business | $6,084.00 | $6,517.00 | 7% |
| 30-Day Notice | $8,653.00 | $9,268.00 | 7% |
| - Small Business | $4,326.00 | $4,634.00 | 7% |
| 513(g) | $7,301.00 | $7,820.00 | 7% |
| - Small Business | $3,650.00 | $3,910.00 | 7% |
| Annual Periodic Reporting | $18,927.00 | $20,275.00 | 7% |
| - Small Business | $4,732.00 | $5,069.00 | 7% |
