FDA User Fees for Fiscal Year 2025 (FY2025)
The FDA’s user fees for FY2025, which runs from October 1, 2024, to September 30, 2025, apply to various industries, including pharmaceuticals, medical devices, biologics, and animal drugs. These fees help support the FDA’s regulatory and review processes, promoting efficient approval and compliance.
1. Prescription Drug User Fee Act (PDUFA) Fees
For human prescription drugs and biologics, PDUFA fees expedite the drug approval process:
- New Drug Application (NDA) with clinical data: $4,310,002
- NDA without clinical data: $2,155,001
- Program Fees (for approved drugs): $403,889 per product
2. Medical Device User Fee Amendments (MDUFA) Fees
MDUFA fees apply to medical devices to support review and regulation:
- 510(k) Premarket Notification Submission: $24,335
- Premarket Approval (PMA) Application: $540,783
- De Novo Classification Request: $162,235
- Annual Establishment Registration Fee: $9,280
3. Generic Drug User Fee Amendments (GDUFA) Fees
GDUFA applies to generic drug manufacturers to enhance the generic application review process:
- Abbreviated New Drug Application (ANDA) Fee: $252,453
- Program Fees:
- Large companies (20+ approved ANDAs): $1,891,664
- Medium companies (6-19 ANDAs): $756,666
- Small companies (1-5 ANDAs): $189,166
4. Biosimilar User Fee Act (BsUFA) Fees
BsUFA fees are for biosimilar biological products to aid in regulatory review:
- Application Fee (with clinical data): $1,471,118
- Application Fee (without clinical data): $735,559
- Biosimilar Program Fee: $256,168
5. Animal Drug User Fee Act (ADUFA) Fees
ADUFA fees apply to veterinary drug manufacturers:
- Animal Drug Application (NADA): $581,735
- Supplement requiring safety or efficacy data: $290,867
- Annual Product Fee: $10,705
- Annual Establishment Fee: $157,702
6. Animal Generic Drug User Fee Act (AGDUFA) Fees
AGDUFA supports generic animal drug manufacturers:
- Abbreviated New Animal Drug Application (ANADA): $161,907
- Annual Product Fee: $116,139
- Annual Establishment Fee: $157,702
7. Over-The-Counter (OTC) Monograph Drug User Fee
Fees for non-prescription drugs marketed under OTC monographs:
- OTC Monograph Order Request (Tier 1): $559,777
- OTC Monograph Order Request (Tier 2): $111,955
- Annual OTC Monograph Drug Facility Fees:
- Monograph Drug Facility (MDF): $34,166
- Contract Manufacturing Organization (CMO) MDF: $22,777
Key Notes
- Establishment Fees: Annual registration fees apply to industries like medical devices, prescription drugs, and animal drugs.
- Small Business Reductions: Some fees may be reduced for small businesses in medical devices and pharmaceuticals that meet eligibility criteria.
- Annual Adjustments: The FDA reviews and adjusts these fees annually based on inflation and regulatory demands to improve review efficiency and post-market safety.
How Quality Smart Solutions Can Help
Keeping up with regulatory fees and submission requirements is crucial for your business’s success in FDA-regulated industries. Quality Smart Solutions is here to simplify the registration and compliance process for your company, whether you’re working with the FDA, Health Canada, or the European Food Safety Authority (EFSA). Contact Quality Smart Solutions today to ensure smooth, cost-effective compliance that aligns with the latest regulatory standards.
