PDUFA vs GDUFA – Understanding the Key Differences and 15-Year Fee Trend Analysis (2010–2025)
📌 Introduction (Difference between PDUFA vs GDUFA)
The U.S. Food and Drug Administration (FDA) funds much of its drug review process through user fee programs. Two of the most important fee systems are:
- PDUFA – Prescription Drug User Fee Act (for new and branded drugs)
- GDUFA – Generic Drug User Fee Amendments (for generic drugs)
Both programs play a critical role in ensuring timely drug approvals while helping the FDA maintain regulatory efficiency.
What is PDUFA?
PDUFA (Prescription Drug User Fee Act) was first enacted in 1992. It allows the FDA to charge fees for:
- New Drug Applications (NDAs)
- Biologic License Applications (BLAs)
- Establishment and product reviews
These fees help reduce approval timelines from several years to around 10 months (standard review) or 6 months (priority review).
Key Features:
- Applies to 505(b)(1) and 505(b)(2) submissions
- Subject to waivers (e.g., orphan drugs)
- Reviewed under specific PDUFA Goals Letters
What is GDUFA?
GDUFA (Generic Drug User Fee Amendments) came into force in 2012. It enables the FDA to collect fees from:
- ANDA (Abbreviated New Drug Application) filers
- API (Active Pharmaceutical Ingredient) manufacturers
- FDF (Finished Dosage Form) facilities
GDUFA’s primary goal is to clear the generic drug backlog and improve transparency and quality in the generic drug industry.
Key Features:
- Applies only to generic manufacturers
- No exclusivity or priority review benefits
- Covers both domestic and foreign facilities
PDUFA vs GDUFA: Head-to-Head Comparison
| Feature | PDUFA | GDUFA |
|---|---|---|
| Year Introduced | 1992 | 2012 |
| Applies To | NDA/505(b)(1)/(2), BLA | ANDA, API & FDF facilities |
| Application Fee (2025 est.) | ~$4 million | ~$240,000 |
| Facility Fees | Establishment + Product fees | API & FDF facility fees |
| Fee Waivers | Yes (e.g., orphan drugs) | Limited |
| Review Timeline | 6–10 months | ~10 months |
| Exclusivity/Incentives | Yes (NCE, Orphan, Pediatric) | No |
| Reauthorization Cycle | Every 5 years | Every 5 years |
💰 15-Year FDA Fee Trend Analysis (2010–2025)
| Fiscal Year | PDUFA App Fee | Change % | ANDA Filing Fee | Change % | FDF Facility Fee | Change % | API Facility Fee | Change % |
|---|---|---|---|---|---|---|---|---|
| 2010 | $1,405,500 | — | N/A | — | N/A | — | N/A | — |
| 2013 | $1,958,800 | +39% | $51,520 | — | $175,000 | — | $26,000 | — |
| 2015 | $2,335,200 | +19% | $58,730 | +14% | $221,000 | +26% | $34,600 | +33% |
| 2018 | $2,421,495 | +3.7% | $171,823 | +193% | $211,087 | −4.5% | $45,367 | +31% |
| 2020 | $2,942,965 | +21.5% | $176,237 | +2.6% | $195,000 | −7.6% | $44,400 | −2.1% |
| 2022 | $3,117,218 | +5.9% | $225,712 | +28% | $213,134 | +9.3% | $45,367 | +2.2% |
| 2023 | $3,242,026 | +4% | $240,582 | +6.6% | $225,712 | +5.9% | $49,700 | +9.6% |
| 2025 (est.) | $4,000,000 | +23% | $240,000 | −0.2% | $230,000 | +1.9% | $51,500 | +3.6% |
Summary
- PDUFA supports branded/innovator drug applications and biologics with structured review timelines.
- GDUFA streamlines generic drug approval by funding ANDA reviews and international inspections.
- Fee growth is significant — planning regulatory budgets accordingly is crucial for pharmaceutical companies.
🔖 References
- FDA – PDUFA Program
- FDA – GDUFA Program
- Difference between PDUFA vs GDUFA
- Difference Between CEP, ASMF, and DMF | Pharma Regulatory Guide
- What is the difference between NDA vs ANDA vs Orphan Drugs
- What is EMA? History & Types of Variations for Medicines
- What is SmPC? A Complete Guide for Regulatory Compliance (2025)
- Nitrosamine Drug Substance-Related Impurities (NDSRIs)