Difference between PDUFA vs GDUFA

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

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