The demand for generic drugs continues to grow globally, but with opportunity comes scrutiny. To ensure the safety, quality, and timely availability of generic medications, the U.S. Food and Drug Administration (FDA) administers the Generic Drug User Fee Amendments (GDUFA)—a powerful regulatory tool that shapes how manufacturers interact with the FDA from application to approval and beyond.

Whether you’re submitting your first Abbreviated New Drug Application (ANDA) or managing a portfolio of generic products, understanding GDUFA is essential to avoiding costly delays, noncompliance, or operational setbacks. This guide outlines what GDUFA is, who it applies to, the fees involved, and how to stay on track with evolving FDA expectations.

Purpose of GDUFA

GDUFA was enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) in July 2012. It was created in response to mounting challenges in the FDA’s generic drug approval process, which included significant backlogs, inconsistent inspection schedules, and limited agency resources.

The core goals of GDUFA were—and continue to be—multi-dimensional:

• Accelerate patient access to safe, effective, and affordable generic medications
• Improve the predictability and timeliness of FDA’s review process
• Lower industry costs by creating a structured, collaborative framework
• Enhance global oversight through consistent inspections of both domestic and international facilities
• Modernize the FDA’s internal systems and regulatory science tools

At its heart, GDUFA is a contract: the industry funds the FDA’s regulatory efforts through user fees, and in return, the FDA commits to measurable performance improvements.

GDUFA’s Impact on the Pharmaceutical Industry

GDUFA has fundamentally changed how generic drugs are reviewed, approved, and manufactured. It ensures that the FDA has dedicated resources to keep pace with generic drug innovation, while also holding both the agency and manufacturers to higher standards of quality and accountability.

From a business perspective, GDUFA helps generic manufacturers:

• Enter the market faster with reduced approval times
• Better plan for FDA inspections and submissions
• Minimize regulatory unpredictability
• Compete more effectively by aligning with FDA performance targets

And for patients and healthcare systems, GDUFA contributes to lower drug prices and broader access to essential treatments—making it a win for public health.

GDUFA Fee Categorization

Under GDUFA, generic drug manufacturers and related entities are subject to several distinct user fees, each tied to a different business activity or regulatory interaction.

1. ANDA Filing Fee

Charged upon submission of an ANDA, this one-time fee supports the FDA’s scientific and regulatory review of applications. Non-payment results in a Refuse to Receive (RTR) determination.

2. Drug Master File (DMF) Fee

A one-time fee is due when a Type II DMF is referenced for the first time in a generic drug submission. The DMF holder is responsible for the payment, which must be made before the FDA initiates review.

3. Facility Fees

Assessed annually for facilities that manufacture APIs or FDFs, regardless of whether they are based in the U.S. or abroad. Foreign facilities are subject to a foreign differential to account for the cost of international inspections.

Note: If a facility manufactures both API and FDF, only the FDF fee applies.

4. Program Fee

This annual fee applies to ANDA holders and is determined by the number of approved ANDAs:

• Small: 1–5 ANDAs
• Medium: 6–19 ANDAs
• Large: 20+ ANDAs

If multiple entities share ownership, ANDAs may be consolidated under a parent entity for fee calculation.

Facility Inspections Under GDUFA

Inspections are a critical part of GDUFA’s mission to ensure the quality and safety of generic drugs. GDUFA mandates that the FDA apply uniform inspection standards across both domestic and foreign facilities. These inspections evaluate compliance with current Good Manufacturing Practices (cGMP) and verify that manufacturing operations meet the safety, identity, strength, quality, and purity standards set by the FDA.

Under GDUFA III, the FDA is expected to:

• Conduct more predictable and transparent inspections
• Prioritize risk-based inspection schedules
• Collaborate with international agencies to harmonize global inspections
• Use inspection outcomes to inform ANDA approval timelines

Companies must be prepared for both pre-approval inspections (PAIs) and surveillance inspections, with comprehensive Standard of Operating Procedures (SOP), training records, and quality documentation readily available.

GDUFA’s Role in Global Regulatory Alignment

GDUFA also supports the FDA’s efforts to coordinate with global regulatory authorities. Through initiatives like mutual recognition agreements (MRAs) and the International Council for Harmonisation (ICH), the FDA works to reduce duplication in inspections, align technical standards, and share data across borders.

This global collaboration helps ensure consistent oversight, especially as the majority of generic APIs and FDFs are now manufactured outside the United States.

Compliance Under GDUFA is Not Optional, But Strategic

Complying with GDUFA is more than a legal requirement—it’s a strategic investment in market access. Companies that treat GDUFA as part of their operational playbook benefit from:

• Faster approvals and reduced regulatory back-and-forth
• Fewer disruptions from fee disputes or inspection delays
• Stronger internal systems for quality, documentation, and regulatory communication
• Greater investor and partner confidence

Compliance errors, by contrast, carry real costs:

• Missed launch windows
• Public arrears listing by the FDA
• Application holds or outright rejection
• Import refusals and warning letters

GDUFA and Regulatory Science Innovation

GDUFA fees are not just used to process applications—they also fund FDA innovation. Regulatory science initiatives supported by GDUFA include:

• Development of more predictive models for bioequivalence
• Modernization of the FDA’s IT and data systems
• Analytics tools that detect application risks early
• Research to improve complex generic product reviews

These innovations help improve the efficiency and scientific rigor of the entire approval process—benefiting both regulators and manufacturers.

Preparing for GDUFA Success

To proactively manage GDUFA obligations, manufacturers should:

• Maintain a centralized fee tracking system with alerts for each payment cycle
• Review facility registrations annually to ensure correct classifications
• Conduct internal audits of ANDA holdings to assess program fee tier
• Prepare for pre-approval inspections through mock audits and training
• Monitor FDA updates and Federal Register notices related to fee schedules and guidance

How Registrar Corp Helps You Stay Ahead

While GDUFA lays out the rules, it doesn’t offer personalized guidance. That’s where we come in.

Registrar Corp helps clients:

• Track and submit all GDUFA fee payments on time, avoiding penalties
• Maintain visibility across ANDA portfolios and facility registrations
• Interpret changing FDA guidance and inspection protocols
• Prepare for inspections and avoid last-minute panic
• Act as a single point of contact for managing regulatory obligations

In short, we help you move from GDUFA compliance to competitive advantage. Whether you’re new to the U.S. generic market or scaling operations globally, we ensure you’re never caught off guard.

Secure Your Competitive Advantage Through GDUFA Clarity

In the high-stakes generic drug market, compliance clarity is power. GDUFA enables faster access to the U.S. market but only if you understand how to navigate its obligations.

With Registrar Corp you can stay compliant, inspection-ready, and FDA-aligned as we provide the regulatory expertise, strategic support, and operational guidance you need to be market ready. Whether you’re new to GDUFA or managing a growing ANDA portfolio, we’re here to help.

Let Registrar Corp turn your GDUFA compliance into a launch advantage. Contact us today to take the guesswork out of generic drug regulation.