GDUFA User Fees: Generic Drug User Fee Amendments Explained

GDUFA User Fees: Generic Drug User Fee Amendments Explained

Key Takeaways

What Is GDUFA? Legislative History and Purpose

Legislative Timeline

Why GDUFA Was Needed

Before GDUFA, the generic drug review program was funded entirely through congressional appropriations. By 2012, the ANDA backlog had grown to approximately 2,800 pending applications, with median review times exceeding 30 months. The backlog delayed generic drug competition and kept drug prices elevated.

GDUFA provided dedicated funding that allowed OGD to:

• Hire hundreds of additional reviewers
• Implement standardized review processes
• Create the pre-ANDA meeting program
• Develop product-specific guidances
• Reduce the ANDA backlog significantly

GDUFA III Fee Types and Current Amounts

GDUFA III establishes four categories of user fees. Fee amounts are adjusted annually by FDA based on a formula that accounts for inflation and workload.

Fee Structure Overview (FDA FY2026 Published Rates)

ANDA Application Fee

The ANDA application fee is a one-time fee paid at the time of original ANDA submission. Key details:

• Required for: Every original ANDA submitted to FDA
• Not required for: Supplements and annual reports
• Payment method: Pay.gov electronic payment
• Consequence of non-payment: Refuse-to-receive; ANDA will not be filed
• Refund policy: No refund if ANDA is refused to receive, withdrawn, or receives a complete response letter

GDUFA III does not use a separate PAS fee category in the way this article previously suggested. The core fee categories are ANDA, DMF, facility, and program fees.

Drug Master File (DMF) Fee

The DMF fee is a one-time fee paid when a Type II Drug Master File is first submitted to FDA or when a DMF that was previously incomplete is reactivated.

• Required for: Type II DMFs (drug substance, drug substance intermediate, and drug product) that are referenced in pending or approved ANDAs
• Not required for: Type III DMFs (packaging materials), Type IV DMFs (excipients), or Type V DMFs (FDA-accepted reference information)
• Consequence of non-payment: DMF may be placed on "not available for reference" status
• Timing: Must be paid before the DMF can be referenced in an ANDA

Facility Fees

Facility fees are annual fees assessed on manufacturing establishments that are identified in at least one approved or pending ANDA or DMF.

Finished Dosage Form (FDF) Facility Fee:

• Assessed on each facility identified as a manufacturer, repacker, relabeler, or testing site in an approved or pending ANDA
• One fee per facility regardless of how many ANDAs reference the facility
• Applies to both domestic and foreign facilities

API Facility Fee:

• Assessed on each facility identified as an API manufacturer in a DMF referenced by an approved or pending ANDA
• Separate domestic and foreign rates apply

CMO Facility Fee:

• Separate domestic and foreign CMO rates apply to qualifying contract manufacturing organizations under the statute and FDA's annual fee notice

GDUFA III Performance Goals and Review Timelines

In exchange for user fees, FDA commits to specific performance goals for ANDA review. These commitments are documented in the GDUFA III Commitment Letter, available on FDA.gov.

Review Timeline Goals

What "Action" Means Under GDUFA

An FDA "action" on an ANDA includes any of the following:

• Approval (effective)
• Tentative approval
• Complete response letter (CRL)
• Refuse to receive

All of these count as meeting the GDUFA goal date. This means that a CRL issued within the 10-month goal counts as timely action, even though the ANDA is not approved.

Priority Review Under GDUFA III

GDUFA III provides for 8-month priority review for ANDAs that meet certain criteria:

The Pre-ANDA Program Under GDUFA III

GDUFA III significantly expanded the pre-ANDA program, providing generic drug applicants with opportunities to engage with OGD before filing an ANDA.

Pre-ANDA Meeting Types

Pre-ANDA Facilitated Meetings

GDUFA III introduced a streamlined pathway for product-specific questions through facilitated meetings:

• Written response only: OGD provides a written response without a face-to-face meeting
• Faster turnaround: Targeted at 90 calendar days for response
• Focused scope: Specific product development questions tied to product-specific guidances
• No meeting package required: Simplified submission format compared to formal meetings

When to Use Pre-ANDA Meetings

Controlled Correspondence Program

In addition to formal pre-ANDA meetings, GDUFA III continues the controlled correspondence program for less complex questions.

What Is Controlled Correspondence?

Controlled correspondence allows ANDA applicants to submit specific scientific or regulatory questions to OGD outside the formal meeting process.

Appropriate for controlled correspondence:

• Questions about an existing product-specific guidance
• Clarification on a specific regulatory requirement
• Questions about BE study design for products with published PSGs
• Questions about sameness determinations (active ingredient, dosage form)

Not appropriate for controlled correspondence:

• Questions requiring a comprehensive product development discussion (use meeting instead)
• Questions about multiple topics (one topic per correspondence)
• Questions where no PSG exists (use Product Development Meeting instead)

Response timeline: GDUFA III goal is a written response within 60 days for controlled correspondence.

Fee Waivers and Reductions

GDUFA contains limited statutory waiver and reduction provisions, but they are narrower than the broad small-business framework used in some other FDA user-fee programs. Applicants should verify current waiver eligibility directly against the statute, FDA's fee pages, and the current Federal Register notice before budgeting or filing.

ANDA Application Fee Waivers

This article does not restate detailed waiver thresholds because they are easy to misstate and can change with the governing statute and FDA implementation materials.

Facility Fee Adjustments

• Domestic and foreign facility rates are different under FDA's FY 2026 fee notice
• CMO facilities use separate fee categories from standard API and FDF facilities

How to Request a Fee Waiver

1. Review the current GDUFA statute and FDA user-fee pages.
2. Confirm whether the specific fee category has a statutory waiver or reduction provision.
3. Follow FDA's current submission instructions for any waiver request.
4. Do not assume that a waiver exists simply because a similar program offers one.

GDUFA Fees vs. PDUFA Fees: A Comparison

Understanding how GDUFA fees compare to PDUFA (Prescription Drug User Fee Act) fees for branded drugs puts the generic drug fee landscape in context.

The substantially lower GDUFA application fee relative to PDUFA reflects the differences in review complexity and development costs between generic and innovator drugs.

How GDUFA Fees Fund FDA Operations

GDUFA fees are dedicated to generic drug review activities within CDER's Office of Generic Drugs and supporting offices. Fee revenue funds:

Staffing and Capacity

Program Enhancements Under GDUFA III

GDUFA III directed fee revenue toward several program improvements:

• Complex generics development: Expanded regulatory science research for difficult-to-develop generics (injectables, ophthalmic, topical, complex APIs)
• Pre-ANDA program expansion: More meeting slots and faster turnaround times
• Product-specific guidance development: Increased PSG publication rate (target: 300+ PSGs per year)
• Inspection modernization: Risk-based inspection scheduling, mutual recognition with foreign regulators

Annual Fee Adjustment Process

GDUFA fees are not fixed. FDA adjusts fee amounts annually using a formula specified in the statute.

How Fees Are Calculated

Annual Fee Publication

• FDA publishes proposed fee amounts in the Federal Register each year (typically in June-July)
• Final fee amounts are published before October 1 (start of federal fiscal year)
• Industry has an opportunity to comment on proposed fees
• Fee amounts take effect on October 1 each year

Practical Planning: GDUFA Fees in Your Regulatory Budget

Generic drug companies should account for GDUFA fees in their product development budgets:

Per-Product Fee Estimation

Illustrative domestic example for 1 ANDA + 1 Type II DMF + 1 domestic FDF facility + 1 domestic API facility:

• Year 1 total: $743,323 before any program fee
• Annual ongoing: $282,492 in domestic facility fees, plus any applicable program fee

Annual burden increases materially when foreign facilities or annual program fees apply, so portfolio-level budgeting should be built from the current FDA fee schedule rather than fixed rules of thumb.

References