GDUFA, the user fees that pay for generic drug review

On July 30, 2026, FDA published the price of asking it to approve a generic drug in fiscal 2027: $375,684 per application, due when the application is filed and owed whether or not it is ever approved. The Federal Register notice² sets that fee and a dozen others so that generic drug makers will pay the agency a combined $665,986,000 in the year that began Oct. 1, 2026. In fiscal 2018 the same application fee was $171,823, according to that year's notice⁴.

The money comes from the Generic Drug User Fee Amendments, or GDUFA. Industry pays fees, and in exchange FDA commits to review deadlines, inspection coverage and scientific work that makes generics easier to develop. Congress renews the deal every five years, and the current authority runs out in September 2027.

Every generic sold in the US passes through FDA's Office of Generic Drugs, and since 2012 much of that office's work has been funded this way. Knowing what the fees buy explains a lot about how fast new generics reach pharmacy shelves, and why the 2027 renewal matters to anyone who follows generic approvals.

The backlog that started it

By 2012 the generic program was swamped. As of Oct. 1, 2012, the pre-GDUFA backlog "included 2866 ANDAs and 1873 PASs" (prior approval supplements), FDA told Congress in 2016 testimony⁷. The same testimony noted that before 2012 the law set a two-year inspection interval for domestic plants but was silent on how often to inspect foreign ones.

GDUFA was signed into law on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act⁹. Industry agreed to pay about $300 million a year for five years. In return FDA committed to take a first action on 90 percent of the backlog by the end of fiscal 2017, to set review deadlines for new applications and to reach risk-based inspection parity between foreign and domestic sites. How those inspections work is covered in GxRadar's piece on inspections, Form 483s and warning letters.

Approval counts rose as the backlog cleared. In openFDA's Drugs@FDA records¹², original ANDA approvals by calendar year went from 503 in 2012 and 406 in 2013 to 610 in 2016 and 833 in 2017, the highest in the series. They have stayed between 624 and 819 in every full year since, with 575 so far in 2026 (through Oct. 27). Those calendar-year counts differ from FDA's fiscal-year totals in its reports to Congress.

Three rounds so far, a fourth in negotiation

GDUFA II was title III of the FDA Reauthorization Act of 2017¹⁰, the same law that created the competitive generic therapy pathway; its $493.6 million base appears in the FY2018 fee notice⁴. GDUFA III was Division F of Public Law 117-180¹¹, a stopgap spending bill signed on Sept. 30, 2022.

What a generic company pays

Each summer FDA publishes the next year's rates so that total collections hit a statutory target adjusted for inflation. For fiscal 2027, the notice² says program fees supply 36 percent of the $665,986,000 target, ANDA fees 33 percent, finished dosage form and contract manufacturer facility fees 20 percent, active pharmaceutical ingredient (API) facility fees 6 percent and drug master file (DMF) fees 5 percent. The fiscal 2026 column below comes from the July 2025 notice³.

Foreign facilities pay $15,000 more than domestic ones in every facility category. The annual program fee is tiered by how many approved ANDAs a company holds, and the small-business tier is one tenth of the large tier. GDUFA I charged a separate fee for prior approval supplements; the current fee list has none. Facility fees fell slightly for 2027 while the application fee rose 4.9 percent.

What FDA promises in return

The fees come with written performance goals, negotiated with industry and sent to Congress in a commitment letter. Under the GDUFA III letter⁵, FDA agreed to:

• act on 90 percent of standard original ANDAs within 10 months of submission;
• act on 90 percent of priority original ANDAs within 8 months, if the applicant sent complete facility information at least 60 days before filing (otherwise 10 months);
• act on 90 percent of prior approval supplements within 6 months, or 10 months if a preapproval inspection is needed;
• answer 90 percent of controlled correspondence (written technical questions from developers) within 60 days for simpler questions and 120 days for harder ones;
• publish product-specific guidance for 50 percent of complex brand products approved on or after Oct. 1, 2022, within two years, and 75 percent within three.

An action can be an approval, a tentative approval (the product meets the science but patents or exclusivities still block sale; see Paragraph IV certifications) or a complete response letter listing deficiencies. Hitting a goal date does not mean the application was approved.

FDA reports results each year. For original ANDAs received in fiscal 2023, the FY2025 performance report⁶ shows action within the goal date on 92 percent of standard applications and 88 percent of priority ones. Counting approvals made within 60 days after the goal date, which the commitment letter treats as on time when an action is imminent, the figures rise to 94 percent and 93 percent, and FDA says it met the goals for that cohort. In fiscal 2025 the agency approved 689 ANDAs and tentatively approved 250 more.

Where the money goes

User fees pay for reviewers, inspections, information systems and a research program on generic drug science. That research feeds product-specific guidances, which tell developers what studies FDA expects for a particular drug; FDA had published 2,288 of them by Sept. 30, 2025, the same report⁶ says. It credits the research with making generics of certain complex topical products feasible after years in which they were "practically unfeasible to develop." GxRadar's explainer on complex generics covers that work.

Inspections are a large line item. In fiscal 2025 FDA ran 182 surveillance inspections of API facilities tied to generic applications, 152 of them outside the US, and 218 surveillance inspections of finished dosage form facilities, according to inspection tables in the FY2025 performance report⁶.

Fees do not change the legal standard. A generic still has to match the brand in active ingredient, strength, dosage form and route, and perform the same way in the body, as GxRadar's guide to how a generic drug gets approved explains. GDUFA buys staffing and predictability; the approval decision stays with FDA.

GDUFA IV and the September 2027 deadline

FDA's GDUFA IV page⁸ says the current authority expires in September 2027 and that "new legislation will be required" for the agency to keep collecting generic drug user fees after that. FDA opened the process with a public meeting on July 11, 2025, held negotiation sessions with industry from Oct. 22, 2025, through March 27, 2026, and has posted a proposed commitment letter for fiscal years 2028 through 2032. FDA scheduled a public meeting on the package for Sept. 17, 2026. The last step belongs to Congress, which usually folds the generic, brand, biosimilar and device user fee renewals into one bill; FDA's main GDUFA page¹ tracks the program's status.