FDA's generic drug science and research program

In fiscal 2025, FDA counted 153 generic drug approvals that research paid for by generic drug user fees had "impacted," according to the appendix of the agency's FY 2025 GDUFA Science and Research Report¹. The same year, by FDA's own notice, "No new grants or contracts for research were awarded³." That year's research priorities were addressed entirely through grants and contracts awarded in earlier years that received continuation funding.

The program gets little attention outside the industry, but it shapes what reaches the pharmacy shelf. Its findings feed the product-specific guidances that tell generic makers which studies FDA expects for each drug, and for complex products such as inhalers, injectables and skin patches, those recommendations often decide whether a generic is feasible at all.

This piece explains where the program came from, how FDA sets its research list each year, how results turn into guidance, and what FDA's annual scorecards do and do not show.

Where the program came from

A research program has been part of the generic drug user fee system since October 2012, when the first Generic Drug User Fee Amendments took effect, FDA says on its FY 2025 report page². The work is run by the Office of Research and Standards⁷ inside FDA's Office of Generic Drugs, which GxRadar profiles in a separate piece.

Today's rules sit in the GDUFA III commitment letter⁹ covering fiscal 2023 to 2027. In it, FDA promised four things: to "conduct internal and external research" supporting its review and pre-submission commitments; to hold a public workshop every year and post an annual list of research initiatives; to meet twice a year with an industry regulatory science working group if one forms, and post the minutes; and to report each year on how research-funded projects support generic development, timely approval and "new approaches to evaluate generic drug equivalence." More on the fee system itself is in GxRadar's explainer on GDUFA.

How the yearly research list is set

Each spring or early summer, FDA holds a public workshop and takes comments on what the next year's research should cover. The most recent, on June 8 and 9, 2026⁸, invited input from "the generic drug industry, academia, patient advocates, professional societies, and other interested parties." FDA used it to write the fiscal 2027 priority list⁴, posted on the agency's research priorities page⁵ alongside every list back to fiscal 2013.

FDA's fiscal 2027 list has eight areas. FDA says the numbering "does not reflect any relative prioritization."

Nitrosamines lead the list for a reason. FDA's limits on these impurities have led to recalls and reformulation work on older generics, a story GxRadar told in its nitrosamine explainer.

From research to product-specific guidance

Most research reaches industry as guidance. "FDA's recommendations related to BE and product quality are communicated to the generic drug industry largely through the continual publication of new and revised product-specific guidances," the office directors wrote in the FY 2025 report. In fiscal 2025, FDA issued 925 product-specific guidances, 49 of them for complex products.

Most of that volume came in one day. On Oct. 31, 2024, the first day of fiscal 2025, FDA published 814 revised draft guidances for immediate-release oral drugs, announced in a Federal Register notice¹⁰. They aligned FDA's advice with ICH M13A¹¹, which FDA's report calls the first ICH guideline written specifically for generic drug bioequivalence. FDA's Drug Competition Action Plan page¹² says the revisions recommend a single study, fasting or fed, for products without a high food-effect risk, "rather than conducting two BE studies."

For complex products, the payoff is slower and more visible. FDA credits its inhaler research as "the reason that most PSGs on OINDPs [orally inhaled and nasal drug products] now include recommendation for an option to demonstrate bioequivalence (BE) that is more efficient than conducting a comparative clinical endpoint (CCEP) BE study." GxRadar explains that approach in its piece on generic inhalers. The report also ties peptide characterization research to the first generic liraglutide injection, approved Dec. 23, 2024, and nanomaterial research to generic amphotericin B liposome, paclitaxel protein-bound particle and iron sucrose approvals in fiscal 2025.

What the annual reports count

Since GDUFA II, FDA has published an outcomes table with each annual report, split into three categories: research supporting product development, research supporting the evidence in applications, and research on equivalence methods. The table below pulls selected rows from the FY 2025 appendix⁶, which restates every year since fiscal 2018.

In the table, approvals and submissions come from FDA's "evidence" category, and the other three columns from its "development" category. FDA notes that fiscal 2018 figures were recalculated and fiscal 2021 figures corrected. These are FDA's own tallies of where research "impacted" a decision, a judgment the agency makes itself, and a single approval can draw on several projects.

For scale, GxRadar's analysis of openFDA's Drugs@FDA data¹⁶ counts between 624 and 833 original generic approvals in each calendar year from 2017 through 2025. Those are calendar years and FDA's table uses fiscal years, so the two do not divide neatly. The yearly series is on GxRadar's approvals tracker.

Who does the work, and what comes next

FDA ran "more than 50 research projects" in fiscal 2025 using both its own laboratories and outside grantees and contractors, according to the report. A grant-funded Center for Research on Complex Generics hosted five scientific workshops that year. The 2026 workshop calendar⁷ included sessions on transdermal and topical bioequivalence on Sept. 10, the GLP-1 generic pathway on Sept. 23 and 24, and inhalation bioequivalence on Oct. 14 and 15¹³. FDA lists its guidances on skin-patch adhesion and irritation testing, covered in GxRadar's patch explainer, among the notable guidances that grew out of this research.

The program's legal footing expires with GDUFA III in September 2027, FDA's reauthorization page¹⁴ says. The proposed GDUFA IV commitment letter¹⁵ for fiscal 2028 to 2032 carries the same four research commitments forward almost word for word. Without new legislation, FDA says, it cannot keep collecting generic drug user fees after GDUFA III lapses.