On May 1, 2025, the FDA’s Center for Drug Evaluation and Research published its fiscal year 2024 (FY24) Generic Drug User Fee Amendments (GDUFA) Science and Research Report.
Each year, with public input, FDA identifies generic drug science and research priorities that can help expand and accelerate patient access to generic drugs. FDA then advances research in those scientific areas through extensive collaborations among FDA scientists, as well as through collaborations with research institutions around the world.
For example, an insufficient scientific understanding can create uncertainty about how to develop a complex generic product, or how to demonstrate that it is bioequivalent to its brand name reference listed drug product. GDUFA research outcomes help FDA establish efficient new approaches that can be used by pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop, thus making more safe, effective, and high-quality generic medicines available for patients.
The GDUFA science and research program fosters early engagement between FDA and industry to identify specific priority areas for GDUFA research. The program also facilitates continued engagement through pre-ANDA meetings during product development to discuss how insights from GDUFA research can be leveraged. The report published today describes how the GDUFA science and research program is an essential component of FDA’s mission to protect and promote public health.