FY 2025 GDUFA Science and Research Report
FY 2025 GDUFA Science and Research Report (PDF - 11 MB)
What is the GDUFA Science & Research Program?
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) continually advances scientific understanding through research to ensure the safety, effectiveness, and quality of drugs in the United States. A research program established under the Generic Drug User Fee Amendments (GDUFA) since October 2012 helps to ensure that regulatory standards, recommendations, and decisions impacting generic drugs are supported by current scientific insights and modern tools. The GDUFA science and research program is particularly important for complex products because the program supports the development of innovative methodologies and efficient tools to establish the pharmaceutical equivalence, bioequivalence (BE), and quality of generic drugs.
How Does the GDUFA Science & Research Program Protect and Promote Public Health?
The GDUFA-funded research streamlines generic drug development and regulatory assessment. Through targeted research on bioequivalence, manufacturing standards, and quality assurance, the program reduces the time and resources needed to bring high-quality, safe, and effective generic medications to market. This enhanced efficiency delivers two critical public health benefits. First, it makes generic drug development more economically viable for manufacturers, encouraging market competition that reduces drug shortage risks and helps to ensure medication availability. Second, it expands patient access to more affordable treatment options by facilitating availability of lower-cost generic alternatives, removing financial barriers that might otherwise prevent patients from accessing essential medications. The GDUFA science and research program creates a sustainable pathway for generic drug availability, directly supporting FDA's mission to protect and promote public health through safe and effective medications.
What Are the Focus Areas of the GDUFA Science & Research Program?
Each year, multiple sources of public input help FDA identify specific 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 and publishes annual reports describing the corresponding activities and outcomes. Eight scientific areas were identified as GDUFA Science and Research Priority Initiatives for Fiscal Year (FY) 2025.
How is the FY 2025 GDUFA Science & Research Report Organized?
This FY 2025 GDUFA Science and Research report describes active research projects and outcomes in eight chapters corresponding to those eight priority areas for FY 2025, with a ninth chapter that reports on additional generic drug science and research.
Table of Contents
(Each link below will open a 11 MB PDF)
- Introduction
- Joint Directors' Message
- Chapter 1: Impurities
- Chapter 2: Complex APIs
- Chapter 3: Complex Dosage Forms & Formulations
- Chapter 4: Complex Routes of Delivery
- Chapter 5: Drug-Device Combination Products
- Chapter 6: Oral and Parenteral Products
- Chapter 7: Quantitative Methods & Models
- Chapter 8: Data Analytics & Artificial Intelligence
- Chapter 9: Other Generic Product Science & Research
- Acknowledgments
- Appendix: GDUFA Science and Research Outcomes for Fiscal Year 2025
Joint Directors’ Message
The Generic Drug User Fee Amendments (GDUFA) science and research program facilitates patient access to high-quality, safe, and effective generic drugs. This program advances research in areas where generic product development has been limited due to scientific knowledge gaps. GDUFA research outcomes help FDA establish new approaches that can be used by pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop, and make these generic medicines available for patients.
Aligned with the GDUFA Science and Research Priority Initiatives for FY 2025, FDA continued to utilize ongoing external research collaborations and internal scientific excellence to conduct more than 50 research projects that facilitated generic product development and prepared FDA to assess information submitted in abbreviated new drug applications (ANDAs).
The outcomes from GDUFA-funded research expanded our understanding of drug products, including complex products, and contributed to the development of state-of-the-art analytical procedures to characterize product quality and performance. These new analytical procedures provided manufacturers more efficient approaches for developing generic products, and helped FDA better assess the bioequivalence (BE) and quality of complex generic products.
Read the full FY 2025 GDUFA Science and Research Report Joint Directors' Message.