FY 2023 GDUFA Science and Research Report
FY 2023 GDUFA Science and Research Report (PDF - 19 MB)
FDA’s generic drug Science and Research Program created under the Generic Drug User Fee Amendments (GDUFA) is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research collaborations among FDA scientists and through multiple collaborations with research institutions worldwide.
GDUFA-funded research aims to improve the efficiency with which generic drugs can be developed and assessed, and benefits public health in two critical ways:
- making it more feasible for manufacturers to develop generic drugs, which can reduce the risk of drug shortages and facilitates competition; and
- enhancing patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need.
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 reports that correspond to these activities and their outcomes. In FY 2023 eight scientific areas were identified as GDUFA Science and Research Priority Initiatives. Accordingly, this FY 2023 GDUFA Science and Research report describes active research projects and outcomes organized into eight chapters corresponding to the eight priority areas with a ninth chapter reporting on additional generic drug
Table of Contents
(Each link below will open a 19 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
Joint Directors’ Message
The GDUFA science and research program facilitates patient access to high-quality, safe, and effective generic drugs. It does this by advancing research in areas where generic product development has been limited due to scientific knowledge gaps. 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. Each fiscal year, experts across the generic drug industry collaborate with FDA to establish research priorities for the most pressing scientific challenges they face with generic product development. Scientists and clinicians from industry, academia, and the FDA then strategically design research projects and studies so that the research outcomes enable FDA to build scientific bridges across the knowledge gaps. The outcomes of this research help FDA establish efficient new approaches for pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop, thus making these generic medicines available for patients.
Read the full FY 2023 GDUFA Science and Research Report Joint Directors' Message.