FDA’s Center for Drug Evaluation and Research published its Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Report.
The GDUFA Science and Research Program supports the development of safe, effective, and high-quality generic drugs for Americans through research and development of innovative methodologies and more efficient tools for demonstrating generic drug product quality and equivalence. The research focuses on overcoming scientific challenges for generic product development in the areas that FDA—working collaboratively with the generic drug industry, academia, and other stakeholders—identifies to be priorities each fiscal year.
This report summarizes the program’s progress and highlights the research outcomes for the 13 research priority topic areas for FY 2022. The report also includes information on eight new research contracts and seven new grants (not including supplements to existing projects) that FDA awarded for innovative generic drug-related extramural research projects, as well as more than 70 intramural research projects to improve generic drug development and regulatory assessment.