FY 2024 GDUFA Science and Research Report

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 collaborations with research institutions worldwide.

This research 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 alternatives.

Each year, multiple sources of public input help FDA identify specific generic drug science and research priorities that can 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. Eight scientific areas were identified as GDUFA Science and Research Priority Initiatives for Fiscal Year (FY) 2024. Accordingly, this FY 2024 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 research.

 

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