FDA generic drug science and research priorities for 2025
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA).
The FDA determined the priority initiatives in collaboration with industry and the public, including feedback received during the FY 2024 Generic Drug Science and Research Initiatives Public Workshop.
The FY 2025 GDUFA science and research priorities encompass scientific challenges that the generic industry and the FDA’s Generic Drug Program have identified as opportunities to advance the science behind generic drugs. Determining priorities is particularly important for complex products to ensure the program continues its focus on development of innovative methodologies and efficient tools to establish the bioequivalence and quality of generic alternatives.
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