FDA announced its FY 2027 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives. The FDA determined the priority initiatives in collaboration with industry and the public, including feedback received during the FY 2026 Generic Drug Science and Research Initiatives Public Workshop.

The FY 2027 GDUFA Science and Research Priorities encompass scientific challenges that the generic industry and the FDA’s Generic Drug Program have identified as critical opportunities to advance the science behind generic drugs. Determining priorities is particularly important for complex products to ensure the program continues its focus on the development of innovative methodologies and efficient tools to establish the bioequivalence and quality of generic drugs.

The FDA publishes these priorities as a part of the agency’s commitment to generic drug development and furthering generic drug science and research. The GDUFA Science and Research Program is vital to the development of product-specific guidances and guidances for industry that can aid generic product development. The agency will continue to track and report on these priority initiatives in FY 2027. [FDA]