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.
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.
