Center for Research on Complex Generics (U18) Clinical Trials Optional
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The Food and Drug Administration is establishing a Center for Research on Complex Generics through a cooperative agreement to advance the development and evaluation of complex generic drugs. The center will serve as a central hub to strengthen collaboration between the FDA and the generic drug industry, academic experts, and other stakeholders by identifying key scientific challenges in generic product development and guiding priority research areas. It will facilitate ongoing engagement with industry associations and companies to ensure that regulatory science efforts align with real-world barriers to market entry for generics. The center will coordinate and conduct research projects focused specifically on complex generics, host scientific workshops and training programs, and create a platform for interdisciplinary collaboration among FDA scientists, academics, and industry representatives. A core commitment is to ensure that all research outputs—including scientific articles, posters, presentations, and other resources—are made freely and openly available to the public. This initiative is designed to enhance patient access to safe, high-quality generic drugs by bridging scientific gaps and accelerating innovation in the generic drug sector, while complementing the FDA’s broader regulatory science initiatives.
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Agency
NAICS
Place of Performance
Not specifiedSet-Aside
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Full Description
The Food and Drug Administration (FDA) seeks to fund a Center for Research on Complex Generics under the terms and conditions of a cooperative agreement. The Center for Research on Complex Generics will support the FDA's efforts to enhance collaborations with the generic drug industry relating to generic drug research, to further the FDA's mission of increasing patient access to high quality, safe, and effective generic drugs.
The goals of a Center for Research on Complex Generics include:
1) Facilitating engagement with generic industry representatives to help identify scientific challenges for generic product development or assessment, and helping to inform FDA about priority areas for research to address these challenges by supporting engagement and coordination between the FDA and key generic industry industry associations, companies, and representatives.
2) Providing a forum for experts from FDA, academia, the generic drug industry, and elsewhere to collaborate on research related to generic products.
3) Coordinating and conducting research projects pertaining to generic products, particularly complex generics.
4) Hosting scientific workshops, providing training, and supporting other educational activities pertaining to generic drug research.
5) Providing free and open public access to generic drug research outcomes such as scientific articles, posters, presentations, and other resources that help the generic drug industry to leverage scientific insights from FDA funded generic drug research.
The Center for Research on Complex Generics is expected to complement FDA's existing regulatory science programs through its specific focus as a hub for coordination and engagement between FDA and the public, including academic experts, generic industry representatives, and other stakeholders.
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