Center for Research on Complex Generics (U18) Clinical Trials Optional

The Center for Research on Complex Generics (U18) Clinical Trials Optional is a forecasted funding opportunity from the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA). This cooperative agreement is designed to support a central coordinating hub that enhances collaboration between the FDA and the generic drug industry, with a particular emphasis on research pertaining to complex generics. The initiative reflects the FDA’s broader commitment to ensuring access to high-quality, safe, and effective generic drugs and strengthening regulatory science by involving multiple stakeholders, including academia and industry. The primary goals of the Center are multifaceted. It aims to facilitate dialogue with generic drug developers to help surface scientific challenges in development and assessment, allowing the FDA to prioritize research accordingly. The Center will serve as a forum to unite experts from the FDA, academia, and industry, fostering collaboration on projects that contribute to advancing the generic drug landscape. A significant emphasis will be placed on research coordination, particularly for complex generics, a category of generic drugs that often require advanced formulation, delivery systems, or manufacturing processes. Beyond conducting research, the Center is expected to organize scientific workshops, provide specialized training, and disseminate educational materials relevant to generic drug research. All resulting outputs—ranging from academic papers to presentations—will be made publicly accessible to ensure transparency and utility across the sector. The intention is to democratize access to findings and empower the broader community of stakeholders to utilize FDA-funded insights. The cooperative agreement will award one recipient up to $1.5 million, with an identical floor and ceiling value, indicating a fixed budget for the recipient. While no cost-sharing or matching is required, the funded entity is expected to demonstrate the capacity to convene diverse stakeholders, execute rigorous research, and disseminate findings effectively. This funding mechanism allows the FDA to retain substantial involvement in the Center's activities, underscoring its strategic importance. Eligible applicants include a wide array of organizations such as public and private institutions of higher education, nonprofits, for-profit organizations including small businesses, state and local governments, tribal entities, and housing authorities. This broad eligibility supports inclusivity and aims to attract a diverse applicant pool capable of fulfilling the mission. The grant is currently in a forecasted stage, with key dates such as the estimated posting, application due date, and award announcement yet to be determined. Interested parties should monitor Grants.gov and FDA updates closely for the official release. For further inquiries, applicants can contact Terrin Brown at 240-402-7610 or via email at [email protected].