[Food and Drug Administration](https://www.fda.gov/)

Forecasted; estimated post and due dates not yet announced

$1,500,000 (single award; cooperative agreement; project period and duration not specified)

Supports a center to advance research, collaboration, and public access in the field of complex generic drugs, enhancing FDA-industry-academia engagement.

Clinical trials are optional; only one award is expected.

--- ## Description The Food and Drug Administration (FDA) is forecasting a cooperative agreement to establish a Center for Research on Complex Generics. The Center will serve as a hub for research, collaboration, and engagement among the FDA, academia, the generic drug industry, and the public. Its primary aim is to address scientific challenges in the development and assessment of complex generic drugs, ultimately supporting the FDA’s mission to increase patient access to high-quality, safe, and effective generics. Key goals of the Center include: - Facilitating engagement with generic industry representatives to identify and prioritize scientific challenges in generic product development and assessment. - Providing a collaborative forum for experts from the FDA, academia, and industry to advance research on generic products, especially complex generics. - Coordinating and conducting research projects related to generic drugs. - Hosting scientific workshops, training, and educational activities to build capacity in generic drug research. - Ensuring free and open public access to research outcomes, including articles, posters, presentations, and other resources. The Center is expected to complement existing FDA regulatory science programs by focusing on coordination and engagement with external stakeholders. --- ## Due Dates - This is a forecasted opportunity; estimated post and application due dates have not yet been announced. - Researchers should monitor [Grants.gov](https://www.grants.gov/search-results-detail/356044) for updates. --- ## Funding Amount - Total funding: $1,500,000 (award ceiling and floor are both $1,500,000). - Only one award is expected. - Funding instrument: Cooperative Agreement. - Project period and duration are not specified in the forecast. --- ## Eligibility Eligible applicants include: - State, county, city, or township governments - Special district governments - Independent school districts - Public and state-controlled institutions of higher education - Private institutions of higher education - Native American tribal governments (federally recognized and other tribal organizations) - Public housing authorities/Indian housing authorities - Nonprofits with or without 501(c)(3) status (other than institutions of higher education) - For-profit organizations (including small businesses) - Unrestricted (open to any type of entity listed above) There are no cost sharing or matching requirements. --- ## Application Process - This is a forecasted opportunity; the application package and instructions will be available once the opportunity is officially posted. - Monitor the [official Grants.gov listing](https://www.grants.gov/search-results-detail/356044) for updates, application materials, and deadlines. - Prepare to demonstrate capacity for multi-stakeholder engagement, research coordination, and dissemination of research outcomes. --- ## Additional Information - Clinical trials are optional under this opportunity. - The Center is expected to provide open access to research outputs and actively engage with the generic drug industry and academic community. - Only one award will be made, so competition is expected to be significant. --- ## External Links - [FDA Home Page](https://www.fda.gov/) - [Official Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/356044) --- ## Contact Information | Name | Role | Email | Phone | |--------------|---------|-----------------------------------------|---------------| | Terrin Brown | Grantor | [terrin.brown@fda.hhs.gov](mailto:terrin.brown@fda.hhs.gov) | 240-402-7610 | | FDA General | | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888)-463-6332 |

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

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