Center for Research on Complex Generics (U18) Clinical Trials Optional
FDA grant to fund a center researching complex generics, fostering collaboration between the FDA, industry, academia, and the public to improve access to generic drugs.
Funder: Food and Drug Administration
Due Dates: Forecasted; estimated post and due dates not yet announced
Funding Amounts: $1,500,000 (single award; cooperative agreement; project period and duration not specified)
Summary: Supports a center to advance research, collaboration, and public access in the field of complex generic drugs, enhancing FDA-industry-academia engagement.
Key Information: 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.
