Simpler Grants.gov #RFA-FD-27-001

FDA Cooperative Agreement for Collaborative Research on Complex Generics

The U.S. Food and Drug Administration is seeking a research partner to advance the development and assessment of complex generic medicines. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). - Opportunity: One cooperative agreement is anticipated for collaborative research on complex generics. - Research focus: Identify scientific challenges in developing and assessing complex generics, support research relevant to drug development and regulatory review, and translate findings into scalable industry best practices that can help expand access to affordable medicines. - Eligible applicant: The University of Maryland is the only eligible applicant identified. - Funding: Up to $2 million for the first project year; later annual budgets are capped at $2.5 million. Funding is contingent on appropriations, availability, and satisfactory performance. - Duration: Up to five years, with one initial year and up to four additional years of recommended support. - OEMs and commercial vendors: None identified. No physical products, part numbers, or product quantities are requested.

Description

The FDA seeks to expand access to high-quality, safe, and effective generic medicines and reduce drug-shortage risk through a more competitive, multi-sourced generic drug market. The opportunity supports collaborative research into scientific challenges in complex generic product development and assessment, with emphasis on development and regulatory review. It also aims to translate research findings into industry best practices and expand access to affordable complex generics. Only the University of Maryland is eligible to apply; one award is anticipated, with a maximum project period of five years.

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