Simpler Grants.gov #FOR-FD-24-008

FDA Cooperative Agreement for Research on Nitrosamine Impurities in Drugs

The Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is soliciting applications for a cooperative agreement focused on research into nitrosamine impurities in human drugs. - Government Buyer: - Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) - Products/Services Requested: - Research services to develop and refine translational and implementable practices addressing nitrosamine impurities in human drugs - Evaluation of strategies to sustain research and practice development after FDA funding ends - Eligible Applicants: - Nonprofits, educational institutions, businesses, and government entities - Estimated Award Amount: - $350,000 (no cost sharing or matching required) - Unique/Notable Requirements: - Proposals must be scientifically distinct - Applicants must assess sustainability of research beyond the funding period - No specific OEMs or vendors are mentioned, as this is a research grant opportunity

Description

The Food and Drug Administration's Center for Drug Evaluation and Research is announcing a funding opportunity for a cooperative agreement to support research on nitrosamine impurities in human drugs. The goal is to improve drug safety by developing translational and implementable practices to protect public health from nitrosamine risks while ensuring access to critical therapeutic drugs. The award recipient will also assess how to sustain this research and practice development after FDA funding ends. Eligible applicants include nonprofits, educational institutions, businesses, and government entities.

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