Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
FDA grant seeks research to reduce nitrosamine impurities in drugs, ensuring public safety and continued access to needed medications, with a plan for sustained research.
Funder: Food and Drug Administration
Due Dates: Forecasted (no current deadline posted)
Funding Amounts: $350,000 (single award; cooperative agreement)
Summary: Supports research to identify, evaluate, and implement approaches to reduce nitrosamine impurities in drugs, improving public safety and ensuring continued access to essential medications.
Key Information: This is a forecasted opportunity; application details and deadlines are not yet posted.
Description
The Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing a cooperative agreement to support research addressing nitrosamine impurities in human drugs. The initiative aims to protect public health by developing and refining translational and implementable practices that mitigate unacceptable risks from nitrosamine impurities, while ensuring continued safe access to critical therapeutic drugs.
The awardee will not only conduct research and develop best practices but also assess strategies to sustain these efforts among industry, non-profits, and academic institutions after the conclusion of FDA funding.
