Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)

The Food and Drug Administration (FDA) is announcing a Funding Opportunity Announcement (FOA) for a Cooperative Agreement to support research into and development of practices that will protect the public against nitrosamine risks in human drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities. The award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends. • The proposed work directly supports the U.S. FDA’s stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. • The award recipient will be responsible for assessing how to ensure continued research and development after the FDA funding ends. • The FDA will not accept duplicate or highly overlapping applications under review at the same time.