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

The Food and Drug Administration’s Center for Drug Evaluation and Research, through its Office of New Drugs, is seeking a cooperative agreement to advance research and practical strategies for identifying and mitigating nitrosamine impurities in human medications. The initiative aims to strengthen public health protections by developing scientifically robust, implementable approaches to detect, evaluate, and control these harmful contaminants while maintaining access to essential therapies. Despite existing regulatory and experimental efforts, significant gaps remain in translating knowledge into widespread industry practices, and this funding seeks to close those gaps through targeted research and innovation. The recipient will also be tasked with designing sustainable mechanisms to ensure ongoing progress in nitrosamine risk mitigation beyond the life of the cooperative agreement. This includes fostering collaboration among pharmaceutical manufacturers, academic institutions, and nonprofit organizations to institutionalize best practices and maintain momentum in safety improvements after federal funding concludes. The effort is guided by the FDA’s mission to safeguard drug safety and is open to applicants through the U01 funding mechanism with point of contact information provided for inquiries.