Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
The FDA (CDER/OND) is seeking cooperative agreement projects to identify and evaluate approaches to reduce and manage nitrosamine impurities in human drugs. The work should translate into implementable practices that protect patients from nitrosamine-related risks while maintaining safe access to critical therapies. A key added requirement is assessing how these practices can continue being ad…
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