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US FDA Invites Public Input on N-nitrosamine Drug Substance Impurities in Drug Development and Regulatory Evaluation


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The U.S. Food and Drug Administration (FDA) is seeking public input regarding the identification, assessment, and management of N-nitrosamine drug substance-related impurities (NDSRIs) during drug product development and regulatory evaluation. The deadline for submitting public comments is July 3, 2023.

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