White Paper: Nitrosamines — An Industry Position Paper Based on Risk

The generics industry is committed to taking proactive steps to ensure the quality of generic medicines meets the highest safety standards determined by the FDA. The generics industry is eager to work with FDA to adopt a balanced risk-based approach to addressing the nitrosamine issue. We request the FDA revisit and potentially reassess the set safety limits of the common nitrosamines in pharmaceuticals based on new developments from recent studies, such as consideration for the duration, acute to chronic, use of a product.

The generics industry stands ready to work with the FDA so that we can strike the right balance, that of quality and safety. Further, we stand ready to work with the FDA to mitigate creating or potentially exasperating unintended consequences, such as drug shortages and/or process improvements that are overly burdensome and unsustainable for the FDA and industry, as we refine risk-based approaches to better manage the concerns nitrosamines present.

AAM appreciates the opportunity to share the collective thinking of our member companies on how the generics industry can work with the agency to address the concerns around nitrosamines.

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Association for Accessible Medicines


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