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AAM Urges FDA To Reassess Nitrosamines

Generics Industry Body Proposes Science-Driven, Risk-Based Approach

Executive Summary

The AAM has published a position paper on nitrosamines that urges the FDA to revisit and reassess its safety limits for nitrosamines in pharmaceuticals, while also proposing a “science-driven” risk-based approach to evaluate drugs for the potential presence of nitrosamines.

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