Perrigo Among Firms Requesting Delay In Conducting US Nitrosamine Risk Assessments
Perrigo, Pfizer want FDA to postpone its March deadline for conducting nitrosamine risk assessments. Generics executive cites “serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
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Revision to FDA's September 2020 guidance on assessing nitrosamine impurity risks associated with all chemically synthesized APIs and all approved drug products that contain those APIs doesn’t satisfy industry stakeholders.
Draft guidance on testing investigational drugs for drug-drug interactions with ingredients used in antacids, histamine H2-receptor antagonists and proton pump inhibitors points to including labels warnings on the new drugs about their concomitant use with the heartburn remedies.
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.