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Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments

Pandemic And Volume Of Work Precluding Timely Assessments

Executive Summary

Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec 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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