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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