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Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments

Pandemic And Volume Of Work Precluding Timely Assessments

 
• By Joanne S. Eglovitch

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.

3D illustration of Facsimile Metformin bottle on shelf
Manufacturers Complain Of Tight Deadline For Conducting Nitrosamine Risk Assessments • Source: Shutterstock

Some pharmaceutical companies are asking the US Food and Drug Association to give them more time to assess the presence of cancer-causing nitrosamines in new drug products and approved products.

The reasons are varied. For example, Perrigo Company PLC says that internal testing sites have been affected by stay-at-home...

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