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Perrigo Among Firms Requesting Delay In Conducting US Nitrosamine Risk Assessments

 
• By Joanne S. Eglovitch

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.

After OTC and Rx drugs containing ranitidine and other ingredients were linked to nitrosamine, firms marketing drugs in the US have until 1 March to test for impurity risks from the potential carcinogenic associated with chemically synthesized APIs and all approved drugs that contain those APIs.

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

Their reasons are varied. For example, Perrigo Company PLC says internal testing sites have been affected by stay-at-home orders caused by the COVID-19 pandemic, and that actions such as these orders limit ability to conduct tests and risk assessment

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More from Policy & Regulation

Stakeholders Hope US FDA’s Proposed Animal Test Phase-Out For Drugs Will Extend To OTCs, Cosmetics

 
• By Eileen Francis and Lauren Nardella

The US Food and Drug Administration has released a roadmap to adopt new approach methodologies in lieu of animal testing for monoclonal antibody therapies and other drugs, which may include OTC drugs though the proposal does not specifically include cosmetics.

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Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”