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US FDA’s 30-Day Extension For Nitrosamine Assessments Short Of Industry Recommendation

 
• By Malcolm Spicer

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.

Manufacturers of chemically synthesized active pharmaceutical ingredients and finished products containing those APIs marketed in the US, including OTC heartburn remedies with ranitidine, have an additional 30 days to test for the presence of cancer-causing nitrosamines.

The Food and Drug Administration’s publication on 24 February of a revision to its September 2020

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