Generic drug industry pushes FDA to address nitrosamine impurities in a new way
In Feb. 2021, the FDA called on all drug manufacturers to improve the safety of the US drug supply and conduct risk assessments of all approved or marketed products to detect potentially cancer-causing nitrosamine impurities.
The across-the-board call to action followed several recalls for high-profile drugs like the heartburn med Zantac and the type 2 diabetes drug metformin. While the FDA had initially called for these risk assessments to be done by March 31, 2021, generic drug manufacturers are now coming back to the agency, more than a year later, explaining why this will likely be a years-long, rather than months-long, process.
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