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US FDA Scrutizes Process Risks After Finding Nitrosamines In ARBs

 
• By Bowman Cox

There is a new focus in reviews and inspections where nitrosamines or other dangerous process-related impurities might form.    

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agency grows more cautious about impurities

The US Food and Drug Administration is paying more attention to process-related impurities now that process-related potential carcinogens have been found in certain blood pressure and heart failure medications, says Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.

Even as the agency clamps down on the impurities, called nitrosamines, Woodcock emphasized in a 28 August statement that it is far riskier for patients who need them to...

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