Manufacturers, industry groups comment on FDA’s control over nitrosamines in drug products
The FDA has received comments from manufacturers and other industry players on how best to tackle impurities known as nitrosamines in drugs.
In May, the FDA sought out comments from manufacturers and other stakeholders on how best to deal with the potentially cancer-causing substances after it previously issued guidance. The regulator published the comments earlier this month.
The FDA first began investigating nitrosamines in 2018 over concerns about impurities in the blood-pressure drug valsartan. It then put out guidance for manufacturers in 2020 that required them to conduct risk assessments of all approved or marketed products to detect potentially cancer-causing nitrosamine impurities and ensure that their products have acceptable levels of the impurities.
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