Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and ...
In the summer of 2018, the FDA learned that some generic ARB medications, including valsartan, irbesartan, losartan and others contained nitrosamine impurities— including N-Nitrosodimethylamine (NDMA) ...
The Food and Drug Administration (FDA) has outlined industry guidance for Control of Nitrosamine Impurities in Human Drugs (Rev 1-Feb2021) authorization holders (MAHs) on risk measures to tackle ...
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