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FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products

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 what manufacturers can do...more

Examining the Drug Supply Chain – How the Public Health Emergency Impacts DSCSA

The Drug Supply Chain Security Act was intended to enhance the safety and security of the pharmaceutical distribution supply chain – but in a few short months, everything has changed. Our Food, Drug & Device/FDA Group...more

New Guidance Refines FDA’s Thinking on Data Integrity

Our Food, Drug & Device/FDA Group breaks down the new Food and Drug Administration guidance on data integrity for current good manufacturing practices (CGMPs) and what it means for the drug industry....more

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