FDA Flags Nitrosamine Impurity Risk in Combination Products

The U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), has issued a formal communication to manufacturers of CDRH-led combination products, highlighting the nitrosamine impurity risk and outlining regulatory expectations for risk identification, mitigation, and ongoing monitoring. The move underscores increasing regulatory scrutiny on drug-device combination products, particularly those […]

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