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Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication

Executive Summary

Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.

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US FDA Postmarketing Drug Safety Modernization Plan Will Cut Across Review Disciplines

Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.

EU Regulators Prioritize Nitrosamine Evaluations Deadline

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

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