Quality Lowdown: FDA Defends Nitrosamine Testing Methods While US, EU Enforcement Continues
The crisis of nitrosamine contamination in prescription drug products continues to roil the world’s health authorities and prompts debate on the different approaches used to measure these impurities. Meanwhile, an Austrian firm gets inspected despite the pandemic and yet another homeopathic firm gets an FDA warning letter.
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The USP has launched an initiative to address the nitrosamine crisis by proposing a new general chapter that outlines a set of analytical methods that manufacturers can use to demonstrate their products are free from unsafe levels of these potential carcinogens. The chapter is aligned with the FDA’s guidance on nitrosamine impurities.
Regulators whipsawed by COVID-19-related drug shortages are seeking better ways to forecast demand.
Headlines about potential carcinogens in the drug supply have been a chronic, low-level challenge for the US FDA’s reputation in recent years. A recent Congressional hearing shows how much tinder is now laid for a potential flare up into a full-on crisis in confidence in the agency.