Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control
FDA Law Blog: Biosimilars
SEPTEMBER 11, 2024
One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API), making them difficult to detect. The revisions due in 2025 include testing for NDSRIs.
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