FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)
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FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)
Regulatory Affairs Pharma & Biotech
Tuesday, 01 July 2025
Pablo Palomar, Senior Toxicology Officer at QbD Group
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On June 23, 2025, the FDA released a clarification regarding the upcoming August 1, 2025 deadline related to nitrosamine drug substance-related impurities (NDSRIs).
FDA Deadline Update - Risk of nitrosamine drug substance-related impurity
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Key takeaways from the update:
- Confirmatory testing and risk evaluation must still be completed by August 1, 2025. This deadline remains unchanged.
- CMC changes: While previously expected by the same date, the FDA now acknowledges that many mitigation strategies may require more time. If companies cannot submit full changes by August 1, they are now required to submit a progress update instead. Progress update should include specific content as outlined in the recommendations published by the FDA update. This ensures transparency and accountability while allowing more time for complex implementation work.
What's next?
After reviewing the submitted progress updates, the FDA will provide a revised targeted timeline for full implementation.
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