Nitrosamines, Nitrosamines, Nitrosamines…
Monday, October 27, 2025
2:45 p.m. - 4:00 p.m.
This session will address key considerations for controlling Nitrosamine Drug Substance-Related Impurities (NDSRIs), including:
- Timing considerations and potential market impacts
- FDA’s approach to international regulatory alignment
- Industry obligations for notifying FDA when nitrosamine levels exceed the AI (e.g., through FARs, OPQ communications, or DSS notifications)
