Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the International Harmonization topic
No spam. Unsubscribe anytime.
FDA acknowledges data gaps, seeks harmonization on nitrosamine assessment
Summary
The presenter said FDA is actively assessing new data, noted discordant results in the literature, and described participation in international working groups and ICH M7 addenda to harmonize nitrosamine assessment.
The presenter told attendees that FDA participates in international groups (including a joint technology working group and the ICH M7 nitrosamine addendum) and collaborates with external research partners to advance nitrosamine science and harmonize approaches across regulators.
"FDA formed partnership with Health and Environmental Science Institute has actively contribute to advancing nitrosamine science," the presenter said, and added that although FDA proposed recommendations in 2023, information was limited at that time and uncertainties remain. The presenter acknowledged that data gaps and discordant findings persist and said the agency is actively assessing new data and working with other regulators toward harmonization.
The official asked applicants to monitor FDA's nitrosamine webpage for updates and to use the agency's product-specific communication pathways when they need guidance on particular products.
