Date:
October 15 - 16, 2024
Day1:
Tue, Oct 15 8:00 AM - 5:00 PM ET
Day2:
Wed, Oct 16 8:00 AM - 4:00 PM ET
Location:
FDA White Oak Campus, Room 2031, Building 2. 10903 New Hampshire Avenue, Silver Spring.
Goals and Objectives:
- To provide a forum for open discussion between regulators and industry on the data generated using enhanced Ames assay methodologies to assess the mutagenic potential of nitrosamines.
- Present and hold open discussions on specific questions related to the generated data.
- Discuss recommendations on the relevant and most predictive test conditions of the Ames test for more reliable prediction of the mutagenic potential of nitrosamines.
- Discuss the correlation of Ames assay results for nitrosamine drug substance related impurities (NDSRIs) and in vivo carcinogenicity/mutagenicity.
- Generate recommendations for publication in a scientific journal and make them publicly available.