Zheng Li
Senior Pharmacologist
Dr. Zheng Li has been a pharmacology/toxicology reviewer in Center of Drug Review and Research (CDER) / FDA for the past eight years. She has been working as an expert in the safety assessment of impurities in drug substance and drug product. Dr. Li serves on the nitrosamine workgroup in CDER to provide expert’s comment on regulatory decisions of nitrosamine drug substance related impurities (NDSRIs). She also serves on CDER genotoxicity subcommittee. Before joining FDA, she worked for EPA in environmental chemical toxicology and risk assessment. Dr. Li is a Diplomate of American Board of Toxicology (DABT).
DAY 2: DECEMBER 5th, 2024
SESSION: Guidance on nitrosamine control from FDA and other regulatory agencies
◆ FDA evaluation of nitrosamine impurities in drug products.
◆ FDA Guidance (updated version): recommended AI limit for NDSRI.
◆ Other regulatory agency guidelines.
