Navigating the Whirlwind Surrounding N-Nitrosamine Impurities in APIs and Drug Products

FDA Practice Group Leader David Rosen is speaking in SAAMnow’s Fall Workshop in the session “Navigating the Whirlwind Surrounding N-Nitrosamine Impurities in APIs and Drug Products” on October 1.

The workshop will focus on regulatory, scientific, and technical challenges surrounding the presence of N-nitrosamine impurities in active pharmaceutical ingredients (APIs) and drug products. Participants will explore cutting-edge methods, regulatory updates, and research developments regarding N-nitrosamines.

The workshop will address:

• U.S. Food and Drug Administration (FDA) perspective on N-Nitrosamine Impurities,
• International Generic and Biosimilar Medicines Association (IGBA) perspective on nitrosamine impurities, the worldwide challenges,
• ICH M7 risk assessment and control of N-nitrosamine impurities,
• Over-the counter (OTC) drug products and their challenges with N-nitrosamine impurities, and
• Prescription drug products and their challenges with N-Nitrosamine impurities.