From Ambiguity to Action: The FDA’s New Nitrosamine Guidance

Nitrosamine contamination in pharmaceutical products has become a critical concern within the industry due to the potential carcinogenic risks these impurities pose. The U.S. Food and Drug Administration (FDA) has taken an active role in addressing these concerns, issuing warnings about the risks associated with Nitrosamine Drug Substance-Related Impurities (NDSRIs). New guidance from the FDA provides a clearer path forward for drug manufacturers, including strategies for lobbying alternative limits and demonstrating bioequivalence when using nitrite scavengers.

In this webinar, we’ll break down the FDA’s newly finalized guidance and discuss both established and emerging techniques to reduce nitrosamine formation in your products and stay compliant.

Key Objectives:

• Gain a comprehensive understanding of the latest regulatory updates
• Identify which products are most vulnerable to nitrosamine contamination
• Explore both proven and innovative strategies for mitigating nitrosamine risks