FDA Nitrosamine Impurities - 医薬品におけるﾆﾄﾛｿｱﾐﾝ類混入ﾘｽｸ

Update [09/04/2024] FDA issued a new revised guidance for immediate implementation, “Control of Nitrosamine Impurities in Human Drugs,” that explains the agency’s updated thinking about how drug manufacturers and applicants can detect and prevent unacceptable levels of nitrosamine impurities in their products, including nitrosamine drug substance related impurities (NDSRIs). The revised guidance also provides a timeline for manufacturers to implement these recommendations.

Update [08/04/2023] FDA issued a new guidance for immediate implementation, “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs),” which provides drug manufacturers and applicants with a recommended framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA. 

https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications#nitrosamine-impurities