The US Food and Drug Administration (FDA) is requesting stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and active pharmaceutical ingredients (APIs) to help inform safety assessments.
These novel nitrosamines, also called nitrosamine drug substance-related impurities (NDSRIs), were not addressed in FDA’s original nitrosamine guidance published in September 2020 nor the updated guidance issued in February 2021. (RELATED: N-Nitrosamine impurities: FDA issues detection, prevention guidance, Regulatory Focus 1 September 2020)
FDA said in a Federal Register notice this week that “NDSRIs present unique scientific and regulatory challenges for FDA because each NDSRI is unique to the API, and there is limited compound-specific data that is available to inform safety assessments. Additionally, design of validated test methods for identification of NDSRIs and modification of existing test methods for assessment of their mutagenic potential may raise novel scientific considerations.”…
