Industry stakeholders urged the US Food and Drug Administration (FDA) to postpone its October 2023 deadline for testing drug products for novel nitrosamines, saying there is still much scientific uncertainty on how to test these products and how to set daily acceptable limits in light of scarce toxicological data for these impurities. Until these issues are resolved, FDA should hold off establishing a deadline, industry groups said.
These comments were in response to the agency’s request for public input on how it should regulate novel nitrosamines, also called nitrosamine drug substance-related impurities (NDSRIs), to help inform safety assessments. The agency’s notice acknowledged the challenge of setting impurity levels for NDSRIs. (RELATED: FDA wants feedback on testing methods for new nitrosamines, Regulatory Focus 5 May 2023)…
