On 24 September 2026, CDER announced that the LTL approach described in ICH M7(R2) may now be applied to acceptable intake (AI) limits for nitrosamine impurities. Until now, CDER had not accepted this approach.
What this means in practice:
- Drug products with shorter treatment durations, as defined in the approved labeling, may justify higher AI limits (up to 80× for treatments of 1 month or less)
- Applicants with applications pending with FDA should inform CDER if they intend to propose an LTL-adjusted AI limit and amend their application as appropriate.
This is a meaningful opportunity for short-term and intermittent therapies, provided it is supported by a solid scientific justification.
At TEAM mastery, we support companies in nitrosamine risk assessment and AI limit derivation. Get in touch to find out whether your products could benefit.