FDA acceptance of less-than-lifetime (LTL) adjustment for nitrosamine impurities: what you need to know
by David Ponting, Senior Principal Scientist, Lhasa Limited On 24 September 2026, the US Food and Drug Administration (FDA) published a guidance update, “Application of Less-Than-Lifetime Adjustment to Nitrosamine Impurities”, on the Center for Drug Evaluation and Research (CDER) nitrosamine guidance web page. For the first time, the FDA accepts that less-than-lifetime (LTL) adjustment factors,









