Proposed change to rodent carcinogenicity testing of pharmaceuticals - regulatory notice for public input

A change to the current ICH S1 guidance on rodent carcinogenicity testing is being considered. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2-yr rodent carcinogenicity studies add value to that assessment. Read more here.