ICH S1 Addendum to Carcinogenicity Provides Opportunity to Reduce Testing on Animals

The US Food and Drug Administration will now consider data submitted using the Addendum to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on carcinogenicity testing of pharmaceuticals. The Addendum provides guidance for using a weight-of-evidence approach that will shift resources to generating more mechanism-based carcinogenicity assessments and reduce lifetime testing on rats and mice.

Read the guidance document here.