Canada: Health Canada Issues Final Guidance On Pre-market Evaluation of Hepatotoxicity

Health Canada issued final guidance to sponsors yesterday on the detection, assessment, mitigation and reporting of hepatoxicity for pharmaceuticals, radiopharmaceuticals and biologic drugs for human use. 

A draft version of the guidance was first released for consultation on 16 February 2011. 

There were 125 comments received and changes were incorporated where appropriate. 