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Posted 19 April 2012 | By Ansis HelmanisRegLink
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.
Health Canada - Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products
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