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17 October 2016 - IMI SAFE-T and C-Path PSTC Obtain Regulatory Support For New Liver Safety Biomarkers

FDA and EMA Letters of Support Pave the Way for Clinical Qualification   The Innovative Medicines Initiative (IMI) SAFE-T (Safer and Faster Evidence Based Translation) Consortium and The Critical Path Institute (C-Path) announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) each issued a Biomarker Letter of Support for new liver safety biomarkers investigated by the SAFE-T Drug-Induced Liver Injury Work Package, and the Predictive Safety Testing Consortium’s (PSTC) Hepatotoxicity Working Group. Research work was supported by the Drug-Induced Liver Injury Network (DILIN) in the US, an expert network established by The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).


You find the press release here