Liver

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

    Micrograph of an intrahepatic cholangiocarcinoma (right of image) adjacent to benign hepatocytes (left of image). H&E stain.

    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.