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

IMI SAFE-T and C-Path PSTC Obtain Regulatory Support For New Liver Safety Biomarkers 1 Monat 2 Wochen her #1

  • Lisa Feder
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Research work was supported by the Drug-Induced Liver Injury Network...

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.

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