News

All years
Bitte geben Sie einen Suchbegriff ein.

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

zurück