FDA and EMA Letters of Support for the IMI SAFE-T program

At the EUROTOX 2009 conference in Dresden, the SAFE-T Project has been launched by Prof. Hüseyin FIRAT (President of Firalis) and it has recently achieved a major step.

The Innovative Medicines Initiative (IMI) SAFE-T (Safer and Faster Evidence Based Translation) Consortium and The Critical Path Institute (C-Path) have announced on 17th October 2016 that both, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have 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).

 The Letters of Support indicate that the new biomarkers have potential for use in humans, warranting additional exploration and data generation, and intend to encourage scientists to collect additional data from nonclinical and exploratory clinical studies. With this milestone, in-depth research can continue on the qualification of the new markers for use in clinical trials on top of standard safety tests.

 Read the SAFE-T PSTC Press release DILI FDA and EMA (click here)

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