News & Events

PD Imaging Biomarker Team at European Medicines Agency (EMA)

Experts of the Parkinson’s disease imaging biomarker team participated in a Scientific Advice meeting at the European Medicines Agency on October 7th 2015. The purpose of this meeting was to review the evidence provided to the Agency that supports the use of Molecular Imaging of the Dopamine Transporter as an enrichment biomarker in clinical trials […]

Critical Path Institute Secures Regulatory Support For Skeletal Muscle Safety Biomarkers

April 13, 2015 Critical Path Institute Secures Regulatory Support For Skeletal Muscle Safety Biomarkers FDA and EMA Letters of Support Suggest Valuable Research Potential TUCSON, Ariz., April 8, 2015 – The Critical Path Institute (C-Path) announced today that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued Biomarker […]

Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers

January 12, 2015 Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers EMA Letter of Support Opens Door for Clinical Qualification TUCSON, Ariz., January 12, 2015 – The Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) issued a first-of-its kind Biomarker Letter of Support for two essential kidney safety […]