April 4, 2012 Third Annual Patient-Reported Outcome Consortium Workshop April 4, 2012 Sheraton Silver Spring Hotel 8777 Georgia Avenue – Silver Spring, MD 20910 SPONSORED BY: Critical Path Institu
European Medicines Agency Deems Imaging Biomarker a Qualified Measure to Select Patients with Early Stages of Cognitive Impairment for Alzheimer’s Disease Clinical Trials Based on a request for regulatory review by Critical Path Institute’s (C-Path) Coalition Against Major Diseases (CAMD), the
March 23, 2010 First Annual Patient-Reported Outcome Consortium Workshop March 23, 2010 Sheraton Silver Spring Hotel 8777 Georgia Avenue – Silver Spring, MD 20910 SPONSORED BY: Critical Path Instit
October 5, 2010 Renal Biomarker Qualification Submission: A Dialog Between the FDA-EMEA and Predictive Safety Testing Consortium
FDA & EMEA to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration
C-Path Leads Novel Transatlantic Drug Safety Effort Companies receive go ahead from FDA and EMEA to use new improved tests when assessing safety of new drugs.
