January 7, 2014 Coalition Against Major Diseases/European Medicines Agency Biomarker Qualification Of Hippocampal Volume For Enrichment Of Clinical Trials In Predementia Stages Of Alzheimer’s Disease
June 23, 2014 Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, on FDA’s Critical Path Initiative
January 12, 2013 Patient-Reported Outcomes In Clinical Trials Of CKD-Related Therapies: Report Of A Symposium Sponsored By The National Kidney Foundation And The US Food And Drug Administration
October 29, 2013 Evolving Global Regulatory Science Through the Voluntary Submission of Data: A 2013 Assessment
July 10, 2013 U.S. Food and Drug Administration and European Medicines Agency Reach Landmark Decisions on Critical Path Institute’s Clinical Trial Simulation Tool for Alzheimer’s Disease
March 2, 2013 Opportunities and Challenges of Safety Biomarker Qualification: Perspectives from the Predictive Safety Testing Consortium
October 25, 2012 FDA Works with Partners to Establish Important Therapeutic Area Data Standards Clarification, November 5, 2012: CFAST is a joint initiative of CDISC and the Critical Path Institute. The FDA and TransCelerate B
