November 8, 2011 Brian Harvey, VP, U.S. Regulatory Policy at Sanofi, speaks on panel at Partnering for Cures Nov. 8, 2011 Highlights benefits of public-private partnerships like C-Path’s Coalition Against Major Diseases (CAMD): Stresses importanc
October 29, 2011 C-Path’s Avilés Discusses Importance of Data Standards in FDA Week Article FDA is encouraging industry to use newly crafted therapeutic data standards — such as utilization of qualified biomarkers
July 5, 2011 The PRO Consortium: An FDA-Endorsed Process for PRO Instrument Development in GI Disorders and Beyond
April 30, 2011 Critical Path Institute Announces Expansion of Regulatory Science Consortium For Tuberculosis Critical Path Institute is proud to announce that the Regulatory Science Consortium, an arm of the Critical Path to TB Drug Regime
June 11, 2010 Critical Path Institute’s Predictive Safety Testing Consortium Announces First-Ever Qualification Decision by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). For the first time, new biomarker tests to detect drug-induced kidney injury have been accepted by the Japanese Pharmaceuticals an
May 11, 2010 Kidney injury Molecule-1 Outperforms Traditional Biomarkers of Kidney Injury in Preclinical Biomarker Qualification Studies
October 5, 2010 Renal Biomarker Qualification Submission: A Dialog Between the FDA-EMEA and Predictive Safety Testing Consortium
