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
Critical Path Institute Gathers Cross-Sector Innovators at Global Conference on Drug Development Hundreds of leaders from cross-sector arenas in government, academia, the biotechnology and pharmaceutical industry, and patient a
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
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
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
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
