November 13, 2015 C-Path’s Polycystic Kidney Disease Outcomes Consortium Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD TUCSON, Ariz., November 13, 2015 – The Critical Path Institute (C-Path) announced today that the European Medicines Agency (EM
November 9, 2015 CDISC and C-Path Continue CFAST Partnership with Recently Awarded FDA Grants October 12, 2015 CDISC and C-Path Continue CFAST Partnership with Recently Awarded FDA Grants Austin, TX – 12 October 2015 – T
October 15, 2015 Coalition Against Major Diseases and FDA 2015 Annual Scientific Workshop October 15, 2015 FDA White Oak Campus CO-SPONSORED BY: Critical Path Institute U.S. Food and Drug Administration Overview and Obje
September 2, 2015 Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium On August 21st, the University of Maryland&
August 30, 2015 Critical Path Institute’s Polycystic Kidney Disease Outcomes Consortium Secures FDA Qualification for Enrichment Biomarker in Autosomal Dominant Polycystic Kidney Disease (ADPKD) TUCSON, Ariz., August 31, 2015 – The Critical Path Institute (C-Path) announced today that the U.S. Food and Drug Administration
July 8, 2015 Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates Offringa M, Davis JM, Turner MA, Ward R, Bax R, Maldonado S, Sinha V, McCune SK, Zajicek A, Daniel K. Benjamin J, Bucci-Rechtweg C
July 27, 2015 FDA: Guidance for Industry Duchenne Muscular Dystrophy Developing Drugs for Treatment Over the Spectrum of Disease
July 14, 2015 The Predictive Safety Testing Consortium: Safety Biomarkers, Collaboration, and Qualification
