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Critical Path Institute Secures Regulatory Support For Skeletal Muscle Safety Biomarkers
April 13, 2015 Critical Path Institute Secures Regulatory Support For Skeletal Muscle Safety Biomarkers FDA and EMA Letters of Support Suggest Valuable Research Potential TUCSON, Ariz., April 8, 2015 – The Critical Path Institute (C-Path) announced today that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued Biomarker […]
Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers
January 12, 2015 Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers EMA Letter of Support Opens Door for Clinical Qualification TUCSON, Ariz., January 12, 2015 – The Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) issued a first-of-its kind Biomarker Letter of Support for two essential kidney safety […]
C-Path and IMI 2nd Annual Meeting
Accelerating the Development of Drugs, Diagnostics, and Devices: Partnerships to Expand the Precompetitive Space Wednesday, December 3, 2014 Bethesda, MD, USA On December 3, 2014, the Critical Path Institute (C-Path) and Innovative Medicines Initiative (IMI) convened an international group of thought leaders to identify new ways to collaborate and achieve a common goal of a […]
Conference Highlights Public Private Partnership Role in Medical Product Development
December 3, 2014 | Download PDF Conference Highlights Public Private Partnership Role in Medical Product Development Global organizations convene cross-sector thought leaders to discuss public-private partnerships BETHESDA, MD, December 3, 2014—Today, the Critical Path Institute (C-Path) and Innovative Medicines Initiative (IMI) are convening an international group of thought leaders to identify new ways to […]
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C-Path Successes
- >>First preclinical safety biomarkers (7) qualified by the FDA, EMA and PMDA
- >>First imaging biomarker for trial enrichment qualified by the EMA
- >>FDA and EMA reach landmark decisions on C-Path’s Simulation Tool for Alzheimer’s disease
- >>C-Path’s Alzheimer’s Disease Simulator Featured in the Wall Street Journal
- >>C-Path and CDISC partnership delivers therapeutic area standards
- >>FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
- >>EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- >>Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- >>C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- >>C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD