News & Events
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April 27, 2015
Critical Path Institute Secures Regulatory Support For Parkinson’s And Alzheimer’s Disease Biomarkers
April 27, 2015 Critical Path Institute Secures Regulatory Support For Parkinson’s And Alzheimer’s Disease Biomarkers FDA Endorses Biomarkers for Use in Early Stages of Brain Disease TUCSON, Ariz., April 27, 2015 — Critical Path Institute (C-Path) announced that the U.S. Food and Drug Administration (FDA) has issued three Letters of Support to C-Path’s Coalition Against...... -
April 13, 2015
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...... -
February 6, 2015
European Medicines Agency Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
February 6, 2015 European Medicines Agency Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development Provides major boost for improved development of TB treatment to meet major public health challenge TUCSON, Ariz., February 6, 2015 – The Critical Path Institute (C-Path), an independent, nonprofit organization working to accelerate the process of drug and medical product development, announced...... -
January 15, 2015
CFAST Launches Two New CDISC Therapeutic Area Standards For Influenza and QT Studies
January 15, 2015 CFAST Launches Two New CDISC Therapeutic Area StandardsFor Influenza and QT Studies Austin, TX – 15 January 2015 – The Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute (C-Path) and TransCelerate BioPharma Inc. (“TransCelerate”) announced today that version 1.0 of the CDISC Influenza Therapeutic Area User Guide (TAUG) and version 1.0...... -
January 12, 2015
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......