Critical Path Institute, founded in 2005 in Tucson, Arizona, is an independent, nonprofit organization dedicated to bringing together experts from regulatory agencies, industry, and academia to collaborate and improve the medical product development process. More…
Upcoming Events
Past Events
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Jan 21, 2021 - Jan 21, 2021 Watch now: RDCA-DAP and EATRIS Present Rare Disease Drug Develoment Webinar
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Oct 29, 2020 COVID-19: Risk Assessment and Mitigation Strategies for the Collection of PRO Data through Clinical Sites – Lessons Learned
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Oct 28, 2020 - Oct 29, 2020 October 28-29 | International Neonatal Consortium 2020 Virtual Workshop
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Oct 27, 2020 Critical Path for Alzheimer’s Disease 2020 Annual Meeting and Regulatory Science Workshop – Virtual
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Oct 19, 2020 - Oct 19, 2020 Workshop: RDCA-DAP 2020 Virtual Workshop
Successes
- COA Qualification from FDA for Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
- Qualification of drug-induced kidney injury (DIKI) clinical safety biomarker, composite measure
- COA Qualification from FDA for the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
- C-Path receives COA qualification from FDA for the Symptoms of Major Depressive Disorder Scale (SMDDS)
- C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD
- C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- C-Path Opportunities Table
- EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
News
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Jan 14, 2021 C-Path Announces SHIP-MD 2021 Virtual Workshop
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Jan 7, 2021 Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim
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Dec 16, 2020 C-Path and Diamyd Medical Announce Data Sharing Collaboration to Develop Advanced Drug Development Tools in Type 1 Diabetes
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Dec 3, 2020 C-Path Selects Aridhia to Support Rare Disease Cures Accelerator-Data and Analytics Platform
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Dec 3, 2020 C-Path, Ltd. Announces New Contract with Innovative Medicines Initiative
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Dec 2, 2020 C-Path Quantitative Medicine Program Awarded FDA Contract to Develop Tools for Neuroscience Diseases