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…
Past Events
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Apr 19, 2023 - Apr 20, 2023 Register Now: 14th Annual Patient-Reported Outcome Consortium Workshop
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Feb 28, 2023 Test Upcomming Event 2
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Feb 25, 2023 Test Upcomming Event
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Feb 6, 2023 Test Past Event
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Feb 1, 2023 Test Past Event 2
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