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