DDT COA #000112: Chronic Heart Failure- Symptom Scale (CHF-SS)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Cardiovascular and Nephrology (DCN)
DDT COA Number
DDT COA #000112
Instrument Name
Chronic Heart Failure- Symptom Scale (CHF-SS)
Disease/Condition
Chronic Heart Failure
Concept of Interest
CHF Symptoms
Context of Use
Patients with CHF
COA Type
PRO
Qualification Stage
Letter of Intent- Accepted
Requestor(s)
Critical Path Institute: Patient- Reported Outcome (PRO) Consortium, Chronic Heart Failure Working Group
Contact(s)
Sonya Eremenco
Date Accepted into CDER’s COA Qualification Program
April 30, 2019
Submission and Regulatory Correspondence History
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
---|---|---|---|
1/14/19 |
4/30/19 |