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  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000114: Chronic Heart Failure- Activity Monitor-Based Endpoint Measure
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000114: Chronic Heart Failure- Activity Monitor-Based Endpoint Measure

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 #000114

Instrument Name
Chronic Heart Failure- Activity Monitor-Based Endpoint Measure

Disease/Condition
Chronic Heart Failure

Concept of Interest
Daily physical activity

Context of Use
Patients with CHF

COA Type
DHT- Passive Monitoring COA

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
May 3, 2019

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Letter of Intent

1/14/19

FDA Response (Accepted)

5/3/19

 

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