DDT COA #000106: Actibelt® in Multiple Sclerosis
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology II (DN II)
DDT COA Number
DDT COA #000106
Instrument Name
Actibelt® in Multiple Sclerosis
Disease/Condition
Multiple Sclerosis
Concept of Interest
change in real-world walking speed
Context of Use
Patients with multiple sclerosis
COA Type
DHT- Passive Monitoring COA
Qualification Stage
Letter of Intent- Accepted
Requestor(s)
Martin Daumer
Contact(s)
Martin Daumer
Date Accepted into CDER’s COA Qualification Program
January 18, 2019
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
|
9/20/18 |
1/18/19 |