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  5. DDT COA #000106: Actibelt® in Multiple Sclerosis
  1. Drug Development Tool (DDT) Qualification Programs

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

Letter of Intent

Appendix

9/20/18

FDA Response (Accepted)

1/18/19

 

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