U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000106: Actibelt® in Multiple Sclerosis
  1. Clinical Outcome Assessment (COA) Qualification Program

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

 

Back to Top