DDT COA #000104: Duchenne Video Assessment

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology (DN I)

DDT COA Number
DDT COA #000104

Instrument Name
Duchenne Video Assessment

Disease/Condition
Duchenne Muscular Dystrophy (DMD)

Concept of Interest
Quality of movement

Context of Use
Ambulatory patients > 4 years old with DMD

COA Type
ClinRO

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
Casimir

Contact(s)
Mindy Leffler

Date Accepted into CDER’s COA Qualification Program
January 23, 2019

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	10/25/18	FDA Response (Accepted)	1/23/19