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  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000104: Duchenne Video Assessment

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) I
Division of Neurology Products (DNP)

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

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