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  6. DDT COA #000103: ActiMyo®
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000103: ActiMyo®

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


DDT COA Number
DDT COA #000103

Instrument Name

Duchenne Muscular Dystrophy (DMD)

Concept of Interest
Daily motor activity

Context of Use
Children, adolescent, and adult patients (> 5 years old) with DMD

COA Type
DHT- Passive Monitoring COA

Qualification Stage
Letter of Intent - Accepted

Marc Grelet

Date Accepted into CDER’s COA Qualification Program
August 30, 2018

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 9/21/17 FDA Response (Accepted) 8/30/18


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