DDT COA #000032: Abilities Captured through Interactive Video Evaluation (ACTIVE)-seated
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology I (DN I)
DDT COA Number
DDT COA #000032
Instrument Name
Abilities Captured through Interactive Video Evaluation (ACTIVE)-seated
Disease/Condition
Dystrophinopathy
Concept of Interest
Functional reaching volume (FRV) intended to encompass upper extremity and trunk movement
Context of Use
Children (>4-12 years) and adolescents (12-17 years) and adults with Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD)
COA Type
PerfO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
The Research Institute at Nationwide Children’s Hospital
Contact(s)
Linda Lowes
Date Accepted into CDER’s COA Qualification Program
May 30, 2013
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
9/5/19 |