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  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000090: Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000090: Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM)

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

DDT COA Number
DDT COA #000090

Instrument Name
Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM)

Disease/Condition
Facioscapulohumeral muscular dystrophy (FSHD)

Concept of Interest
Physical functioning

Context of Use
Patients with FSHD

COA Type
PerfO

Qualification Stage
Letter of Intent - Not Accepted

Requestor(s)
Jeffrey Statland

Contact(s)
Jeffrey Statland
Date Accepted into CDER’s COA Qualification Program
n/a

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 11/20/17 FDA Response (Not Accepted) 8/30/18
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