U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. DDT COA #000090: Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM)
  1. Drugs

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

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

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

Back to Clinical Outcome Assessments (COA) Qualification Submission