DDT COA #000069: Fatigue PRO in Multiple Sclerosis
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology II (DN II)
DDT COA Number
DDT COA #000069
Instrument Name
Fatigue PRO in Multiple Sclerosis
Disease/Condition
Multiple Sclerosis (MS)
Concept of Interest
Fatigue
Context of Use
Patients with MS
COA Type
PRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium
Multiple Sclerosis Working Group
Contact(s)
Sonya Eremenco
Date Accepted into CDER’s COA Qualification Program
June 21, 2017
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/5/19 |