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DDT COA #000069: Fatigue PRO in Multiple Sclerosis

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

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)
Stephen Coons

Date Accepted into CDER’s COA Qualification Program
June 21, 2017

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

--

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Transition Letter to 507 Process

9/5/19

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