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  1. Drug Development Tool Qualification Programs

DDT COA #000123: Physical Function 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 #000123

Instrument Name
Physical Function PRO in Multiple Sclerosis

Disease/Condition
Multiple Sclerosis (MS)

Concept of Interest
Physical Functioning

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

9/11/19

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