U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. DDT COA #000053: Symbol Digit Modalities Test (SDMT)
  1. Drugs

DDT COA #000053: Symbol Digit Modalities Test (SDMT)

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

DDT COA Number
DDT COA #000053

Instrument Name
Symbol Digit Modalities Test (SDMT)

Disease/Condition
Multiple Sclerosis (MS)

Concept of Interest
Processing speed

Context of Use
Adults with a diagnosis of MS and a relapsing-remitting (RRMS), secondary progressive (SPMS), or primary progressive (PPMS) clinical course

COA Type
PerfO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Critical Path Institute
Multiple Sclerosis Outcome Assessments Consortium (MSOAC)

Contact(s)
Lynn Hudson

Date Accepted into CDER’s COA Qualification Program
December 23, 2013

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

--

--

Transition Letter to 507 Process

8/27/19

Back to Clinical Outcome Assessments (COA) Qualification Submission