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  5. DDT COA #000142: Virtual Motor Exam for Parkinson’s Disease, Part III Estimator (VME Part III)
  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000142: Virtual Motor Exam for Parkinson’s Disease, Part III Estimator (VME Part III)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology I (DN1)

DDT COA Number
DDT COA #000142

Instrument Name
Virtual Motor Exam for Parkinson’s Disease, Part III Estimator (VME Part III)

Disease/Condition
Parkinson’s Disease

Concept of Interest
Motor symptom severity

Context of Use
Adults diagnosed with Parkinson’s Disease

COA Type
DHT – Passive monitoring COA

Qualification Stage
Letter of Intent-Not Accepted

Requestor(s)
Verily Life Sciences

Contact(s)
Dinesh Puppala

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

03/16/2021

FDA Response (Not Accepted)

5/13/21
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