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  1. Drug Development Tool Qualification Programs

DDT COA #000107: Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

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

DDT COA Number
DDT COA #000107

Instrument Name
Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

Disease/Condition
Schizophrenia

Concept of Interest
Functional capacity

Context of Use
Patients with schizophrenia

COA Type
PerfO

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
NeuroCog Trials, Inc

Contact(s)
Richard Keefe

Date Accepted into CDER’s COA Qualification Program
February 5, 2019

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Letter of Intent

10/12/18

FDA Response (Accepted)

2/5/19

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