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In this section: Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000115: EPICOG-SCH

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Psychiatry (DP)

DDT COA Number
DDT COA #000115

Instrument Name
EPICOG-SCH

Disease/Condition
Schizophrenia

Concept of Interest
Cognitive impairment

Context of Use
Patients with schizophrenia

COA Type
PerfO

Qualification Stage
Letter of Intent- Accepted

Requestor(s)
Silvia Zaragoza Domingo

Contact(s)
Silvia Zaragoza Domingo

Date Accepted into CDER’s COA Qualification Program
June 30, 2019

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	4/10/19	FDA Response (Accepted)	6/30/19

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