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  1. Drug Development Tool Qualification Programs

DDT COA #000115: EPICOG-SCH

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

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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