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  5. DDT COA #000108: Symptoms of Major Depressive Disorder Diary (SMDDD)
  1. Drug Development Tool Qualification Programs

DDT COA #000108: Symptoms of Major Depressive Disorder Diary (SMDDD)

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

DDT COA Number
DDT COA #000108

Instrument Name
Symptoms of Major Depressive Disorder Diary (SMDDD)

Disease/Condition
Major Depressive Disorder (MDD)

Concept of Interest
Depression symptom severity

Context of Use
Adults with MDD with a 24-hour recall period

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
Critical Path Institute: Patient- Reported Outcome (PRO) Consortium, Depression Working Group

Contact(s)
Stephen Coons

Date Accepted into CDER’s COA Qualification Program
February 4, 2019

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Letter of Intent

11/5/18

FDA Response (Accepted)

2/4/19

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