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  1. Development & Approval Process (Drugs)

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

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 History

Qualification Submission

Date Deemed Reviewable

FDA Submission Decision & Recommendations

Date

Letter of Intent

11/5/18

FDA Response (Accepted)

2/4/19

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