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  5. DDT COA #000108: Symptoms of Major Depressive Disorder Diary (SMDDD)
  1. Development & Approval Process | Drugs

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)

Major Depressive Disorder (MDD)

Concept of Interest
Depression symptom severity

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

COA Type

Qualification Stage
Letter of Intent- Accepted 

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

Stephen Coons

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

Submission History

Qualification Submission

Date Deemed Reviewable

FDA Submission Decision & Recommendations


Letter of Intent


FDA Response (Accepted)


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