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  6. DDT COA #000006: Asthma Daily Symptom Diary (ADSD)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000006: Asthma Daily Symptom Diary (ADSD)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Pulmonary, Allergy, and Critical Care (DPACC)

DDT COA Number
DDT COA #000006

Instrument Name
Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)


Concept of Interest
Severity of core defining asthma symptoms

Context of Use
Adolescent (12 -17 years) and adult patients

COA Type

Qualification Stage
In transition to 507 process 

Critical Path Institute: Patient-Reported Outcome (PRO) Consortium

Sonya Eremenco

Date Accepted into CDER’s COA Qualification Program
November 17, 2010

Qualification Date
March 28, 2019
Qualification Statement

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Full Qualification Package 5/31/18 FDA Response (Accepted) 3/28/19
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