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

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

DDT COA Number
DDT COA #000006

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

Disease/Condition
Asthma

Concept of Interest
Severity of core defining asthma symptoms

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

COA Type
PRO

Qualification Stage
In transition to 507 process 

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

Contact(s)
Stephen Coons

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

Qualification Date
March 28, 2019

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

Qualification Statement (PDF)

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