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DDT COA #000099: Child Asthma Diary (CAD)

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 #000099

Instrument Name
Child Asthma Diary (CAD)

Disease/Condition
Asthma

Concept of Interest
Symptom severity

Context of Use
Children (4-11 years) with a clinical diagnosis of mild to severe persistent asthma requiring a daily long-term control medication

COA Type
PRO/ObsRO

Qualification Stage
In transition to 507 process 

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

Contact(s)
Stephen Coons

Date Accepted into CDER’s COA Qualification Program
June 13, 2017

Submission History

Qualification Submission Date Received FDA Submission Decision & Recommendations Date
Letter of Intent 12/2/16 FDA Response (Accepted) 6/9/17
Update 8/25/17 FDA Response 5/23/18

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