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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
Letter of Intent-Accepted

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 and Regulatory Correspondence History

Qualification Submission Date 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
- - Transition Letter to 507 Process 9/5/19

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