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  6. DDT COA #000099: Child Asthma Diary (CAD)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000099: Child Asthma Diary (CAD)

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 #000099

Instrument Name
Child Asthma Diary (CAD)


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

Qualification Stage
Letter of Intent-Accepted

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

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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