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)
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 |