DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of CABP symptoms
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Infectious Diseases (OID)
Division of Anti-Infectives (DAI)
DDT COA Number
DDT COA #000018
Instrument Name
Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of CABP symptoms
Disease/Condition
Community-Acquired Bacterial Pneumonia (CABP)
Concept of Interest
CABP symptoms
Context of Use
Adult patients (> 18 years) with CABP
COA Type
PRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Foundation for the National Institutes of Health (FNIH)
Contact(s)
Steve Hoffman
Kellee Howard
Date Accepted into CDER’s COA Qualification Program
May 7, 2013
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Update | 2/3/17 | FDA Response | 8/17/17 |
| Update | 10/19/17 | FDA Response | 3/22/18 |
| Update | 6/14/18 | FDA Response | 6/26/18 |
| Update | 9/26/18 | FDA Response | 1/18/19 |
| - | - | Transition Letter to 507 Process | 9/5/19 |