DDT COA #000071: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of HABP symptoms
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Infectious Diseases (OID)
Division of Anti-Infectives (DAI)
DDT COA Number
DDT COA #000071
Instrument Name
Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of HABP symptoms
Disease/Condition
Hospital-acquired Bacterial Pneumonia (HABP)
Concept of Interest
HABP symptoms
Context of Use
Adult patients (> 18 years) with HABP
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
September 14, 2015
Submission and Regulatory Correspondence History
| Qualification Submission | Date Received | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Update | 5/4/17 | FDA Response | 12/1/17 |
| - | - | Transition Letter to 507 Process | 9/5/19 |