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DDT COA #000071: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) specific to CABP and HABP

DDT COA #000071: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) specific to CABP and HABP

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Antimicrobial Products (OAP)
Division of Anti-Infective Products (DAIP)

DDT COA Number
DDT COA #000071

Instrument Name
Hospital- Acquired Bacterial Pneumonia Daily Symptom Diary

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
In transition to 507 process 

Requestor(s)
Foundation for the National Institutes of Health (FNIH)

Contact(s)
Steve Hoffman
Kellee Howard
Date Accepted into CDER’s COA Qualification Program
June 2015

Submission History

Qualification Submission Date Required FDA Submission Decision & Recommendations Date
Update 5/4/17 FDA Response 12/1/17

Back to Clinical Outcome Assessments (COA) Qualification Submission