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DDT COA #000071: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of HABP symptoms

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
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
June 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

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