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  5. DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of CABP symptoms
  1. Drug Development Tool Qualification Programs

DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of CABP symptoms

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

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

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