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  5. DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) specific to CABP and HABP
  1. Development & Approval Process (Drugs)

DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) specific to CABP and HABP

DDT COA #000018: 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 #000018

Instrument Name
Community-Acquired Bacterial Pneumonia Daily Symptom Diary

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
In transition to 507 process 

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

Contact(s)
Steve Hoffman 

Date Accepted into CDER’s COA Qualification Program
May 7, 2013

Submission History

Qualification Submission Date Required FDA Submission Decision & Recommendations Date
Update 2/3/17 FDA Response 8/17/17
Update 10/19/17 FDA Response 3/22/18
Qualification Submission Date Required FDA Submission Decision & Recommendations Date
Update 6/14/18 FDA Response 6/26/18
Update 9/26/18 FDA Response 1/18/19

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