DDT COA #000019: Skin Infection Patient-Reported Outcome Measure (SKINFECT-PRO)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Infectious Diseases (OID)
Division of Anti-Infectives (DAI)
DDT COA Number
DDT COA #000019
Instrument Name
Skin Infection Patient-Reported Outcome Measure (SKINFECT-PRO)
Disease/Condition
Acute Bacterial Skin and Skin Structure Infection
Concept of Interest
ABSSSI symptoms
Context of Use
Adult patients (> 18 years) with ABSSSI
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
March 1, 2013
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Update | 2/3/17 | FDA Response | 11/20/17 |
| Update | 6/14/18 | FDA Response | 9/26/18 |
| - | - | Transition Letter to 507 Process | 9/5/19 |