U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool Qualification Programs
  5. DDT COA #000019: Skin Infection Patient-Reported Outcome Measure (SKINFECT-PRO)
  1. Drug Development Tool Qualification Programs

DDT COA #000019: Skin Infection Patient-Reported Outcome Measure (SKINFECT-PRO)

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

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

Back to Clinical Outcome Assessments (COA) Qualification Submission