DDT COA #000024: Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module (PEESS™ v2.0)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)
DDT COA Number
DDT COA #000024
Instrument Name
Pediatric Eosinophilic Esophagitis (EoE) Score (PEES™ v2.0)
Disease/Condition
Eosinophilic Esophagitis (EoE)
Concept of Interest
EoE Symptoms
Context of Use
Children (2-12 years) and adolescents (12-18 years) with EoE
COA Type
ObsRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Marc Rothenberg
Contact(s)
Marc Rothenberg
Date Accepted into CDER’s COA Qualification Program
January 3, 2012
Submission and Regulatory Correspondence History
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
---|---|---|---|
-- |
-- |
9/5/19 |