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  4. DDT COA #000024: Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module (PEESS™ v2.0)
  1. Development & Approval Process | Drugs

DDT COA #000024: Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module (PEESS™ v2.0)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) III
Division of Gastroenterology and Inborn Error Products (DGIEP)

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

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Transition Letter to 507 Process

9/5/19

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