Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)

DDT COA Number
DDT COA #000076

Instrument Name
TUMMY-CD

Disease/Condition
Crohn’s disease (CD)

Concept of Interest
Signs and symptoms of CD

Context of Use
Pediatric patients with CD

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Anthony Otley

Contact(s)
Anthony Otley

Date Accepted into CDER’s COA Qualification Program
July 9, 2015

Submission and Regulatory Correspondence History