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  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000041: TUMMY- UC

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

DDT COA Number
DDT COA #000041

Instrument Name
TUMMY- UC

Disease/Condition
Ulcerative colitis (UC)

Concept of Interest
UC signs and symptoms severity

Context of Use
Children and adolescents (2-18 years) with UC

COA Type
PRO/ObsRO

Qualification Stage
Withdrawn

Requestor(s)
Dan Turner
Anne Griffiths

Contact(s)
Dan Turner
Anne Griffiths

Date Accepted into CDER’s COA Qualification Program
February 7, 2013

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Update 8/3/18 FDA Response 1/25/19