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DDT COA #000041: TUMMY- UC

DDT COA #000041: TUMMY- UC

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 #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Withdrawn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 History

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

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