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DDT COA #000076: TUMMY-CD

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 #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

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

--

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Transition Letter to 507 Process

9/5/19

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