DDT COA #000076: TUMMY-CD
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
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/5/19 |