DDT COA #000049: Pediatric Inflammatory Crohn’s MRE Index (PICMI)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)
DDT COA Number
DDT COA #000049
Instrument Name
Pediatric Inflammatory Crohn’s MRE Index (PICMI)
Disease/Condition
Crohn’s Disease
Concept of Interest
Disease Activity
Context of Use
Children (5-17 years) with CD
COA Type
ClinRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Dan Turner
Anne Griffiths
Contact(s)
Dan Turner
Anne Griffiths
Date Accepted into CDER’s COA Qualification Program
November 16, 2012
Submission and Regulatory Correspondence History
| Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/9/19 |