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  5. DDT COA #000049: Pediatric Inflammatory Crohn’s MRE Index (PICMI)
  1. Drug Development Tool Qualification Programs

DDT COA #000049: Pediatric Inflammatory Crohn’s MRE Index (PICMI)

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 #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

--

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Transition Letter to 507 Process

9/9/19

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