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  5. DDT COA #000093: PROMIS® Pediatric Crohn’s Disease Short Form- Pain Interference
  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000093: PROMIS® Pediatric Crohn’s Disease Short Form- Pain Interference

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)

DDT COA Number
DDT COA #000093

Instrument Name
PROMIS® Pediatric Crohn’s Disease Short Form- Pain Interference

Disease/Condition
Crohn’s Disease (CD)

Concept of Interest
Pain Interference

Context of Use
Children (8-17 years) with CD

COA Type
PRO

Qualification Stage
Letter of Intent- Not Accepted

Requestor(s)
Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium

Contact(s)
Carole Tucker
Christopher Forrest

Date Accepted into CDER’s COA Qualification Program
N/A

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 8/5/19 FDA Response (Not Accepted) 9/26/19
 
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