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  4. DDT COA #000092: PROMIS® Pediatric Crohn’s Disease Short Form - Fatigue 10
  1. Development & Approval Process | Drugs

DDT COA #000092: PROMIS® Pediatric Crohn’s Disease Short Form - Fatigue 10

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 #000092

Instrument Name
PROMIS® Pediatric Crohn’s Disease Short Form - Fatigue 10

Disease/Condition
Crohn’s disease (CD)

Concept of Interest
Fatigue (frequency, duration and intensity)

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

COA Type
PRO

Qualification Stage
Letter of Intent - Accepted

Requestor(s)
Anthony Otley

Contact(s)
Carole Tucker
Christopher Forrest

Date Accepted into CDER’s COA Qualification Program
July 11, 2017

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 1/31/17 FDA Response (Accepted) 7/11/2017

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