DDT COA #000034: Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)
DDT COA Number
DDT COA #000034
Instrument Name
Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)
Disease/Condition
Crohn’s disease (CD)
Concept of Interest
Signs and symptoms of CD
Context of Use
Adult patients (>18 years) with moderate to severe clinically active CD treated in the outpatient setting
COA Type
PRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
IBD PRO Consortium
Contact(s)
Gale Harding
Date Accepted into CDER’s COA Qualification Program
April 1, 2013
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/5/19 |