DDT COA #000040: Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)
DDT COA Number
DDT COA #000040
Instrument Name
Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS)
Disease/Condition
Ulcerative colitis (UC)
Concept of Interest
Signs and symptoms of UC
Context of Use
Adult patients (≥18 years of age) with moderate to severe UC
COA Type
PRO
Qualification Stage
In legacy process*
Requestor(s)
IBD PRO Consortium
Contact(s)
Gale Harding
Date Accepted into CDER’s COA Qualification Program
March 14, 2013
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/5/19 |
*Under review prior to the passage of the 21st Century Cures Act