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  6. DDT COA #000040: Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS)
  1. Clinical Outcome Assessment (COA) Qualification Program

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

--

--

Transition Letter to 507 Process

9/5/19

*Under review prior to the passage of the 21st Century Cures Act

 
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