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DDT COA #000034: Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)

Office of Drug Evaluation (ODE) III
Division of Gastroenterology and Inborn Error Products (DGIEP)

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

--

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Transition Letter to 507 Process

9/5/19

Back to Clinical Outcome Assessments (COA) Qualification Submission