DDT COA #000013: Functional Dyspepsia Symptom Diary (FDSD)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)
DDT COA Number
DDT COA #000013
Instrument Name
Functional Dyspepsia Symptom Diary (FDSD)
Disease/Condition
Functional dyspepsia (FD)
Concept of Interest
FD symptom severity
Context of Use
Adult patients that have met Rome III diagnostic criteria for FD
COA Type
PRO
Qualification Stage
Letter of Intent - Accepted
Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium
Functional Working Group
Contact(s)
Sonya Eremenco
Date Accepted into CDER’s COA Qualification Program
February 29, 2012
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|
11/14/17 |
1/23/19 |
||
|
- |
- |
9/5/19 |