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  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000013: Functional Dyspepsia Symptom Diary (FDSD)
  1. Clinical Outcome Assessment (COA) Qualification Program

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

Update

11/14/17

FDA Response

1/23/19

-

-

Transition Letter to 507 Process

9/5/19
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