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)

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

Qualification Stage
Letter of Intent – Accepted 

Critical Path Institute: Patient-Reported Outcome (PRO) Consortium
Functional Working Group

Stephen Coons

Date Accepted into CDER’s COA Qualification Program
February 29, 2012

Submission and Regulatory Correspondence History