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  6. DDT COA #000020: The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000020: The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)

DDT COA Number
DDT COA #000020

Instrument Name
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD)

Disease/Condition
Gastroparesis

Concept of Interest
Gastroparesis symptoms

Context of Use
Adult patients (>18 years) with idiopathic or diabetic gastroparesis

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
American Neurogastroenterology and Motility Society
Contact(s)
Henry Parkman

Date Accepted into CDER’s COA Qualification Program
December 27, 2011

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Update 3/8/18 FDA Response 8/2/18
Update
Appendix A
Appendix B
Appendix C
Appendix D1
Appendix D2
Appendix E		 10/28/18 FDA Response 1/16/19
- - Transition Letter to 507 Process 9/5/19
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