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 |