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

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 Drug Evaluation (ODE) III
Division of Gastroenterology and Inborn Error Products (DGIEP)

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
In transition to 507 process 

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

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

Submission History

Qualification Submission Date Required 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

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