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  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000151: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000151: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)

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

DDT COA Number
DDT COA #000151

Instrument Name
Diary for Irritable Bowel Syndrome Symptoms- Mixed (DIBSS-M)

Disease/Condition
Irritable Bowel Syndrome (IBS)

Concept of Interest
Symptom severity

Context of Use
Adults who meet Rome diagnostic criteria (Rome III or IV) for IBS-M and have active symptoms

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted

Requestor(s)
Critical Path Institute: Patient Reported Outcome (PRO) Consortium

Contact(s)
Sonya Eremenco

Date Accepted into CDER’s COA Qualification Program
May 14, 2015

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Transition Summary

5/24/21

FDA Response

5/24/21
 
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