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In this section: Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000138: Opioid Craving PRO

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP)

DDT COA Number
DDT COA #000138

Instrument Name
Opioid Craving

Disease/Condition
Opioid Use Disorder (OUD)

Concept of Interest
Changes in opioid craving

Context of Use
Patients with mild to severe OUD

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Johns Hopkins University School of Medicine

Contact(s)
Cecilia Bergeria
Kelly Dunn
Eric Strain

Date Accepted into CDER’s COA Qualification Program
October 2, 2020

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	7/15/20	FDA Response (Accepted)	10/2/20

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