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  6. DDT COA #000073: QUALIfied for Therapeutic Evaluations of Pain (QUALITE-Pain)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000073: QUALIfied for Therapeutic Evaluations of Pain (QUALITE-Pain)

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

DDT COA Number
DDT COA #000073

Instrument Name
QUALIfied for Therapeutic Evaluations of Pain (QUALITE-Pain)
Disease/Condition
Pain

Concept of Interest
Pain intensity

Context of Use
Non-cognitively impaired adults with acute and chronic pain

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)

Contact(s)
Shannon Smith
Robert Dworkin
Dennis Turk

Date Accepted into CDER’s COA Qualification Program
August 5, 2015

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

--

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Transition Letter to 507 Process

9/5/19

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