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DDT COA #000057: Sickle Cell Pain Diary

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Hematology and Oncology Products (OHOP)

DDT COA Number
DDT COA #000057

Instrument Name
Sickle Cell Pain Diary

Disease/Condition
Sickle Cell Disease (SCD)
Concept of Interest
Pain intensity and pain interference

Context of Use
Pediatric patients with SCD

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Lakshmanan Krishnamurti

Contact(s)
Lakshmanan Krishnamurti

Date Accepted into CDER’s COA Qualification Program
February 14, 2014

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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