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 |
|---|---|---|---|
|
-- |
-- |
9/5/19 |
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