DDT COA #000061: Plexiform Neurofibroma Impact in Children & Adults
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Oncologic Diseases (OOD)
Division of Oncology 1 (DO1)
DDT COA Number
DDT COA #000061
Instrument Name
Plexiform Neurofibroma Pain Impact in Children & Adults
Disease/Condition
Plexiform neurofibroma (PN)
Concept of Interest
Tumor-related pain intensity, pain interference, and physical functioning
Context of Use
Children (>5 years) and adults with neurofibromatosis type 1 (NF1) and PN
COA Type
PRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Pam Wolters
Contact(s)
Pam Wolters
Date Accepted into CDER’s COA Qualification Program
March 6, 2014
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/5/19 |