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DDT COA #000061: Plexiform Neurofibroma Impact in Children & Adults

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Hematology and Oncology Products (OHOP)
Division of Oncology Products 2 (DOP 2)

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

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Transition Letter to 507 Process

9/5/19

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