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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

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

Qualification Stage
Letter of Intent-Accepted

Pam Wolters

Pam Wolters

Date Accepted into CDER’s COA Qualification Program
March 6, 2014

Submission and Regulatory Correspondence History

Qualification Submission


FDA Submission Decision & Recommendations




Transition Letter to 507 Process


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