DDT COA #000126: Functional Vision Questionnaire (FVQ) PRO

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Specialty Medicine (OSM)
Division of Ophthalmology (DO)

DDT COA Number
DDT COA #000126

Instrument Name
Functional Vision Questionnaire (FVQ) PRO

Disease/Condition
Retinitis Pigmentosa

Concept of Interest
Visual function and functional vision

Context of Use
Adolescents (12-17 years) and adults (>18 years) with a clinical and genetic confirmed diagnosis of RP

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted

Requestor(s)
Novartis Pharmaceuticals Corporation

Contact(s)
Orin Tempkin

Date Accepted into CDER’s COA Qualification Program
June 5, 2020

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	3/18/20	FDA Response (Accepted)	6/5/20