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  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000120: Scratch Sensor

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Dermatology and Dentistry (DDD)

DDT COA Number
DDT COA #000120

Instrument Name
Scratch Sensor

Disease/Condition
Atopic dermatitis

Concept of Interest
Itch intensity and persistence

Context of Use
Patients > 2 years with atopic dermatitis

COA Type
DHT- Passive Monitoring COA

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Steve Xu

Contact(s)
Steve Xu

Date Accepted into CDER’s COA Qualification Program
December 26, 2020

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 9/12/19 FDA Response (Accepted) 1/7/20
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