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  6. DDT COA #000135: Cutaneous Lupus Erythematosus Disease Area and Severity Index in Systemic Lupus Erythematosus
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000135: Cutaneous Lupus Erythematosus Disease Area and Severity Index in Systemic Lupus Erythematosus

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

DDT COA Number
DDT COA #000135

Instrument Name
Cutaneous Lupus Erythematosus Disease and Severity Index (CLASI)

Disease/Condition
Systemic Lupus Erythematosus (SLE)

Concept of Interest
Presence and severity of signs of cutaneous manifestations

Context of Use
Patients with SLE

COA Type
ClinRO

Qualification Stage
Letter of Intent- Accepted

Requestor(s)
The CLASI Working Group

Contact(s)
Joseph Merola
Alyssa Parks
Victoria Werth

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

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent
Attachment A		 5/4/20 FDA Response (Accepted) 8/5/20
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