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  6. DDT COA #000130: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Cutaneous Lupus Erythematosus
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000130: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Cutaneous 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 #000130

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

Disease/Condition
Cutaneous Lupus Erythematosus (CLE)

Concept of Interest
Presence and severity of signs of CLE

Context of Use
Patients with CLE

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
July 13, 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) 7/13/20
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