DDT COA #000118: Hidradenitis Suppurativa Area and Severity Index (HASI)

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

DDT COA Number
DDT COA #000118

Instrument Name
Hidradenitis Suppurativa Area and Severity Index (HASI)

Disease/Condition
Hidradenitis Suppurativa (HS)

Concept of Interest
Disease severity and extent of active (inflamed) HS

Context of Use
Adult patients with HS

COA Type
ClinRO

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
Joslyn Kirby

Contact(s)
Joslyn Kirby

Date Accepted into CDER’s COA Qualification Program
June 11, 2019

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	3/19/19	FDA Response (Accepted)	6/11/19