DDT COA #000111: Hidradenitis Suppurativa Quality of Life (HiSQOL)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Dermatology and Dentistry (DDD)
DDT COA Number
DDT COA #000111
Instrument Name
Hidradenitis Suppurativa Quality of Life (HiSQOL)
Disease/Condition
Hidradenitis Suppurativa (HS)
Concept of Interest
Symptom severity, limitations in performance of activities, and psychosocial effects
Context of Use
Adult patients with HS
COA Type
PRO
Qualification Stage
Letter of Intent- Accepted
Requestor(s)
Joslyn Kirby
Contact(s)
Joslyn Kirby
Date Accepted into CDER’s COA Qualification Program
May 14, 2019
Submission and Regulatory Correspondence History
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
2/4/19 |
5/14/19 |