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  5. DDT COA #000111: Hidradenitis Suppurativa Quality of Life (HiSQOL)
  1. Drug Development Tool Qualification Programs

DDT COA #000111: Hidradenitis Suppurativa Quality of Life (HiSQOL)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) III
Division of Dermatology and Dental Products (DDDP)

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

Letter of Intent

2/4/19

FDA Response (Accepted)

5/14/19

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