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  5. DDT COA #000118: Hidradenitis Suppurativa Area and Severity Index (HASI)
  1. Drug Development Tool Qualification Programs

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

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

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

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