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

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

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