U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000118: Hidradenitis Suppurativa Area and Severity Index (HASI)
  1. Clinical Outcome Assessment (COA) Qualification Program

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
Back to Top