DDT COA #000080: PROMIS® Fatigue Item Bank for ME/CFS/SEID
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Rheumatology and Transplant Medicine (DRTM)
DDT COA Number
DDT COA #000080
Instrument Name
PROMIS® Fatigue Item Bank for ME/CFS/SEID
Disease/Condition
Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Systemic Exertion Intolerance Disease (SEID)
Concept of Interest
Fatigue
Context of Use
Patients with CFS, ME, or SEID
COA Type
PRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
San Keller
Contact(s)
San Keller
Date Accepted into CDER’s COA Qualification Program
October 8, 2015
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/5/19 |