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DDT COA #000080: PROMIS® Fatigue Item Bank

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

DDT COA Number
DDT COA #000080

Instrument Name
PROMIS® Fatigue Item Bank

Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Systemic Exertion Intolerance Disease (SEID)

Concept of Interest

Context of Use
Patients with CFS, ME, or SEID

COA Type

Qualification Stage
In transition to 507 process 

San Keller

San Keller

Date Accepted into CDER’s COA Qualification Program
October 8, 2015

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