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DDT COA #000080: PROMIS® Fatigue Item Bank for ME/CFS/SEID

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 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

--

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Transition Letter to 507 Process

9/5/19

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