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In this section: Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000085: PROMIS® Physical Functioning in Sarcopenia

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of General Endocrinology (DGE)

DDT COA Number
DDT COA #000085

Instrument Name
PROMIS® Physical Functioning in Sarcopenia

Disease/Condition
Sarcopenia

Concept of Interest
Physical functioning

Context of Use
Patients with sarcopenia

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
David Cella

Contact(s)
David Cella

Date Accepted into CDER’s COA Qualification Program
November 3, 2015

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
--	--	Transition Letter to 507 Process	9/5/19

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