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DDT COA #000085: PROMIS® Physical Functioning Item Bank in Sarcopenia

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Metabolism and Endocrinology Products (DMEP)

DDT COA Number
DDT COA #000085

Instrument Name
PROMIS® Physical Functioning Item Bank 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

--

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Transition Letter to 507 Process

9/5/19

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