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  1. Development & Approval Process (Drugs)

DDT COA #000105: Actibelt® in Sarcopenia

DDT COA #000105: Actibelt® 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 #000105

Instrument Name
Actibelt® in Sarcopenia

Disease/Condition
Sarcopenia

Concept of Interest
change in real-world walking speed

Context of Use
Patients with sarcopenia in recovery after surgical treatment of hip fracture

COA Type
Other

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
Martin Daumer

Contact(s)
Martin Daumer

Date Accepted into CDER’s COA Qualification Program
January 18, 2019

Submission History

Qualification Submission Date Deemed Reviewable FDA Submission Decision & Recommendations Date

Letter of Intent

Appendix

9/20/18

FDA Response (Accepted)

1/18/19

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