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  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000105: Actibelt® in Sarcopenia
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000105: Actibelt® 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 #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
DHT- Passive Monitoring COA

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 and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date

Letter of Intent

Appendix

9/20/18

FDA Response (Accepted)

1/18/19

 

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