U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. DDT COA #000037: Short Physical Performance Battery (SPPB)
  1. Drugs

DDT COA #000037: Short Physical Performance Battery (SPPB)

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

DDT COA Number
DDT COA #000037

Instrument Name
Short Physical Performance Battery (SPPB)

Disease/Condition
Hip fracture

Concept of Interest
Lower-extremity functional decline

Context of Use
Adult patients (>65 years) who have diminished muscle mass, muscle strength and decreased function as a result of hip fracture

COA Type
PerfO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Aging in Motion Coalition of the Alliance for Aging Research

Contact(s)
Ryne Carney
Jack Guralnik

Date Accepted into CDER’s COA Qualification Program
January 3, 2014

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

   

Transition Letter to 507 Process

9/5/19

Back to Clinical Outcome Assessments (COA) Qualification Submission