U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000085: PROMIS® Physical Functioning in Sarcopenia
  1. 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

 

 
Back to Top