U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. DDT COA #000079: PROMIS® Physical Function in Oncology
  1. Drugs

DDT COA #000079: PROMIS® Physical Function in Oncology

Office of Oncologic Diseases (OOD)

DDT COA Number
DDT COA #000079

Instrument Name
PROMIS® Physical Function in Oncology

Disease/Condition
Cancer

Concept of Interest
Physical functioning

Context of Use
Adult patients (> 18 years) with solid tumors or hematologic malignancies with a performance status range 0-3 and receiving active anti-cancer therapy

COA Type
PRO

Qualification Stage
Qualification Plan- 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

Qualification Plan

10/11/19

FDA Response (Accepted)

2/10/20

Back to Top