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  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000117: Network/Function Assessment of Cancer Therapy- Disease Related Symptom Scale (NFKSI-DRS)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000117: Network/Function Assessment of Cancer Therapy- Disease Related Symptom Scale (NFKSI-DRS)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Oncologic Diseases (OOD)
Division of Oncology 1 (DO1)

DDT COA Number
DDT COA #000117

Instrument Name
Network/Function Assessment of Cancer Therapy- Disease Related Symptom Scale (NFKSI-DRS)

Disease/Condition
Renal cell carcinoma (RCC)

Concept of Interest
Disease-related symptoms of RCC

Context of Use
Adult patients (>18 years) with advanced or metastatic (AJCC stage IV) RCC

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
FACIT.org through Northwestern University

Contact(s)
David Cella

Date Accepted into CDER’s COA Qualification Program
August 19, 2019

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Letter of Intent

5/20/19

FDA Response (Accepted)

8/16/19
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