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DDT COA #000027: A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

DDT COA Number
DDT COA #000027

Instrument Name
A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)

Disease/Condition
Idiopathic pulmonary fibrosis (IPF)

Concept of Interest
Symptom experience, daily functioning and other health-related quality of life impacts

Context of Use
Adult patients (>18 years) with IPF

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
National Jewish Health

Contact(s)
Chris Evans

Date Accepted into CDER’s COA Qualification Program
January 25, 2012

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

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Transition Letter to 507 Process

9/5/19

Back to Clinical Outcome Assessments (COA) Qualification Submission