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DDT COA #000075: Polycystic Liver Disease Questionnaire (PLD-Q)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) III
Division of Gastroenterology and Inborn Error Products (DGIEP)

DDT COA Number
DDT COA #000075

Instrument Name
Polycystic Liver Disease Questionnaire (PLD-Q)

Disease/Condition
Polycystic Liver Disease (PLD)

Concept of Interest
PLD symptoms

Context of Use
Adult patients with Gigot stage II or III PLD

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Marie Hogan
Jeff Sloan

Contact(s)
Marie Hogan

Date Accepted into CDER’s COA Qualification Program
February 8, 2016

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

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