DDT COA #000075: Polycystic Liver Disease Questionnaire (PLD-Q)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Hepatology and Nutrition (DHN)
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 |
|---|---|---|---|
|
-- |
-- |
9/5/19 |