Saha A, Hauber B. Introduction to and background of Patient-Preference Information (PPI). Presentation to be given at the Virtual ISPOR-FDA Summit 2020; September 29, 2020.


This session will provide an overview of PPI and the various terms referenced in this field. This will include a discussion on the fundamentals of how PPI differs from other types of patient-provided information and the different types of regulatory decisions that can be informed by PPI. A review of current regulatory documents that involve PPI, as well as an explanation of the quality measures considered by CDRH will be presented.

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