Original paper

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals

Volume: 54, Issue: 3, Pages: 709 - 716
Published: Jan 6, 2020
Abstract
“Patient experience data” (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment traditional clinical trial data in the FDA’s review of product applications. Section 3001 of the 2016 21st Century Cures Act requires the FDA to make a public statement about the PED considered in the approval of a drug application. Here, we present one of the first...
Paper Details
Title
FDA Reported Use of Patient Experience Data in 2018 Drug Approvals
Published Date
Jan 6, 2020
Volume
54
Issue
3
Pages
709 - 716
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