Building on the successes of patient-focused drug development: a call for new policies to maintain momentum

Since its commencement as part of the Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA) V in 2012, patient-focused drug development (PFDD) has become an integral part of the drug development paradigm. FDA encourages the development and use of Patient-Experience Data (PED) a...

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Bibliographic Details

Published in:	Frontiers in Medicine
Main Authors:	Allison Martin, Victoria DiBiaso, Mladen Bozic, Alexander T. May
Format:	Article
Language:	English
Published:	Frontiers Media S.A. 2024-10-01
Subjects:	patient-focused drug development patient experience data Food and Drug Administration PDUFA regulatory decision making benefit–risk
Online Access:	https://www.frontiersin.org/articles/10.3389/fmed.2024.1416123/full