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 (P...

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Bibliographic Details
Published in:Frontiers in medicine 2024-10, Vol.11, p.1416123
Main Authors: Martin, Allison, DiBiaso, Victoria, Bozic, Mladen, May, Alexander T
Format: Article
Language:English
Subjects:
benefit–risk
Food and Drug Administration
patient experience data
patient-focused drug development
PDUFA
regulatory decision making
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Summary: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) as it provides important information on the patients' needs and perspectives and inform regulatory decision-making. While the FDA is required to fill out a table which includes a list of various types of Patient Experience Data (PED) and if such data was reviewed by FDA as part of a drug application, there is still a need to understand how FDA uses PED in its regulatory decision-making. This article examines whether new policies are needed to ensure the full potential of PFDD.
ISSN:2296-858X
2296-858X
DOI:10.3389/fmed.2024.1416123