Bibliographic Details
| Title: |
Building on the successes of patient-focused drug development: a call for new policies to maintain momentum |
| Authors: |
Allison Martin, Victoria DiBiaso, Mladen Bozic, Alexander T. May |
| Source: |
Frontiers in Medicine, Vol 11 (2024) |
| Publisher Information: |
Frontiers Media S.A., 2024. |
| Publication Year: |
2024 |
| Collection: |
LCC:Medicine (General) |
| Subject Terms: |
patient-focused drug development, patient experience data, Food and Drug Administration, PDUFA, regulatory decision making, benefit–risk, Medicine (General), R5-920 |
| More Details: |
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. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2296-858X |
| Relation: |
https://www.frontiersin.org/articles/10.3389/fmed.2024.1416123/full; https://doaj.org/toc/2296-858X |
| DOI: |
10.3389/fmed.2024.1416123 |
| Access URL: |
https://doaj.org/article/6b0d2edc02bd4ec89e8bc667e5fcc799 |
| Accession Number: |
edsdoj.6b0d2edc02bd4ec89e8bc667e5fcc799 |
| Database: |
Directory of Open Access Journals |
