Regulatory and Clinical Outcomes of Nononcology Accelerated Approvals
- Author(s)
- Liu, ITT; Reynolds, G; Kesselheim, AS; Cliff, ERS;
- Journal Title
- JAMA
- Publication Type
- Online publication before print
- Abstract
- This study uses US Food and Drug Administration (FDA) data to characterize pivotal and confirmatory trials supporting agency decision-making in the context of the FDA accelerated approval pathway for nononcology products.; eng
- Department(s)
- Infectious Diseases; Haematology
- Publisher's Version
- https://doi.org/10.1001/jama.2025.10726
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-07-31 02:10:25
Last Modified: 2025-07-31 02:10:50