Regulatory and Clinical Outcomes of Nononcology Accelerated Approvals
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.
Authors
- Ian T. T. Liu
- Gemma K. Reynolds (ORCID: https://orcid.org/0000-0002-9561-3592)
- Aaron Seth Kesselheim (ORCID: https://orcid.org/0000-0002-8867-2666)
- Edward R. Scheffer Cliff (ORCID: https://orcid.org/0000-0001-5977-907X)
Institutions
- Brigham and Women's Hospital (US)
- The Royal Melbourne Hospital (AU)
- Harvard University (US)
- Peter MacCallum Cancer Centre (AU)
- University of Illinois Chicago (US)
- Austin Health (AU)
Publication Details
- Journal
- JAMA
- Published
- 2025-07-14
- DOI
- https://doi.org/10.1001/jama.2025.10726
- Citations
- 3
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 3.49