Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023
Given the rising number of the Food and Drug Administration approvals based on a single pivotal trial, greater clarity on confirmatory evidence standards and communication of its use could be considered.
Authors
- Reshma Ramachandran (ORCID: https://orcid.org/0000-0003-3845-3606)
- Joseph S. Ross (ORCID: https://orcid.org/0000-0002-9218-3320)
- Carla Godoy (ORCID: https://orcid.org/0000-0002-4025-4633)
- Pradyumna Sapre
Institutions
- Yale New Haven Hospital (US)
- Yale University (US)
- Yale New Haven Health System (US)
Publication Details
- Journal
- Clinical Trials
- Published
- 2025-10-15
- DOI
- https://doi.org/10.1177/17407745251376620
- Citations
- 2
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 6.26