Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022

Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022

Abstract Background The Food and Drug Administration (FDA)’s Accelerated Approval (AA) pathway has increasingly used to authorize market approval of new drugs amid controversy. The present study aims to inform the most recent data on the strength of clinical evidence supporting such approvals. Metho...

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Bibliographic Details
Main Authors: Xiaofang Zhang, Carl C. Peck, Yaning Wang, Thomas D. Szucs, Wan Sun, Xue Bai, Siyu Chen, Fengzhi Wang, Yangfeng Wu
Format: Article
Language:English
Published: BMC 2024-12-01
Series:BMC Medicine
Subjects:
Accelerated approval
Strength of clinical evidence
Trend over time
Regulatory science
Online Access:https://doi.org/10.1186/s12916-024-03800-6
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