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. 2024 Nov 11;42(11):1799-1802.
doi: 10.1016/j.ccell.2024.09.005. Epub 2024 Oct 10.

Accelerated approvals: Early-phase success or premature authorization?

Xiangyun Mao  1 , G Caleb Alexander  2 , Guanqiao Li  3
Affiliations

Accelerated approvals: Early-phase success or premature authorization?

Xiangyun Mao et al. Cancer Cell. .

Abstract

We compare the clinical trial success rates of products receiving US Food and Drug Administration (FDA) accelerated approval (AA) to those approved without using this pathway. Our findings raise important questions about how the AA pathway can best optimize early access to therapeutics that are ultimately proven safe and effective.

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Conflict of interest statement

Declaration of interests G.C.A. is past chair of the FDA’s Peripheral and Central Nervous System Advisory Committee and a co-founding principal and equity holder in Stage Analytics. These arrangements have been reviewed and approved by Johns Hopkins University in accordance with its conflict-of-interest policies.

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