Accelerated approval drug labels often lack information for clinical decision-making.

Jeromie Ballreich,Mariana Socal,Charles L Bennett,Andrew Xuan,Antonio Trujillo, Gerard Anderson

Pharmacotherapy（2023）

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摘要

Labels for accelerated approved clinical indications that do not yet have full approval should be revised to include the information required in the FDA guidance to help guide clinical decision-making.

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关键词

FDA,accelerated approval,ethics,industry,public health,surrogate markers

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