Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications

Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications. The publicly accessible SE Table was first published in 2018 as a response to the 21st Century Cures Act legislation and is...

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Autores principales:	Abena S. Agyeman, Jeffrey N. Siegel, Christopher Leptak
Formato:	Artigo
Lenguaje:	Inglês
Publicado:	Frontiers Media S.A. 2022-02-01
Colección:	Frontiers in Medicine
Materias:	surrogate endpoint 21st Century Cures Act accelerated approval traditional approval biomarker validated surrogate endpoint
Acceso en línea:	https://www.frontiersin.org/articles/10.3389/fmed.2022.820990/full
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