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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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Detalles Bibliográficos
Autores principales: Agyeman, Abena S., Siegel, Jeffrey N., Leptak, Christopher
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8894669/
https://www.ncbi.nlm.nih.gov/pubmed/35252258
http://dx.doi.org/10.3389/fmed.2022.820990