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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...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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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 |