Articles with "establishing public" as a keyword



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

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Published in 2022 at "Frontiers in Medicine"

DOI: 10.3389/fmed.2022.820990

Abstract: 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… read more here.

Keywords: surrogate endpoints; establishing public; acceptable surrogate; marketing applications ... See more keywords