Taking AIM at serious illness: implementing an access to investigational medicines expanded access program

When seriously ill patients have exhausted all treatment options available as part of usual care, the use of investigational agents may be warranted. Food and Drug Administration’s (FDA) Expanded Access (EA) pathway provides a mechanism for these patient’s physicians to pursue use of an investigatio...

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Autori principali:	Meghan Morrison Joly, Terri L. Edwards, Rebecca N. Jerome, Alex Mainor, Gordon R. Bernard, Jill M. Pulley
Natura:	Artigo
Lingua:	Inglês
Pubblicazione:	Frontiers Media S.A. 2023-10-01
Serie:	Frontiers in Medicine
Soggetti:	FDA expanded access compassionate use single patient IND investigational medicines access to investigational medicines regulatory knowledge
Accesso online:	https://www.frontiersin.org/articles/10.3389/fmed.2023.1287449/full
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