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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Hlavní autoři:	Meghan Morrison Joly, Terri L. Edwards, Rebecca N. Jerome, Alex Mainor, Gordon R. Bernard, Jill M. Pulley
Médium:	Artigo
Jazyk:	Inglês
Vydáno:	Frontiers Media S.A. 2023-10-01
Edice:	Frontiers in Medicine
Témata:	FDA expanded access compassionate use single patient IND investigational medicines access to investigational medicines regulatory knowledge
On-line přístup:	https://www.frontiersin.org/articles/10.3389/fmed.2023.1287449/full
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