National landscape assessment of academic medical center support for expanded access to investigational products.

Misty Gravelin,Joan E Adamo, Sharon Ellison,Erika Segear,Amanda B Parrish, Christine Deeter, Jennifer Hamill, Laurie Rigan,George A Mashour,Kevin J Weatherwax

Journal of clinical and translational science(2023)

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摘要
Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.
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关键词
CTSA,Expanded access,academic medical centers,compassionate use,investigational drugs,investigational medical devices
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