National landscape assessment of academic medical center support for expanded access to investigational products.
Journal of clinical and translational science(2023)
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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