Donawa M
Med Device Technol. 2001 Jun;12(5):25-8.
If the United States (US) Food and Drug Administration (FDA) receives the funding that it has requested, it plans to increase inspections of clinical investigation sites both in the US and abroad. This article discusses US clinical investigation requirements and guidance documents that should be reviewed when preparing for FDA clinical site inspections.
如果美国食品药品监督管理局（FDA）获得其申请的资金，它计划增加对美国国内外临床研究场所的检查。本文讨论了在美国食品药品监督管理局临床场所检查准备过程中应查阅的美国临床研究要求和指导文件。
