New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible

中文翻译：

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组合产品：现代化的监管范式

结合药物，设备和/或生物成分开发创新产品（通常是复杂产品）的新机会正在迅速出现，这引发了有关如何监管此类产品的疑问。在这里，我们讨论了FDA为开发现代，透明，灵活的产品所做的持续努力