Office of Medical Products and Tobacco, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Nat Rev Drug Discov. 2017 Aug;16(8):513-514. doi: 10.1038/nrd.2017.66. Epub 2017 May 12.
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 and consistent science-based regulatory approach for combination products.
新的机会正在涌现，使人们能够开发创新的——而且往往是复杂的——药物、设备和/或生物成分相结合的产品，这引发了关于此类产品应如何监管的问题。在这里，我们讨论了 FDA 为开发一种现代、透明、灵活和一致的基于科学的组合产品监管方法所做的持续努力。
