组合产品：使监管模式现代化。
Combination products: modernizing the regulatory paradigm.
机构信息
Office of Medical Products and Tobacco, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
出版信息
Nat Rev Drug Discov. 2017 Aug;16(8):513-514. doi: 10.1038/nrd.2017.66. Epub 2017 May 12.
PMID:28496147
Abstract
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.
摘要
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。
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