Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems

被引：0
|
作者：
Sapsford, Kim E. [1 ]
Lauritsen, Kristina [2 ]
Tyner, Katherine M. [3 ]
机构：
[1] US FDA, Ctr Devices & Radiol Hlth, Off Sci & Engn Labs, Rockville, MD 20857 USA
[2] US FDA, Off Commissioner, Off Combinat Prod, Rockville, MD 20857 USA
[3] US FDA, Ctr Drug Evaluat & Res, Off Testing & Res, Rockville, MD 20857 USA
来源：
THERAPEUTIC DELIVERY | 2012年 / 3卷 / 12期
关键词：
D O I：
10.4155/TDE.12.119
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The US FDA is the US agency responsible for regulating intelligent drug- delivery systems (IDDS). IDDS can be classified as a device, drug, biologic or combination product. In this perspective, the current regulatory framework for IDDS and future perspectives on how the field is expected to evolve from a regulatory standpoint is discussed.
引用
收藏
页码：1383 / 1394
页数：12
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