Scientific Publications by FDA Staff
Ther Deliv 2012 Dec;3(12):1383-94
Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems.
Sapsford KE, Lauritsen K, Tyner KM
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.
|Category: Journal Article, Editorial|
|PubMed ID: #23323557||DOI: 10.4155/tde.12.119|
|Includes FDA Authors from Scientific Area(s): Medical Devices Drugs Women's Health|
|Entry Created: 2013-01-18||Entry Last Modified: 2014-11-18|