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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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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