title: Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems.
abstract: 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.
authors: Office of Science & Engineering Laboratories, Center for Devices & Radiological Health, USA.
authors: Kim E
authors: KE
authors: Sapsford
authors: Kristina
authors: K
authors: Lauritsen
authors: Katherine M
authors: KM
authors: Tyner
mesh_terms: D016503:Drug Delivery Systems; D004335:Drug and Narcotic Control; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration