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Nano-based drugs and medical devices : FDA's track record

Authors: Strickland, Cindy H.
Publication Type: Journal Article
Secondary Title: nanotechnology Law and Business
Abstract: This article looks at several medical products and drugs containing engineered nanomaterials that have been approved by the U.S. Food and Drug Administration (FDA), discusses the nature and extent of their FDA reviews, and makes som...
Year: 2007

Biblio - csep - 06/14/2010 - 11:29

Taking temperature–a review of European Union regulation in nanomedicine.

Authors: van Calster, Geert ; D'Silva, Joel
Publication Type: Journal Article
Secondary Title: European Journal of Health Law
Abstract: After introducing some of the current and future uses nanotechnology will have in healthcare applications, the authors discuss the current regulatory framework in the European Union that govern medical products, devices, biologics a...
Year: 2009
URL: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1285099

Biblio - csep - 08/25/2010 - 21:12

Regulating Nanomedicine - The Smallest of Our Concerns?

Authors: Brownsword, Roger
Publication Type: Journal Article
Secondary Title: NanoEthics
Abstract: Though discussion about the ethical issues that arise when looking at the medical applications of nanotechnology has mostly focused on the possibility of risks to human health, safety and the environment, the author of this article ...
Year: 2008
DOI: 10.1007/s11569-008-0030-2

Biblio - csep - 08/25/2010 - 20:57

Regulation of nanomedicines in the EU: distilling lessons from the pediatric and the advanced therapy medicinal products approaches

Authors: Chowdhury, Nupur
Publication Type: Journal Article
Secondary Title: Nanomedicine
Abstract: This article looks at the regulatory system in the European Union for pharmaceuticals, and the developments and innovations that have taken place guided by the philosophy of single market and balancing the principles of ensuring hig...
Year: 2010
DOI: 10.2217/nnm.09.91

Biblio - csep - 09/01/2010 - 09:53

The need for rules and regulations

Authors: Helmus, Michael
Publication Type: Journal Article
Secondary Title: Nature Nanotechnology
Abstract: After reviewing some of the recent and likely advances in the use of nanomaterials in medicine - such as in targeted drug delivery, diagnostics, and imaging- the author cites the need for standards and a updated regulatory framework...
Year: 2007
DOI: 10.1038/nnano.2007.165

Biblio - csep - 08/25/2010 - 20:58

European Regulatory Issues in Nanomedicine

Authors: Guerra, Giorgia
Publication Type: Journal Article
Secondary Title: NanoEthics
Abstract: In this article, the author analyzes the European Union...
Year: 2008
DOI: 10.1007/s11569-008-0031-1

Biblio - csep - 08/25/2010 - 20:58

Regulating Nanomedicine - Can the FDA Handle it?

Authors: Bawa, Raj
Publication Type: Journal Article
Secondary Title: Current drug delivery
Abstract: There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially tr...
Year: 2011

Biblio - csep - 02/07/2011 - 16:53

Regulating interface science healthcare products: myths and uncertainties.

Authors: Bravery, Christopher A
Publication Type: Journal Article
Secondary Title: Journal of the Royal Society, Interface / the Royal Society
Abstract: Whenever new technology emerges it brings with it concerns and uncertainties about whether or how it will need to be regulated, particularly when it is applied to human healthcare. Drawing on the recent history in the European Union...
Year: 2010
URL: http://rsif.royalsocietypublishing.org/content/7/Suppl_6/S789.abstract
DOI: 10.1098/​rsif.2010.0442.focus

Biblio - csep - 03/15/2011 - 10:37

A review of the current scientific and regulatory status of nanomedicines and the challenges ahead.

Authors: Hock, Sia Chong ; Ying, Yan Mei ; Wah, Chan Lai
Publication Type: Journal Article
Secondary Title: PDA journal of pharmaceutical science and technology / PDA
Abstract: Nanomedicines refer to drugs, medical devices, and health products developed using nanotechnology with the aim of diagnosing, monitoring, and treating diseases at the molecular level. Due to their nano size, nanomedicines offer adva...
Year: 2011
URL: http://journal.pda.org/content/65/2/177.abstract

Biblio - csep - 05/02/2011 - 13:53

International Harmonization of Regulation of Nanomedicine

Authors: Danforth, Tara Lynn ; Abbott, Kenneth W. ; Sylvester, Douglas J. ; Marchant, Gary E.
Publication Type: Journal Article
Secondary Title: Studies in Ethics, Law, and Technology
Abstract: Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nano-technologies generally, and nanomedical pro...
Year: 2009
URL: http://www.bepress.com/selt/vol3/iss3/art6/
DOI: 10.2202/1941-6008.1120

Biblio - csep - 09/12/2011 - 15:11