Document Detail


Taking temperature--a review of European Union regulation in nanomedicine.
MedLine Citation:
PMID:  19788003     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Nanomedicine, the application of nanotechnology to healthcare offers numerous improvements to medical diagnosis, drug delivery, therapy and implants. The potential impact of nanomedicine is foreseen radically to change health care; however it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance. This paper introduces the emerging field of nanomedicine and then proceeds to detail the current regulatory framework and regulatory bodies in the European Union relating to medicinal products, medical devices, biologics and therapies. This is followed by a detailed analysis of two nanomedical applications in the context of regulatory challenges. The paper concludes with a discussion of the adequacy of the current regulatory regime in Europe and where problems are likely to arise as nanomedicine evolves.
Authors:
Joel D'Silva; Geert van Calster
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  European journal of health law     Volume:  16     ISSN:  0929-0273     ISO Abbreviation:  Eur J Health Law     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-09-30     Completed Date:  2009-10-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9431861     Medline TA:  Eur J Health Law     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  249-69     Citation Subset:  IM    
Affiliation:
Faculty of Law, K.U. Leuven, Belgium. joel.dsilva@law.kuleuven.be
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MeSH Terms
Descriptor/Qualifier:
European Union
Government Regulation
Humans
Nanomedicine / legislation & jurisprudence*,  trends

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