The implications of "advanced therapies" regulation.
Recent policy developments in the United States and Europe have created new regulatory regimes for advanced and complex treatments such as cell therapies, tissue engineering, and gene therapies that are of particular relevance for regenerative medicine. Where these new legal rules operate as a mere extension of existing regimes, they risk stifling innovation in these areas of life extension technology.
Sethe
Sebastian C
SC
Northeast England Stem Cell Institute, Durham, UK. legal@nesci.ac.uk
D017277:Drug Approval; D005060:Europe; D033161:Government Regulation; D006801:Humans; D011050:Policy Making; D011639:Public Opinion; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence* / Q000379:methods / Q000639:trends; D035703:Therapies, Investigational / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration