Engineering human tissue and regulation: confronting biology and law to bridge the gaps.
There are a number of difficulties confronting the regulation of human tissue engineered products, from the scientific, ethical and legal perspectives. Many of these issues are international in scope and any responses must consider the global implications of marketing and monitoring these products. The article argues that as tissue engineered products become more available regulatory authorities should not be pressured into adopting possibly inappropriate measures, but must consider all the factors relevant to human health, including the need for innovative regulatory mechanisms as well as innovative tissue products themselves.
Longley
D
D
Sheffield Institute of Biotechnological Law and Ethics, University of Sheffield, UK.
Lawford
P
P
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D005060:Europe; D033161:Government Regulation; D006801:Humans; D007883:Legislation, Medical; D023822:Tissue Engineering / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration