Laws & Regulations
In the US, the Federal government Food and Drug Administration (FDA) has regulated human tissue intended for transplants since 1993. In order to ensure the quality of donor tissue and reduce contamination and disease transmission risks three regulations addressing manufacturing activities associated with human cells, tissues, and cellular and tissue-based products (HCT/Ps) were promulgated in May 2005: The first requires companies producing and distributing HCT/Ps to register with the FDA. The second, called the “Donor Eligibility” rule, proscribes criteria for donor eligibility. The third, the “Current Good Tissue Practices” rule, oversees overall processing and distribution practices of each company.
Read more about this topic: Allogeneic Stem Cell Transplantation
Famous quotes containing the words laws and/or regulations:
“The best laws cannot make a constitution work in spite of morals; morals can turn the worst laws to advantage. That is a commonplace truth, but one to which my studies are always bringing me back. It is the central point in my conception. I see it at the end of all my reflections.”
—Alexis de Tocqueville (1805–1859)
“If it were possible to make an accurate calculation of the evils which police regulations occasion, and of those which they prevent, the number of the former would, in all cases, exceed that of the latter.”
—Karl Wilhelm Von Humboldt (1767–1835)