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
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