New rules to assess the safety and efficacy of human cell- and tissue-based products are the culmination of a multiyear, cooperative effort between the US government and the biotech industry.
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Department of Health and Human Services, Food and Drug Administration. Human cells, tissues, and cellular and tissue-based; donor screening and testing; and related labeling. Fed. Regist. 70, 29949–29952 (2005). <http://reform.house.gov/UploadedFiles/FDA%20Regulation%2021%20CFR%201271.pdf>
Department of Health and Human Services, Food and Drug Administration. Application of current statutory authorities to human somatic cell therapy products and gene therapy products, Docket 93N-0173. Fed. Regist. 58, 53248–53251 (1993). <http://www.fda.gov/cber/genadmin/fr101493.pdf>
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Preti, R. Bringing safe and effective cell therapies to the bedside. Nat Biotechnol 23, 801–804 (2005). https://doi.org/10.1038/nbt0705-801
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DOI: https://doi.org/10.1038/nbt0705-801
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