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FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.
Food Drug Law J. 2016; 71(4):608-33.FD

Abstract

Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29140647

Citation

Grant, Evita V.. "FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology." Food and Drug Law Journal, vol. 71, no. 4, 2016, pp. 608-33.
Grant EV. FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology. Food Drug Law J. 2016;71(4):608-33.
Grant, E. V. (2016). FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology. Food and Drug Law Journal, 71(4), 608-33.
Grant EV. FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology. Food Drug Law J. 2016;71(4):608-33. PubMed PMID: 29140647.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology. A1 - Grant,Evita V, PY - 2016/1/1/pubmed PY - 2017/12/8/medline PY - 2017/11/16/entrez SP - 608 EP - 33 JF - Food and drug law journal JO - Food Drug Law J VL - 71 IS - 4 N2 - Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations. SN - 1064-590X UR - https://www.unboundmedicine.com/medline/citation/29140647/FDA_Regulation_of_Clinical_Applications_of_CRISPR_CAS_Gene_Editing_Technology_ DB - PRIME DP - Unbound Medicine ER -