基因编辑:调控视角

Sarfaraz K. Niazi
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引用次数: 0

摘要

基因或基因组编辑,通常被称为GE,是一种在DNA水平上用于修改、消除或替代突变基因的技术。它是基因操作领域的一个有价值的工具。基因治疗(GT)是一种旨在通过将功能基因拷贝送入体内来纠正突变的治疗方法。相反,突变的基因保留在基因组中。它被认为是一种医疗干预形式。GE生产的任何产品都没有获得批准,而GT生产的22种药物获得了批准。这些GT产品的价格为每剂数百万美元。美国食品药品监督管理局(FDA)最近实施了一项关于基因编辑的指导方针,旨在促进基因工程(GE)产品的快速创造。然而,FDA必须提供进一步的说明和必要的修订,以增强该指南的合理性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Gene Editing: The Regulatory Perspective
Gene or genome editing, often known as GE, is a technique utilized to modify, eliminate, or substitute a mutated gene at the DNA level. It serves as a valuable tool in the field of genetic manipulation. Gene therapy (GT) is a therapeutic approach that aims to correct mutations by delivering a functional gene copy into the body. In contrast, the mutated gene remains in the genome. It is considered a form of medical intervention. No approval has been granted for any product manufactured by GE, in contrast to the approval of 22 medications produced by GT. These GT products are priced at millions of US dollars each dose. The Food and Drug Administration (FDA) has recently implemented a guideline about gene editing, which aims to facilitate the expedited creation of genetically engineered (GE) goods. However, the FDA must provide further elucidation and necessary revisions to enhance the rationality of this guideline.
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