In a world first, a Chinese team led by Dr. Junjiu Huang at Sun Yat-Sen University in Guangzhou have reported editing the genomes of human embryos and the results are published in the journal Protein and Cell in ________; 6(5):363-372.
A. 2011
B. 2013
C. 2015
D. 2017
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The recent approvals of gene therapeutic agents by the Food and Drug Administration (FDA) in the United States are milestones in the field of gene therapy and raise hope for many patients suffering from ________ diseases (usually rare genetic diseases) as well as many other more common illnesses.
A. complicated
B. individual
C. unique
D. orphan
Safety of the ______________ and future generations is a major concern for human germline gene editing.
A. parents
B. child
C. family members
D. attending physicians
Researchersaretestingseveralapproachestogenetherapy,including:
A. replacingamutatedgenethatcausesthediseasewithahealthycopyofthegene
B. inactivating,or"knockingout,"amutatedgenethatisfunctioningimproperly
C. introducinganewgeneintothebodytohelpfightadisease
D. usingantibodies
How does US FDA regulate gene therapy products?
A. Comprehensive federal laws, regulations, & guidelines help protect people who participate in clinical trials. The US FDA regulates all gene therapy products in the United States & oversees research in this area.
B. FDA's regulation includes scientific review, regulatory research, testing, & compliance activities (inspection & education). Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA.
C. The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. As with other kinds of drugs, FDA regulates the quality & safety of gene therapy products and supervises how these products are used clinically.
D. Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects, such as clinical trials, must be reviewed & approved by the FDA and an Institutional Review Board.
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