Gene Therapy FDA Ethics Term Paper

Pages: 2 (892 words)  ·  Style: MLA  ·  Bibliography Sources: 2  ·  File: .docx  ·  Level: College Senior  ·  Topic: Genetics

"Gene therapy is a medical intervention based on modification of the genetic material of living cells. Cells may be modified ex-vivo for subsequent administration to humans, or may be altered in vivo by gene therapy given directly to the subject. When the genetic manipulation is performed ex-vivo on cells which are then administered to the patient, this is also a form of somatic cell therapy. The genetic manipulation may be intended to have a therapeutic or prophylactic effect, or may provide a way of marking cells for later identification. Recombinant DNA materials used to transfer genetic material for such therapy are considered components of gene therapy and as such are subject to regulatory oversight." (Murphy, p3)

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New drugs and medical techniques that wish to receive approval have to go through many steps to final market acceptance. On e overseer of the gene therapy process is the CBER which stands for the Center for Biologics Evaluation and Research. Their main function is to regulate all human gene therapy products. This entails all products made that introduce any type of genetic material into a human body with the intent of replacing some faulty or missing genetic material. The objective of this process must currently be to treat or cure a disease or abnormal medical condition. CBER has at its disposal various legal means to help it such as the 'Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.' "All gene therapy products and most somatic cell therapy products are regulated by the FDA. See "A Proposed Approach to the Regulation of Cellular and Tissue-Based Products," February 28, 1997, (62 FR 9721) as well as subsequent regulations and policy issued in this area." (Murphy) The FDA has not approved human gene therapy products for free market sale but there is currently so much gene-related research and development occurring throughout the United States and the world that the FDA has had to incorporate all new process to verify that legal mandates are being followed by all involved in this potential trillion dollar industry.


Term Paper on Gene Therapy FDA Ethics Can Assignment

Brannigan, Michael C. Ethical Issues in Human Cloning: Cross-Disciplinary Perspectives. New York, NY: Seven Bridges Press, LLC, 2000.

Food and Drug Administration. "Cellular & Gene Therapy Products." Retrieved on December 7, 2009, from FDA at:

Murphy, Dano B.. "Guidance for Industry: Guidance for Human Somatic Cell, Therapy and Gene Therapy." U.S. Department of Health and Human Services, Food and Drug, Center for Biologics Evaluation and… [END OF PREVIEW] . . . READ MORE

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How to Cite "Gene Therapy FDA Ethics" Term Paper in a Bibliography:

APA Style

Gene Therapy FDA Ethics.  (2009, December 8).  Retrieved April 12, 2021, from

MLA Format

"Gene Therapy FDA Ethics."  8 December 2009.  Web.  12 April 2021. <>.

Chicago Style

"Gene Therapy FDA Ethics."  December 8, 2009.  Accessed April 12, 2021.