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FDA Regulation of Human Reproductive Cloning: A Technology in Search of a Niche

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Publication Date: December 2004

Publisher(s): Food and Drug Law Institute (U.S.)

Author(s): Kathy Hudson; Gail Javitt

Topic: Health (Medical research and technology)

Keywords: FDA regulation; Reproductive genetics; Cloning; Genetics

Type: Other

Coverage: United States


Since 1998, the Food and Drug Administration (FDA) has stated publicly that it has jurisdiction to regulate human reproductive cloning. Consistent with this position, the agency sent letters to researchers informing them of the need to submit an investigational new drug (IND) application before clinical efforts to clone a human being. Further, FDA has stated that, because human reproductive cloning raises currently unresolved safety concerns, the agency will not approve such an application until those concerns are addressed appropriately. In this way, FDA, in effect, has banned human reproductive cloning.