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Regulatory Pathways Emerge For Gene-Edited Products

Law360, New York (March 20, 2017, 12:26 PM EDT) -- Emily Marden

Deepti A. Kulkarni There has long been uncertainty about when and how regulators would respond to emerging genetic technologies such as gene editing, as the current U.S. regulatory system was not designed to address these technologies. Under the current system, it is unclear whether products developed through the use of these new technologies fall within the scope of regulation and what factors, if any, should be considered to assess risk. This ambiguity has raised issues for a range of innovators who are quickly adopting...
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