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White House Calls for Modernization of Biotechnology Regulations

August 04, 2015
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Biotechnological innovation is potentially subject to a variety of governmental regulations. For example, therapeutics for disease treatment or prevention in humans are subject to review and approval by the Food and Drug Administration (FDA). Innovations relating to crops or livestock may be subject to the Department of Agriculture (USDA). However, the regulations promulgated by these governmental agencies are all based on a Coordinated Framework established by the Office of Science and Technology Policy, which was last updated in 1992. Recognizing that the Coordinated Framework, and the regulations based thereon, are in need of a significant update, the White House issued a memorandum on July 2, 2015, initiating "a process to modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system.‚¬ 

Among the stated goals of the initiative are clarifying the roles and responsibilities of the various agencies that regulate the products of biotechnology, including which biotechnology product areas are within the authority and responsibility of each agency, and how the various agencies interact within biotechnology areas.

Given the enormous amount of innovation that has occurred since the last update to the Common Framework in 1992, this initiative has the potential to bring the numerous governmental regulations in the biotechnology sector into closer alignment with scientific reality.  In addition, the initiative specifically calls for input from the public, providing an opportunity for those involved in biotechnology innovation to help shape the future of regulations in this area.

The full memorandum is available here.


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