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News and Press: Policy News

White House to Update Biotechnology Framework

Thursday, July 16, 2015   (0 Comments)
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The White House Office of Science and Technology Policy (OSTP) directed the FDA, USDA, and EPA to “improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system.”

The review will consist of three elements: 

1. An update to the Coordinated Framework for the Regulation of Biotechnology that will “help clarify which biotechnology product areas are within the authority and responsibility of each agency.” 

2. Development of a “long-term strategy to ensure that the system is prepared for the future products of biotechnology.” 

3.Conduct of “an expert analysis of the future landscape of biotechnology products” by the National Academies of Sciences, Engineering, and Medicine.   

The Coordinated Framework hasn’t been updated since 1992. A review is prudent given the changes in the biotechnology product landscape and a proliferation of regulations and guidance documents by federal regulatory agencies.

It’s likely that the directive will have an impact on regulation of bioengineered foods, but not on human drugs and medical devices because those products are not the focus of the activities described in the OSTP memorandum.

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