White House releases coordinated summary for all US biotechnology regulation


Editor’s Note: The following is a portion of the coordinated summary released by the White House outlining the Coordinated Framework for the Regulation of Biotechnology.

The release on January 4th, 2017 of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology represents the first time in 30 years that the Federal government has produced a comprehensive summary of the roles and responsibilities of the three principal regulatory agencies with respect to regulating biotechnology products.

Early in 2016, EPA, FDA, and USDA commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products. The study, which is ongoing, will identify (1) major advances and potential new types of biotechnology products over the next five to ten years, (2) potential future products that might pose a different type of risk relative to existing products and organisms, (3) areas in which the risks or lack of risk relating to biotechnology are well understood, and (4) the scientific capabilities, tools, and expertise that may be useful to the regulatory agencies as they oversee potential future products of biotechnology.

…The findings by the NAS report on future biotechnology products, along with the comments submitted in response to the proposed Update to the Coordinated Framework and information gathered during the three public engagement sessions that EPA, FDA, and USDA hosted in 2016, will be considered by these agencies in order to inform ongoing and future agency activities.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System