WASHINGTON: The White House has released the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The “2017 Update” provides a comprehensive summary of the roles and responsibilities of the three principal regulatory agencies, Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and United States Department of Agriculture (USDA) with respect to regulating biotechnology products.
Together with the National Strategy for Modernising the Regulatory System for Biotechnology Products which was published in September 2016, the 2017 Update offers a complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.
In order to help product developers and the public understand what the regulatory pathway for products might look like, this 2017 Update to the Coordinated Framework presents information about agency roles and responsibilities in several forms, including: graphics that illustrate agency-specific overviews of regulatory roles; case studies that demonstrate how a product developer might navigate the regulatory framework; and a comprehensive table that summarises the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
