Update to the Coordinated Framework for the Regulation of Biotechnology
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. 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 summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.