The 2017 Update to the Coordinated Framework for the Regulation of Biotechnology was released by the EPA, FDA, and USDA on January 4, 2017. The so-called Coordinated Framework is accompanied by the National Strategy for Modernizing the Regulatory System for Biotechnology Products.
This significant step was taken to provide a comprehensive summary of the roles and responsibilities of the three primary regulatory agencies for biotechnology products. Increasing public confidence and awareness around biotechnology product regulation, and reducing the challenges for small to mid-size companies trying to navigate the regulations are two of the primary goals of this focus. Having clarity around which agency is responsible and has authority, and how this rolls out during regulatory assessment is important.
Take a few minutes to review the updated Coordinated Framework.