Regulatory Pathways Emerge For Gene-Edited Products

There has long been uncertainty about when and how U.S. regulators would respond to emerging genetic technologies such as gene editing (e.g., CRISPR, TALENs). This uncertainty has posed issues for a range of innovators who are quickly adopting these techniques as a more targeted, efficient tool to achieve desired products. In a series of publications, the agencies responsible for the Coordinated Framework for Biotechnology, namely USDA, FDA and EPA, have finally provided some insight into how regulators might approach these products and they invite comments from stakeholders on how best to proceed. Each agency proposal has the potential to significantly shape the integration of emerging genetic technologies into product development. It is important for stakeholders to understand these developments and engage with regulators to shape policy in a rapidly evolving area.