The U.S. FDA, Environmental Protection Agency, and Department of Agriculture have responded to President Biden’s call by unveiling a comprehensive plan to overhaul biotech regulations. Prompted by Executive Order 14081, issued in September 2022, the plan aims to modernize regulations surrounding the development and manufacture of biotech products, from industrial goods to CRISPR technologies. Stakeholder feedback, including input from industry groups and public commentary, has shaped the plan, highlighting the need for clarity, synchronization, and updates to existing regulations.
Future policy initiatives outlined in the plan include proposed revisions to regulations on post-approval chemistry, manufacturing, and controls (CMC) changes, as well as the establishment of a platform technology designation program for expedited development of gene editing products. Additionally, efforts are underway to streamline regulatory processes for gene editing therapies, with a focus on reducing burdensome requirements while ensuring safety and efficacy standards. The plan signals a concerted effort by U.S. agencies to adapt regulatory frameworks to advancements in biotechnology, fostering innovation and addressing emerging challenges in the field.
