FDA Announces Plant and Animal Biotechnology Innovation Action Plan

Today, the U.S. Food and Drug Administration announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission. The overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation.The FDA’s Center for Veterinary Medicine (CVM) is launching a pilot of this program today to offer intensive technical and programmatic assistance to developers of certain innovative veterinary products, including animal biotechnology products. VIP includes a set of tools to guide sponsors through the regulatory process, options to develop alternative strategies for generating necessary evidence, pre-submission reviews of data packages, and cross-disciplinary and coordinated FDA review.CVM, along with representatives from FDA’s Center for Biologics Evaluation and Research (CBER), will host a live-cast webinar on Dec. 3, 2018 to discuss FDA’s flexible, risk-based regulatory approach and current scientific evidence and regulatory science questions that are important for the agency’s decision-making for genome editing in animals.