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On April 25, 2019, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM), with participation from the agency’s Center for Biologics Evaluation and Research (CBER), held a public webinar about genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits. This webinar was rescheduled from the original date of December 3, 2018.

The webinar focused primarily on the current scientific evidence, promising uses of this technology in animals, and the potential risks. The webinar also provided information about CVM’s flexible, risk-based approach to the regulation of intentional genomic alterations (IGAs) in animals, including alterations made with genome editing, and how, if needed, to navigate FDA approval requirements for IGAs that are products of this technology. It also addressed common questions associated with FDA oversight. The final portion of the webinar was dedicated to answering stakeholder-submitted questions. This webinar did not cover genome editing of plants for use in human and/or animal food.

Webinar Recording

The webinar can be viewed at https://collaboration.fda.gov/piqkyfroaabr/.

Additional Information

• FDA’s Regulation of Plant and Animal Biotechnology Products
• FDA’s Plant and Animal Biotechnology Innovation Action Plan
• FDA Announces Plant and Animal Biotechnology Innovation Action Plan
• Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation

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