The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is announcing an Animal Biotechnology Stakeholder Outreach Session that will be open to the public and will take place virtually on Wednesday, July 28 from 3:40 – 4:45 PM ET (2:40 - 3:45p.m. CST) via Zoom. The session is open to all stakeholders at no cost and will take place in conjunction with the Genome Writer’s Guild 2021 conference.
At the session, CVM will collect feedback from stakeholders in order to enhance the predictability, transparency, and efficiency of the review process for intentional genomic alterations (IGAs) in animals. Specifically, the Veterinary Innovation Program is available to most developers of IGAs in animals and is aimed at facilitating advancements in the development of innovative animal products by providing greater certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to approval.
For researchers, a genomically-altered animal is not a drug. Rather, the agency is regulating IGAs in animals under the new animal drug provisions of the Food, Drug & Cosmetics Act. This means that FDA determines that the IGA is safe for the animal, safe to anyone that eats food derived from the animal, and that it is “effective,” i.e. it does what the developer claims it will do.
At the session, CVM will elaborate on its science- and risk-based approach for IGAs and will provide a brief overview of the agency’s risk analysis and review process. The session will conclude with breakout group listening/feedback sessions where stakeholders are encouraged to provide their input.