The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is posting an informational, pre-recorded animal biotechnology webinar. This webinar is intended to help developers understand what data CVM expects them to submit for their product. To accomplish this, CVM has prepared hypothetical case studies outlining the risk questions CVM poses for specific types of products. The webinar describes the hypothetical products and provides information on CVM’s oversight process, which entails a science- and risk-based approach with various levels of review (ranging from no review of data, to review of data addressing relevant risk factors, and to full review) based on a product’s risk; as well as the data expectations for submissions.
- Case study 1: Intentional Genomic Alteration (IGA) in rainbow trout intended for food use
- Case study 2: IGA in pigs as animal model of disease
To view the webinar, please go to https://collaboration.fda.gov/pwj97z4cknho/.
CVM is accepting stakeholder questions which CVM will address through the publication of additional outreach materials that can be used to enhance the predictability, transparency, and efficiency of CVM’s animal biotechnology product review process and the Veterinary Innovation Program (VIP). After viewing the webinar, stakeholders can provide feedback and questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov.