September 28, 2020

As part of its ongoing commitment to support innovation in animal biotechnology and advance public health, the FDA’s Center for Veterinary Medicine (CVM) is announcing a stakeholder outreach initiative for developers of animal biotechnology, including an informational, pre-recorded webinar and ongoing stakeholder engagement regarding the FDA’s oversight of products of animal biotechnology. 

The goals of this initiative are to provide transparency between CVM and its stakeholders and to collect feedback that CVM can use to enhance the predictability, transparency, and efficiency of its animal biotechnology product review process and the Veterinary Innovation Program (VIP).

Today CVM is posting a pre-recorded, informational webinar on its website intended to help developers understand data expectations for marketing of a new animal biotechnology product. In the webinar, CVM presents hypothetical case studies outlining the risk questions CVM poses for specific types of products.  CVM uses a science- and risk-based approach to the oversight of food and animal products of biotechnology 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. 

CVM is collecting stakeholder comments and questions on the content presented in the webinar. CVM intends to address the comments and questions received through the publication of additional outreach materials or meetings.

For more information:

• FDA CVM Animal Biotechnology Webinar 
• Animals with Intentional Genomic Alterations 
• Industry Q&A
• Intentional Genomic Alterations in Animals: Enforcement Discretion