FDA Animal Biotechnology Webinars on GFI #187A and #187B: Heritable Intentional Genomic Alterations in Animals

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is posting informational, pre-recorded webinars entitled “Guidance for Industry #187A: Heritable Intentional Genomic Alterations (IGAs) in Animals: Risk-Based Approach” and “Guidance for Industry #187B: Heritable Intentional Genomic Alterations (IGAs) in Animals: The Approval Process”. 

In 2024, CVM issued two guidance documents on FDA’s requirements and recommendations with respect to heritable intentional genomic alterations (IGAs) in animals. Guidance for Industry (GFI) #187A describes FDA’s risk-based regulatory approach to the oversight of heritable IGAs in animals. GFI #187B provides technical guidance for those IGAs in animals that go through the approval process. The webinars provide historical background on the guidances and walk through the details of what they cover. 

Part 1: Guidance for Industry #187A: Heritable Intentional Genomic Alterations (IGAs) in Animals: Risk-Based Approach

Part 2: Guidance for Industry #187B: Heritable Intentional Genomic Alterations (IGAs) in Animals: The Approval Process

The webinars will remain available on the website as a resource for developers of IGAs in animals. Note that Part 2 was recorded prior to finalization of GFI #187B but the information contained in the webinar remains consistent with the final GFI.

If you have questions about an animal biotechnology process or product, please contact the agency at AskCVM-Biotech@fda.hhs.gov. For information on other product types or for all other general inquiries, contact AskCVM@fda.hhs.gov.