The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has released pre-recorded informational webinars titled “Industry Guidance #187A: Heritable Intentional Genomic Modifications (IGAs) in Animals: A Risk-Based Approach” and “Industry Guidance #187B: Heritable Intentional Genomic Modifications (IGAs) in Animals: Approval Process.”
CVM recently issued two guidance documents on FDA requirements and recommendations for heritable intentional genomic modifications (IGAs) in animals. Draft Guidance for Industry (GFI) #187A describes FDA’s risk-based regulatory approach to oversight of heritable IGAs in animals. Draft GFI #187B provides technical guidance for IGAs in animals going through the approval process. The webinar will provide historical background to the guidance and provide more details on what it covers.
Part 1: Guidance for Industry #187A: Heritable Intentional Genomic Modifications (IGA) in Animals: A Risk-Based Approach
Part 2: Guidance for Industry #187B: Intentional Genome Modifications (IGA) in Animals: Approval Process
The webinar will remain available on our website as a resource for animal IGA developers. Interested parties may submit questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov or email AskCVM-Biotech@fda.hhs.gov for specific product-related questions.
CVM is also accepting public comments on draft GFI #187B. Please submit comments by July 31, 2024 for consideration before we draft a final guidance document; however, comments on both guidance documents are welcome at any time. To submit comments electronically to the draft GFI #187B docket, visit https://www.regulations.gov and enter FDA-2019-D-2648 in the search box.
Content is current:
June 28, 2024
