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  6. FDA Animal Biotechnology Webinars on GFI #187A and #187B: Heritable Intentional Genomic Alterations in Animals
  1. Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center

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”. 

CVM recently 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. Draft 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 webinar will remain available on the website as a resource for developers of IGAs in animals. Stakeholders can submit any questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov, and if you would like to contact us with questions about a specific product, please email AskCVM-Biotech@fda.hhs.gov

CVM is also accepting public comments on draft GFI #187B. Please submit comments by July 31, 2024, to ensure that we are able to consider them before drafting the final guidance document; however, comments on both guidance documents are welcome at any time. To submit comments electronically to the docket for draft GFI #187B, visit https://www.regulations.gov and type FDA-2019-D-2648 in the search box.

 
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