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  6. FDA CVM Animal Biotechnology Webinar for Developers
  1. Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center

FDA CVM Animal Biotechnology Webinar for Developers

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/. 

After viewing the webinar, stakeholders can provide feedback and questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov.

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. 

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