Search Results for keywords:"Heritable Intentional Genomic Alterations"

The Food and Drug Administration (FDA) has announced the availability of a draft guidance titled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This guidance focuses on policy for genomic alterations in animals like swine and rabbits, which are used as models for human or animal diseases in biomedical research. The FDA may not require developers of these altered animals to submit an application for approval if the risk factors have been reviewed and are determined to be manageable. The public can submit comments about this draft guidance electronically or in writing until March 10, 2025.

The Food and Drug Administration (FDA) has released a final guidance document titled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This guidance outlines the FDA's requirements and recommendations for developers working on genetic changes in animals that can be passed down to future generations. The document explains how the FDA evaluates and approves these genetic alterations, addressing concerns such as animal health and food safety. The announcement also notes that the public can submit comments on this guidance through various methods, as described in the Federal Register notice.