The Food and Drug Administration (FDA) has announced the availability of a draft guidance titled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease."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 The public can submit comments about this draft guidance electronically or in writing until March 10, 2025.
Simple Explanation
The FDA is sharing a new idea about how they might not need to check every time scientists change the genes of farm animals like pigs and rabbits to study diseases, but only if they are sure it’s safe. People can tell the FDA what they think about this until March 2025.