RT journal article T1 Genetically Modified Animal-Derived Products: From Regulations to Applications A1 Fajardo Quiñones, Carlos A1 Macedo, Marta A1 Buha, Tonka A1 De Donato, Marcos A1 Costas, Benjamín A1 Mancera Romero, Juan Miguel A2 Biología K1 CRISPR K1 FDA K1 gene-editing K1 genetic engineering K1 GMO K1 intentional genomic alterations AB Biotechnological advances applied to the generation of genetically modified (GM) animals have shown the potential to develop innovative solutions for different challenges in key areas such as agriculture and human medicine. Despite its enormous potential, the deployment of genetic modification in animals, and its subsequent commercialization, does not meet the same public acceptance as GM plant-derived products, which are currently widely adopted around the world. In this review, we highlight the main examples of GM and gene-edited animal-derived products already approved by the FDA and discuss the regulatory context inherent to such processes, including the risk-based assessment analysis based on a case-by-case evaluation. Moreover, cases of GM animals already approved by other jurisdictions around the world are also discussed. PB Multidisciplinary Digital Publishing Institute (MDPI) SN 2076-2615 YR 2025 FD 2025 LK http://hdl.handle.net/10498/38720 UL http://hdl.handle.net/10498/38720 LA eng DS Repositorio Institucional de la Universidad de Cádiz RD 08-nov-2026