Source: Food & Drug Administration (FDA) news release
Today, the U.S. Food and Drug Administration took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s commitment to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictability and efficiency. In addition, the agency established a memorandum of understanding (MOU) with the U.S. Department of Agriculture (USDA) to clarify roles and responsibilities for regulation of IGAs in animals.
“We recognize that innovations in animal biotechnology offer tremendous opportunities for advancing human and animal health, and that we as an agency need to keep our regulatory approach current with the evolution of the science,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine. “These updated guidance documents demonstrate our commitment to facilitating innovation while ensuring product safety.
“These technologies hold great promise for many uses and public and animal health benefits, such as animal disease resistance, control of zoonotic disease transmission, improved animal husbandry, and increased food production and quality.”
IGAs in animals can be made using modern molecular technologies, which may include random or targeted DNA sequence changes, including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal. IGAs in animals have many different intended uses, including applications in human health (e.g., reduced allergenicity; “biopharm” animals that produce substances, generally in their milk or eggs, for use in the production of human therapeutics; animals used to model human disease), in improved animal health, well-being, and husbandry practices (e.g., disease resistance, heat tolerance), and in enhanced production and food quality (e.g., faster growth, feed efficiency, nutritional benefits).
The two documents released today, final Guidance for Industry (GFI) #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,” and draft revised GFI #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process,” are intended to help industry understand the existing statutory and regulatory requirements as they apply to IGAs in animals and to inform the public about the FDA’s process for regulating them.
