FDA Clarifies Approach to Genomic Alterations in Animals

FDA, USDA Establish Memorandum of Understanding to Clarify Roles and Responsibilities for Regulation of Intentional Genomic Alterations in Animals

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.