Source: dvm 360
The FDA announced updates to its oversight of intentional genomic alterations (IGAs) in animals, aiming to modernize and streamline the evaluation process for innovative animal products. This includes establishing a memorandum of understanding (MOU) with the USDA to clarify regulatory roles. IGAs involve modern molecular technologies for DNA sequence changes in animals, serving various purposes like improving human health, enhancing animal well-being, and boosting food production.
The FDA released guidance documents, GFI #187A and a revised draft of GFI #187B, to clarify regulatory requirements and approval processes for IGAs. GFI #187A outlines a risk-based approach categorizing products into three risk levels, while GFI #187B provides technical guidance for products requiring approval. The FDA seeks public comments on GFI #187B. The MOU between FDA and USDA aims to facilitate information sharing and coordinated regulatory efforts without introducing new regulations. The FDA encourages early engagement with developers and participation in the Veterinary Innovation Program to support the regulatory process.
Read the full story HERE: https://www.dvm360.com/view/advancing-regulations-for-intentional-genomic-alterations-in-animals