Heritable Intentional Genomic Alterations in Animals: The Approval Process; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This draft guidance is intended to clarify FDA's requirements and recommendations for developers of intentional genomic alterations (IGA) in animals. The draft guidance is being issued as one of two companion documents. "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the FDA approval process applies to heritable IGAs in animals. FDA is issuing GFI #187B as a draft guidance to solicit comments that will enable the Agency to update, and make as efficient as possible, the approval process for IGAs in animals. In addition, FDA requests comments on questions that it intends to address in the final version of this guidance document. The companion final guidance, GFI #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk- Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals. This means that, for people or companies developing certain types of IGAs in animals, FDA may not expect them to submit an application or get approval before marketing their product.