Article History
Received: 9 January 2019
Accepted: 21 February 2019
First Online: 20 March 2019
Competing interests
: The authors declare no competing Interests, but all are actively involved in a research capacity with food animal gene editing research at their respective U.S. universities. As such their research animals with intentional genomic alterations all fall under the proposed regulatory approach outlined in FDA’s draft “Guidance for Industry #187” entitled, “Regulation of Intentionally Altered Genomic DNA in Animals”. Further K.D.W is an inventor on University of Missouri IP (PRRS-resistant knockout pig<sup>57</sup>) licensed to Genus that is being taken through the FDA’s regulatory review process.