WH Reviewing Two FDA Genomic Alterations Guidances

The White House is reviewing two FDA guidances that are expected to lay out how the agency will regulate genomic alterations of animals and that one source suspects will describe how the agency will exercise regulatory flexibility for intentional genomic alterations. FDA sent the guidances -- one draft and one final -- to the White House budget office on April 27, two months after making its first low-risk determination for animals that have undergone a genomic alteration. The first document...