FDA Regulation of Intentionally Altered Genomic DNA in Animals (Draft Guidance)

The Policy

What it does

Clarifies FDA’s requirements and recommendations for producers and developers of genetically engineered animals and their products, and expands the scope of the guidance to include animals intentionally altered through use of genome editing techniques.

Synopsis

The Food and Drug Administration's (FDA) draft guidance for industry (GFI) #187, entitled ‘‘Regulation of Intentionally Altered Genomic DNA in Animals, revises GFI #187 entitled ‘‘Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs’’ (current GFI #187). Current GFI #187 clarifies FDA’s requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. It describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act apply with respect to GE animals. This draft revision of current GFI #187 expands the scope of the guidance to include animals intentionally altered through use of genome editing techniques. The draft revised GFI #187 now applies to ‘‘those animals whose genomes have been intentionally altered using modern molecular technologies.’’

Context