FDA is issuing this draft revised Guidance for Industry to clarify its approach to the regulation of intentionally altered genomic DNA in animals. This guidance addresses animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal. This guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration.

This draft revised guidance has been issued for public comment and has not yet been finalized. Until finalized, final GFI #187, “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs,” updated most recently in 2015, remains in effect.

Questions?