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FDA wants to regulate gene edited animals

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. 1,2,3 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. More recently, new technologies have emerged that are intended to alter the genomes of various organisms, including animals. Some of these include the use of “nucleases” or “genome editing technologies” including engineered nuclease/nucleotide complexes such as zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALENs), and the clustered regulatory interspersed short palindromic repeats (CRISPR) associated systems. 8 These nucleases are intended to introduce alterations at specific sites in the genome, rather than the more random changes associated with rDNA technology. The process of producing these targeted DNA sequence alterations is often referred to as “genome editing.” We anticipate that other technologies intended to alter genomic DNA will arise over time.

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