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Animal Biotechnology Products Development & Approval Process

Aug. 30, 2022

Development & Approval Process

Animal Drugs, Animal Biotechnology Products, and Animal Food Additives

Animal Biotechnology Products

FDA encourages the development and research of animal biotechnology products, such as intentional genomic alterations (IGAs) in animals and animal cells, tissues, and cell- and tissue-based products (ACTPs). By intentionally altering an animal’s DNA, desirable traits can be introduced into its genetic make-up. This process includes, but is not necessarily limited to, genome editing technologies and genetic engineering. ACTPs are products that contain cellular material—such as living cells, serum, or other products derived from cells or tissues—for use in animals with the hope of repairing diseased or damaged tissues or organs. 


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Source from FDA


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