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  1. Development & Approval Process

Biotechnology Products at CVM: Animals and Animal Food

Animal Biotechnology

CVM is committed to using a science- and risk-based regulatory framework to further the advancement of emerging technologies for the development of safe and effective products, while ensuring consumer confidence. CVM regulates the following types of animal biotechnology products:

  • Intentional genomic alterations (IGAs) in animals;
  • Animal cells, tissues, and cell- and tissue-based products (ACTPs); and
  • Animal food derived from plants produced with biotechnology.

CVM encourages and supports the development and research of innovative animal products, such as IGAs in animals and ACTPs. To facilitate advancements in development of innovative animal products, CVM instituted the Veterinary Innovation Program (VIP), which provides greater certainty in the regulatory process, encourages development and research, and supports an efficient and predictable pathway to approval for ACTPs and IGAs in animals. Additionally, to assist developers of animal biotechnology products in understanding the regulatory process, CVM offers the Animal Biotechnology Products Resource Center.

IGAs in Animals

Intentionally altering genomic DNA is a process that includes, but is not necessarily limited to, the use of molecular technologies such as genome editing (e.g., CRISPR) or use of recombinant DNA constructs to introduce desirable traits into organisms.


ACTPs are articles containing, consisting of, or derived from cells or tissues that are intended for implantation, transplantation, infusion, transfer, or other means of administration to an animal recipient. 

Related Resources

Guidances for Industry (GFIs)

Plant biotechnology for animal food

FDA has provided the following additional resources:


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