Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Development & Approval Process

Biotechnology Products at CVM: Animals and Animal Food

                        
                VIP: Veterinary Innovation Program


                Intentional Genomic Alterations (IGAs) in Animals
          Cell and Tissue Products for Animals
          Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center Home
          Animal & Veterinary
          Development & Approval Process
          Biotechnology Products at CVM: Animals and Animal FoodDevelopment & Approval Process Biotechnology Products at CVM: Animals and Animal Food
  	
        Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintAnimal 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

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

FDA’s Regulation of Plant and Animal Biotechnology Products
	The Coordinated Framework for Regulation of Biotechnology
	Federal Register Notice: Office of Science and Technology Policy. Coordinated Framework for Regulation of Biotechnology; Announcement of Policy and Notice for Public Comment. June 26, 1986
	Federal Register Notice: Science and Technology Policy Office. Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology. Sept 22, 2016
	The Unified Website for Biotechnology Regulation
	FDA’s Plant and Animal Biotechnology Innovation Action Plan
	Agricultural Biotechnology: Feed Your Mind
	Veterinary Innovation Program
	Development & Approval Process
	Animal Biotechnology Information Rounds
	FDA-Track: CVM - Emerging TechnologiesGuidances for Industry (GFIs)

Draft CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals
	CVM GFI #218 Cell-Based Products for Animal Use
	CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products
	CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based ProductsPlant biotechnology for animal food

FDA has provided the following additional resources:

Food from New Plant Varieties
	Understanding New Plant Varieties
	Voluntary Labeling of Foods Derived from Genetically Engineered Plants

                                                                                  Content current as of:
      10/27/2023Biotechnology Products at CVM: Animals and Animal Food                
                          

                        VIP: Veterinary Innovation Program


                        Intentional Genomic Alterations (IGAs) in Animals
          Cell and Tissue Products for Animals
          Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center
 Subscribe to Animal Biotechnology Updates
                        Get email updates delivered to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop