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:

                CVM Updates

CVM Updates Home
          Animal & Veterinary
          News & Events
          CVM Updates
          FDA Announces Project to Provide Key Tool for Animal Biotechnology DevelopersCVM Updates FDA Announces Project to Provide Key Tool for Animal Biotechnology Developers
  
  	
    Share
    Post
    Linkedin

    Email
    PrintMay 10, 2023

Today the U.S. Food and Drug Administration is announcing a joint project with the National Institute of Standards and Technology (NIST) that aims to provide an important new resource for researchers and companies creating innovative animal biotechnology products by using genome editing to alter the genome of animals. This project is part of the FDA’s efforts to further development of safe, beneficial biotechnology products.

The FDA is committed to facilitating advancements in development of innovative animal products by providing greater certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to market for Intentional Genomic Alterations (IGAs) in animals. Genome-editing technology, like CRISPR, has revolutionized the ability to make targeted changes to an animal’s genome, offering exciting promise for the creation of animal biotechnology products that address public and animal health concerns.

However, both developers and regulators recognize that with genome editing there is a possibility of unintended alterations that might impact the health of the animal or the safety of meat, milk or eggs from the animal. Developers in the field have expressed the need for certain tools that can help them produce safe products: standardized measurements for characterizing both intended and unintended alterations in animals whose genomes have been altered using genome editing and access to suitable comparator or reference materials.

To address these needs, the FDA has funded and is working collaboratively on a project, headed by NIST, that will generate these needed resources. Specifically, the project aims to generate standardized measurements for characterizing IGAs in cattle and swine that are developed using genome editing. These resources support the molecular characterization of genome-edited animals, which can apply to animals for different uses (i.e., sources of therapeutic products such as organs for transplantation into humans) and animals for agriculture or human food use. In addition to helping developers, these methods and materials will also improve regulators' confidence in developers' evaluations, potentially reducing time to the marketplace.

This information will be complementary to the FDA’s Veterinary Innovation Program, a program the FDA launched in 2018, which can increase the predictability of the regulatory pathway, facilitate a lower number of review cycles, and reduce the overall time to approval. Continuing interactions and collaboration with the FDA throughout the approval process maximizes the ability to address potential challenges in product development, leverage data from multiple sources, minimize the number of studies conducted to support approval, enhance communication in the review process, and maintain an understanding of current scientific and regulatory advancements.

The FDA has decades of experience facilitating the development of complex and innovative technologies, including animal biotechnology, and has emerged as a trusted global regulator. The agency is committed to working efficiently and collaboratively with developers to bring new and beneficial animal biotechnology products to consumers, while also ensuring their safety and effectiveness. This project will provide developers of IGAs in animals with a roadmap, summarizing the data, protocols, potential reference materials, and measurements NIST has generated, which can be used to determine and validate methods and assays intended to characterize IGAs in animals. More information about the project will be posted on the FDA’s website later this year.

For more information

Intentional Genomic Alterations (IGAs) in Animals
	Q&A on FDA Regulation of Intentional Genomic Alterations in Animals
	Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center
	VIP: Veterinary Innovation Program
	NIST/FDA CVM Evaluation of Assays and Control Materials for Characterizing Genome-Edited Animal Biotechnology Products**Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.**

                                                                                  Content current as of:
      05/10/2023CVM Updates
 
 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