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:

                About Science & Research at FDA

About Science & Research at FDA

                        Emerging Sciences
          Public Access to Results of FDA-Funded Scientific Research
          Scientific Integrity at FDA
          FDA Sexual Harassment Policy Concerning Extramural Research
          Medical Product Development Tools at FDA
          Modeling & Simulation at FDA
          FDA's Predictive Toxicology Roadmap


                        Advancing Alternative Methods at FDA
          FDA Grand Rounds
          The FDA Science Forum Home
          Science & Research
          About Science & Research at FDA
          FDA's Predictive Toxicology RoadmapAbout Science & Research at FDA FDA's Predictive Toxicology Roadmap
  
  	
    Share
    Post
    Linkedin

    Email
    Print**FDA's Predictive Toxicology Roadmap**



**FDA’s Predictive Toxicology Roadmap** was published in December 2017 by the Food and Drug Administration’s (FDA’s) Toxicology Working Group. It describes FDA’s current thought on viable ways to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into FDA regulatory review.

This six-part framework outlines Agency priorities and engagement in predictive toxicology, emphasizes the importance of the context of use, and identifies toxicology issues related to FDA-regulated products. FDA’s Predictive Toxicology Roadmap also identifies the toxicology areas that could benefit from improved predictivity as well as promising new technologies that could potentially meet these needs and support animal 3Rs (Replacement, Reduction, and Refinement).

Advancing Alternative Methods at FDA

As part of efforts to support its Toxicology Working Group in advancing the goals of FDA's Predictive Toxicology Roadmap, the agency formed the Alternative Methods Working Group in 2020.  A dedicated web section **Advancing Alternative Methods** **at FDA** serves as a platform for the latest FDA activities in this area.  Among them are a **webinar series** inviting developers to showcase their cutting-edge technologies to FDA scientists and **publications on alternative methods** co-authored by FDA scientists.


Public Events

**Public Workshop**September 18, 2019: Implementing FDA's Predictive Toxicology Roadmap: An Update of FDA's Activities
	**Public Hearing**September 12, 2018: FDA's Predictive Toxicology RoadmapReports

2018 Annual ReportResources For You

FDA Launches Predictive Toxicology Roadmap to Enable Advances in Toxicity Testing (Archived)
	Advancing Alternative Methods at FDA
	FDA Webinar Series on Alternative Methods

                                                                                  Content current as of:
      09/25/2020
              
              
Topic(s)
			  Research
				    				       				    				       Public AwarenessAbout Science & Research at FDA

          
                        Emerging Sciences
          Public Access to Results of FDA-Funded Scientific Research
          Scientific Integrity at FDA
          FDA Sexual Harassment Policy Concerning Extramural Research
          Medical Product Development Tools at FDA
          Modeling & Simulation
          FDA's Predictive Toxicology Roadmap


                        Advancing Alternative Methods at FDA
          FDA Grand Rounds
          The FDA Science Forum
 
 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