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:

                FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Agency-wide Program Performance

                        FDA-TRACK: What's New
          FDA-TRACK: User Fee Performance
          About FDA-TRACK
          FDA-TRACK: Site Map Home
          About FDA
          Transparency
          FDA-TRACK: Agency-wide Program Performance
          FDA-TRACK: Animal Generic Drug User Fee Act (AGDUFA) PerformanceFDA-TRACK: Agency-wide Program Performance FDA-TRACK: Animal Generic Drug User Fee Act (AGDUFA) Performance
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintSubscribe to FDA-TRACK Updates


Menu

Animal Generic Drug Applications and Supplements

• Current Performance

• Historical Performance


Relevant Links:

• AGDUFA III Performance Goals and Procedures
	• AGDUFA Performance Reports
	• AGDUFA Report Information
	• AGDUFA Meetings
	• FDA-TRACK: CVM Dashboards


On August 14, 2018, the second reauthorization of the Animal Generic Drug User Fee Act (AGDUFA), referred to as AGDUFA III, was signed into law. ADUFA III amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing AGDUFA for an additional five years (FY 2019 through FY 2023). AGDUFA provides FDA with resources to enhance the performance and predictability of the generic new animal drug review process resulting in more readily available safe and effective new products.


The Animal Generic Drug User Fee Performance Dashboards (AGDUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated AGDUFA Performance Report to Congress for the Animal Generic Drug User Fee Act (the Report). The AGDUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The AGDUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2023. The AGDUFA Dashboards present final performance in meeting AGDUFA goals for FY 2022 and preliminary performance for FY 2023. Final AGDUFA performance data for FY 2023 will be presented in the FY 2024 AGDUFA Report and referenced in updated versions of the AGDUFA Dashboards.

Animal Generic Drug Applications and Supplements

The Animal Generic Drug Applications and Supplements Dashboard displays current performance relating to the review of:

Original Abbreviated New Animal Drug Applications (ANADAs) and Reactivations
	Administrative ANADAs
	Manufacturing Supplemental ANADAs and Reactivations
	Generic Investigational New Animal Drug (JINAD) Study Submissions
	JINAD Protocol Submissions

                                                                                  Content current as of:
      12/14/2023FDA-TRACK: Agency-wide Program Performance

          
                        FDA-TRACK: What's New
          FDA-TRACK: User Fee Performance
          About FDA-TRACK
          FDA-TRACK: Site Map
 Sign up to receive FDA-TRACK updates
                          Get regular FDA email updates delivered on this topic 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