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:

                Guidance for Industry

Guidance for Industry

                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
          Withdrawn/Replaced Guidances Home
          Animal & Veterinary
          Guidance & Regulations
          Guidance for Industry
          Post-Approval Reporting GuidancesGuidance for Industry Post-Approval Reporting Guidances
  
  	
    Share
    Post
    Linkedin

    Email
    PrintAdverse Event Reporting

CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)
	CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
	CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
	CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
	CVM GFI #214 (VICH GL35) - Electronic Standards for Transfer of DataOther Post-Approval Reporting

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
	Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act

                                                                                  Content current as of:
      04/14/2023Guidance for Industry

          
                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
          Withdrawn/Replaced Guidances
 
 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