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 Meetings, Conferences and Workshops

FDA Meetings, Conferences and Workshops

                        FDA Meetings, Conferences, and Workshops: Past Events
          FDA Annual Reports on Conferences


                        Public Calendar - Meetings With FDA Officials Home
          News & Events
          FDA Meetings, Conferences and Workshops
          Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop - 03/30/2023FDA Meetings, Conferences and Workshops Workshop
    Event Title
              Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop


                  March 30, 2023

  Scheduled

    
  Share
    Post
    Linkedin

    Email
    PrintOn This Page
      Meeting Information
                Event MaterialsDate:
          
  


     
           

March 30, 2023   

 
 
        
                                      Time: 
                                      
8:30 AM
    - 4:15 PM
ET
                
  Organized By: 
      Organizer
          Blood, Vaccines and Other Biologics

 

  BACKGROUND:

Immune Globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases.  The purpose of the workshop is to gain insight and to identify measures to prevent   hypersensitivity reactions associated with specific lots of Immune Globulins (IG).   The symptoms of these reactions typically include urticaria, hives, pruritis, and orofacial swelling.   Occasionally, these skin-related symptoms are accompanied by chest pain or shortness of breath.  In some patients, anaphylaxis-like events have been reported.

Although hypersensitivity is listed as a possible reaction to IG products, FDA and manufacturers have observed excessive numbers of hypersensitivity reactions for specific lots of IG.  Such lots occur episodically and unpredictably.  This phenomenon has led to voluntary market withdrawals of IG product lots and adversely affected a proportion of patient recipients.  Resulting withdrawals of product lots and quarantine of manufacturing intermediates can adversely affect IG supply. The cause of these reactions is unknown.

TOPICS FOR DISCUSSION:

Clinical presentations and epidemiology of patients with hypersensitivity reactions to specific lots of IG
	Pathogenesis of Type I hypersensitivity reactions
	Manufacturer investigations – including plasma donor factors, potential recipient risk factors, and manufacturing and laboratory investigations of implicated plasma units and IG lotsAGENDA:

Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation Agenda

OBJECTIVES:

The overarching workshop goals are to enhance patient safety and preserve product availability.  The objectives of the workshop are to share knowledge that will contribute to prevention of lot-specific hypersensitivity reactions, and to seek opinions from scientific experts on:

The most likely root cause(s) of reactions
	Potential recipient risk factors
	Development of pragmatic *in vitro* methods to identify plasma units or products that mediate lot-specific hypersensitivityRECORDING:

**Topic:** Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation - Recordings

LOCATION:

This is a virtual webcast only event.  The link for viewing/participation will be provided within your Eventbrite confirmation upon registration.

REGISTRATION INFORMATION:

To register for this public workshop, please visit the following website: https://www.eventbrite.com/e/immune-globulin-hypersensitivity-reactions-root-causes-and-mitigation-tickets-558320711277.  Registration is free and based on space availability.  If you need special accommodations due to a disability, please contact Loni Warren Henderson or Sherri Revell no later than March 23, 2023 (subject line:  IG Hypersensitivity Workshop) at the contact information provided below.

FOR FURTHER INFORMATION CONTACT:

Loni Warren Henderson or Sherri Revell, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver Spring, MD 20993, or 240-402-8180, or CBERPublicEvents@fda.hhs.gov (subject line: IG Hypersensitivity Workshop)





Event Materials

  Title
            File Type/SizeTranscript - Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation
              pdf               (1.82 MB)

                                                                                  Content current as of:
      08/02/2023
         
                   
Regulated Product(s)
		 BiologicsMore Meetings,
      Conferences, and
      Workshops
        
        FDA Meetings, Conferences and Workshops

          
                        FDA Meetings, Conferences, and Workshops: Past Events
          FDA Annual Reports on Conferences


                        Public Calendar - Meetings With FDA Officials
 
 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