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:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Withdrawn Guidances (Biologics)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Withdrawn Guidances (Biologics)
					
		
		January 2017


	 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintIssued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research




Title
			Date Issued
			(year-month-day)
			Date Withdrawn
			(year-month-day)Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency - Final
			2022-01-21
			2023-01-17Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components
			2018-07-08
			2021-05-12Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances - Final
			1980-06-01
			2020-07-10Guideline for the Uniform Labeling of Blood and Blood Components - Final
			1985-08-01
			2020-07-10Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1 - Final
			1989-08-01
			2020-07-10Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors) - Final
			1989-10-01
			2020-07-10Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin) - Final
			1992-01-01
			2020-07-10Recommended Methods for Blood Grouping Reagents Evaluation - Draft
			1992-03-01
			2020-07-10Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin - Draft
			1992-03-01
			2020-07-10Guideline for Quality Assurance in Blood Establishments - Final
			1995-07-11
			2020-07-10Screening and Testing of Donors of Human Tissue Intended for Transplantation - Final
			1997-07-01
			2020-07-10Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products - Final
			1998-01-08
			2020-07-10Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing - Final
			1998-06-11
			2020-07-10Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans - Final
			1999-04-06
			2020-07-10Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens - Final
			2000-06-01
			2020-07-10Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens - Final
			2000-06-01
			2020-07-10Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - Final
			2000-11-20
			2020-07-10Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts - Final
			2000-11-20
			2020-07-10Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS - Final
			2003-09-16
			2020-07-10Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - Final
			2004-01-22
			2020-07-10Development of Preventive HIV Vaccines for Use in Pediatric Populations - Final
			2006-05-04
			2020-07-10Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection - Final
			2009-08-01
			2020-07-10In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 - Final
			1999-12-01
			2020-07-10Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - Final
			2001-08-22
			2017-12-07Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts - Draft
			2002-11-02
			2015-05-08Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes - Draft
			2004-10-28
			2015-05-08Platelet Testing and Evaluation of Platelet Substitute Products - Draft
			1999-05-20
			2015-05-08Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products - Draft
			2008-02-11
			2015-05-08Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, & Cellular and Tissue-Based Products - Draft
			2009-03-26
			2015-05-08Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells - Draft
			2007-07-01
			2011-08-17Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research - Draft
			2001-08-23
			2010-08-09Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV) 3/1998" - Final
			1998-03-20
			1998-10-08


 
	Submit Comments
	   		  			  			Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All comments should be identified with the title of the guidance.

                                                                                  Content current as of:
      01/17/2023
         
                  
Regulated Product(s)
		 BiologicsSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 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