Emergency Use Authorization for Vaccines to Prevent COVID-19 – Final
2022-03-31
2024-09-06
Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products – Final
2018-05-02
2024-05-20
Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency – Final
2022-01-21
2023-01-17
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components
2018-07-08
2021-05-12
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances – Final
1980-06-01
2020-07-10
Guideline for the Uniform Labeling of Blood and Blood Components – Final
1985-08-01
2020-07-10
Draft 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
2020-07-10
Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (“High Risk” Donors) – Final
1989-10-01
2020-07-10
Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin) – Final
1992-01-01
2020-07-10
Recommended Methods for Blood Grouping Reagents Evaluation – Draft
1992-03-01
2020-07-10
Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin – Draft
1992-03-01
2020-07-10
Guideline for Quality Assurance in Blood Establishments – Final
1995-07-11
2020-07-10
Screening and Testing of Donors of Human Tissue Intended for Transplantation – Final
1997-07-01
2020-07-10
Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products – Final
1998-01-08
2020-07-10
Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing – Final
1998-06-11
2020-07-10
Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans – Final
1999-04-06
2020-07-10
Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens – Final
2000-06-01
2020-07-10
Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens – Final
2000-06-01
2020-07-10
Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol – Final
2000-11-20
2020-07-10
Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts – Final
2000-11-20
2020-07-10
Revised 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
2020-07-10
Revised 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
2020-07-10
Development of Preventive HIV Vaccines for Use in Pediatric Populations – Final
2006-05-04
2020-07-10
Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection – Final
2009-08-01
2020-07-10
In 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
2020-07-10
Variances for Blood Collection from Individuals with Hereditary Hemochromatosis – Final
2001-08-22
2017-12-07
Precautionary 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
2015-05-08
Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes – Draft
2004-10-28
2015-05-08
Platelet Testing and Evaluation of Platelet Substitute Products – Draft
1999-05-20
2015-05-08
Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products – Draft
2008-02-11
2015-05-08
Use 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
2015-05-08
Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells – Draft
2007-07-01
2011-08-17
Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research – Draft
2001-08-23
2010-08-09
Supplemental 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
