GUIDANCE DOCUMENT
Withdrawn Guidances (Biologics) September 2024
| Title | Date Issued (year-month-day) |
Date Withdrawn (year-month-day) |
|---|---|---|
|
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 |
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.