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GUIDANCE DOCUMENT

Withdrawn Guidances (Biologics) January 2017

Final
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

 

Title Date Issued
(year-month-day)  
Date Withdrawn
(year-month-day) 

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

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

Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research - Draft

2001-08-23

2010-08-09

 


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.

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