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Regulatory Focus™ > News Articles > 2020 > 7 > CBER withdraws 20 draft and final guidances

CBER withdraws 20 draft and final guidances

Posted 13 July 2020 | By Michael Mezher 

CBER withdraws 20 draft and final guidances

Last week, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) withdrew 20 draft and final guidances, more than half of which date back to the 1980s and 1990s.
Many of the withdrawn guidances relate to blood and blood products, donor screening and HIV. Among the guidances are a Y2K-era guidance on handling the year 2000 date change for computer systems and software applications used to manufacture blood products and a 2003 guidance on screening donors for severe acute respiratory syndrome (SARS).
Withdrawn CBER guidances
Title Issued
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances - Final June 1980
Guideline for the Uniform Labeling of Blood and Blood Components - Final August 1985
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 August 1989
Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors) - Final October 1989
Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin) – Final January 1992
Recommended Methods for Blood Grouping Reagents Evaluation - Draft March 1992
Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin – Draft March 1992
Guideline for Quality Assurance in Blood Establishments - Final July 1995
Screening and Testing of Donors of Human Tissue Intended for Transplantation - Final July 1997
Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products - Final January 1998
Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing - Final June 1998
Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans – Final April 1999
Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens – Final June 2000
Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - Final November 2000
Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts – Final November 2000
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 September 2003
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 January 2004
Development of Preventive HIV Vaccines for Use in Pediatric Populations – Final May 2006
Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection - Final August 2009
In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 – Final December 1999

Tags: biologics, CBER, US

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