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(CBER) withdrew 20 draft and final guidances, more than half of which date back to the 1980s and 1990s.Many of the withdrawn guidances relate to blood and blood products, donor screening and HIV.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| Withdrawn CBER guidances | |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 |