Information Sheets
2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997
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Testing Yourself for HIV-1, the Virus that Causes AIDS - 4/4/2006
Heterogeneity of Alpha-1-Proteinase Inhibitor Products - 3/27/2006
Varicella Zoster Immune Globulin (VZIG) - Anticipated Short Supply - 9/20/2005 - Information update - 11/29/2005
Safety of Albumin Administration in Critically Ill Patients - 5/16/2005
None issued in 2004
Update on Particulate Matter in Blood Bags - 10/31/2003
Monkeypox Virus Infections and Blood and Plasma Donors - 6/13/2003
Tissue Banks: The Dangers of Tainted Tissues and the Need for Federal Regulation - 5/14/2003
Development of a Novel Vaccinia Neutralization Assay Based on Reporter Gene Expression - 4/17/2003
Frequently Asked Questions on FDA's Continuing Investigation of Particulate Matter in Blood - 2/27/2003
Information Alert on Particulate Matter in Blood Bags - 2/7/2003
FDA Interim Statement Regarding Immune Globulin Intravenous (IGIV) - 8/27/2002
Important Recall Information Relating to Immune Globulin Intravenous (Human) - (Bayer Corp) - 3/20/2002, Updated 3/21/2002
Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with NonHuman Animal Cells - 3/8/2002
- Human Cells or Tissues Intended for Transplant Into a Human Recipient That Have Ex-vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs Letter - 3/8/2002 - (Text), (PDF)
Revised FDA Policy Statement on Urgent Collection, Shipment, and Use of Whole Blood and Blood Components Intended for Transfusion - 9/14/2001
- FDA Policy Statement on Urgent Collection, Shipment, and Use of Whole Blood and Blood Components Intended for Transfusion to Address Blood Supply Needs in the Current Disaster Situation - 9/11/2001
Availability of Abbott / Murex Single Use Diagnostic System (SUDS) HIV-1 Test - 5/10/2001
Availability of Abbott / Murex Single Use Diagnostic System (SUDS) HIV-1 Test - 10/18/2000
- Murex SUDS HIV-1 (Rapid EIA) - MedWatch - 10/18/2000
Human Gene Therapy and The Role of the Food & Drug Administration - 9/2000
FEDERAL REGISTER Temporary Deferment of Activities Relating to Certain Biological Submissions - 6/22/2000
(PDF), (Text)
- Resumption of Action After Temporary Deferment - 7/18/2000
- Temporary Deferment of Action on Certain Submissions - CBER requests that applicants voluntarily refrain from filing BLAs, PLAs, ELAs and related correspondence between June 26, 2000 and July 20, 2000
- Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits and Trays - CDRH Letter - 3/29/2000
- Clinipad Recall Further Information - MedWatch - 3/10/2000
- FDA Alerts Health Professionals and Consumers to Nationwide Recall of Clinipad Antiseptic Sterile Products - HHS NEWS - 3/10/2000
- Recall of Sterile Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol, and Alcohol Antiseptic Products as Well as Sterile Cliniguard® Protective Dressing, and Specified Lots of Nonsterile Products - 3/9/2000
Testing Yourself for HIV-1, the Virus that Causes AIDS - 5/6/1999, Updated 4/4/2006
- Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV) - 3/20/1998 - (PDF), (Text)
Team Biologics - A Plan for Reinventing FDA's Ability to Optimize Compliance of Regulated Biologics Industries - 7/30/1997 - (PDF), (Text)
Testing Yourself for HIV-1, the Virus that Causes AIDS - 5/9/1997, Updated 7/25/1997
FDA/CDC Warn Against Blood Donations by Those Possibly Exposed to Tick-Borne Illnesses - 7/18/1997
Recall of Blood Products In Six States Due to Risk of Tick-Borne Illnesses - 7/3/1997
Statement on Intermountain Health Care, Inc - 4/26/1997
FDA Warns Michigan Biologic Products Institute of Intention to Revoke Licenses - 3/10/1997