Information Sheets

2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997

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2006

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 and Alternate Product Availability under an Investigational New Drug Application Expanded Access Protocol - 2/8/2006

2005

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

Dear Doctor Letter - Albumin Use in Seriously Ill Patients - 8/19/1998

2004

None issued in 2004

2003

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

FDA Current Thinking on Irradiating and/or Freezing Blood Components Collected and Stored in Anticoagulant/Preservative Solutions Not Specifically Approved for Such Use - 3/5/2003

Frequently Asked Questions on FDA's Continuing Investigation of Particulate Matter in Blood - 2/27/2003

Update on FDA's Continuing Investigation of Particulate Matter in Blood Shows Normal Blood Components and No Evidence for an Increase in Adverse Events - 2/27/2003

Information Alert on Particulate Matter in Blood Bags - 2/7/2003

FDA Recommends Temporary Additional Blood Inspection Measures as it Continues Investigation of Reports of White Particulate Matter in Some Units of Blood and Blood Components - 2/7/2003

2002

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)

2001

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

2000

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

1999

Testing Yourself for HIV-1, the Virus that Causes AIDS - 5/6/1999, Updated 4/4/2006

1998

Withdrawal of "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)" - 9/8/1998

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)

Change to the Guidance Entitled "Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products" - 9/8/1998

1997

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