Letters to Industry / Healthcare Providers / Clinical Investigators

2012

Dear Healthcare Professional: IMPORTANT PRODUCT SUPPLY INFORMATION: Antivenin (Latrodectus mactans) (Black Widow Spider Antivenin) Equine Origin, EXTENSION OF EXPIRATION DATING TO February 12, 2013 Lot Number 0667018, packaged in Lot 0585Z (PDF - 35KB) - August 13, 2012

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2011

Information for Health Care Professionals: Anticipated Short Supply of Coral Snake Antivenom (Pfizer Inc. ) - October 25, 2011 

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2010

Dear Health Care Provider Letter: Dosage And Administration Change For Hiberix® [Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)] (PDF - 103 KB) - December 16, 2010

Dear Health Care Provider: Important Information Re: Sanofi Pasteur's Adacel® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, and Decavac®, Tetanus and Diphtheria Toxiods Adsorbed in Prefilled Syringes (PDF - 70KB) - October 2010

Dear Health Care Provider Letter: Information Re Fluarix® (Influenza Virus Vaccine): Tip Caps Of The Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions in Latex Sensitive Individuals - August 16, 2010

Dear Health Care Provider Letter: Information Re: Hiberix (Haemophilus B Conjugate Vaccine [Tetanus Toxoid Conjugate]) Tip Caps Of The Prefilled Diluent Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions In Latex Sensitive Individuals - July 29, 2010

Dear Healthcare Provider Letter: Informtion Re: Engerix-B (Hepatitis B Vaccine (Recombinant)) Tip Caps of the Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions in Latex Sensitive Individuals - July 29, 2010

Dear Healthcare Provider Letter: Information Re: Havrix (Hepatitis A Vaccine) Tip Caps Of The Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions In Latex Sensitive Individuals - July 29, 2010

Dear Healthcare Provider Letter: Risk of thrombotic and thromboembolic events following infusion of  FEIBA VH or FEIBA NF -  July 2010

Dear Health Care Provider Letter: Fluvirin and Agriflu (Influenza Virus Vaccine) Pre-Filled Syringes - July 20, 2010

Information for Health Care Professionals: Anticipated Short Supply of Coral Snake Antivenom (Pfizer Inc.) - May 18, 2010 

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2009

Dear Health Care Provider Letter: North American Coral Snake Antivenin (Micrurus fulvius) (Equine) Lot 4030026 (PDF - 86 KB) - October 23, 2009

Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants (Baxter Healthcare Corporation) - October 5, 2009

FDA Safety Notification: Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants - Evicel - September 22, 2009 

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2003

Abbott Consent Decree Information

Dear Manufacturer: Immune Globulin Intravenous (Human) (IGIV); Required Updates to Product Labeling - 10/16/2003

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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

Lymphocyte Immune Therapy (LIT) Letter - January 30, 2002

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2001

Transfusion Related Acute Lung Injury Letter - October 19, 2001  

Letter to Sponsors / Researchers - Human Cells Used in Therapy Involving the Transfer of Genetic Material By Means Other Than the Union of Gamete Nuclei - July 6, 2001

Letter to Associations - Cloning Technology - March 28, 2001

Letter to Sponsors Using Vero Cells as a Cell Substrate for Investigational Vaccines - March 3, 2001

Letter to Peter K. Law, Ph.D. - Cell Therapy Research Foundation - Cultured Allogeneic Myoblasts and Cyclosporin - January 11, 2001

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2000

Letter to Sponsors / Researchers - Fetal Cellular or Tissue Products In Human Clinical Studies - November 30, 2000

Consent Decree Notification Letter - Parkedale Pharmaceuticals, Inc. - March 10/2000

Dear Colleague Letter to Transplant Centers: Allogeneic Pancreatic Islets for Transplantation - September 8, 2000

To Manufacturers of Biological Products: Recommendations Regarding Bovine Spongiform Encephalopathy (BSE) - April 19, 2000

Dear Gene Therapy IND or Master File Sponsor Letter - March 6, 2000

Dear Manufacturer: Revised requirements for the modification of product labeling nomenclature for controls and calibrators used in test kits labeled for the detection of infectious agents in blood products - February 17, 2000

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1999

Dear Manufacturer: Effect of Y2K on availability of medical products, including drugs, biologics and medical devices - (PDF - 137 KB) - December 14, 1999

Disclosure of Information - OTC Gene Therapy - December 1, 1999

Dear Gene Therapy IND Sponsor / Principal Investigator Letter - November 5, 1999

Dear Doctor Letter IMPORTANT DRUG WARNING - Potential risk of ACUTE RENAL FAILURE reported to be associated with administration of Immune Globulin Intravenous (Human) - September 24, 1999

Letter to Vaccine Manufacturers Regarding Plans for Continued Use of Thimerosal as a Vaccine Preservative - July 7, 1999

Dear President / CEO / Blood Establishment Director: Year 2000 (Y2K) - June 30, 1999

Dear Colleague Letter - Hypotension and Bedside Leukocyte Reduction Filters - May 5, 1999 - (Joint CBER, CDRH, CDER letter)

CBER Dear Colleague Letter - FDAMA Section 406(b): Communicating with Our Stakeholders - March 23, 1999

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1998

Letter to Viral Vaccine IND Sponsors - Use of PCR-based Reverse Transcriptase Assay - December 14, 1998

Dear Manufacturer: Requirements for In-vitro Diagnostic (IVD) Test Kits Labeled for the Detection of Infectious Agents in Blood Products - November 13, 1998

Dear Doctor Letter - Important Drug Warning: Immune Globulin Intravenous (Human) - November 13, 1998

Dear Blood Bank/Transfusion Service Director Letter: Hepatitis C Virus Risk - November 3, 1998

Dear Colleague Letter - Use of Haemophilus influenzae Conjugate Vaccines in Combination With DTaP in Infants - August 12, 1998

Dear Doctor Letter - Albumin Use in Seriously Ill Patients - August, 19, 1998

Dear Doctor Letter - Standardized Grass Pollen Extracts - May 5, 1998

Dear Doctor Letter - Difficulty in Obtaining Immune Globulin Intravenous (Human) - January 28, 1998

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1997 and Earlier

Letter to Allergenic Extract Manufacturers - Standardized Grass Pollen Extracts - November 23, 1997

Letter to Plasma Fractionators - CBER's view on product recalls conducted by the plasma fractionation industry - May 29, 1997

Letter to Biologic Product Manufacturers - Withdrawal of Human Blood-Derived Materials Because Donors Diagnosed With, or At Increased Risk For, CJD - (PDF - 753 KB) - December 11, 1997

Letter to Manufacturers on Labeling Review Procedures - December 3, 1996

Letter to Manufacturers of Immune Globulin Intravenous (Human)(IGIV), Aseptic Meningitis Syndrome - October 3, 1994

Letter to Sponsors of an IND Using a Retroviral Vector - September 20, 1993

 

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