• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Letters to Industry / Healthcare Providers / Clinical Investigators

 

 

 

 

 2013

Dear Healthcare Provider Letter: IMPORTANT CHANGE IN BabyBIG® PRESCRIBING INFORMATION (PDF - 540KB) - September 23, 2013

Dear Healthcare Provide Letter:  FURTHER EXTENSION OF EXPIRATION DATING TO October 31, 2014 LOT N0. 4030026, Antivenin (Micrurus fulvius) (Equine Origin) North American Coral Snake Antivenin (PDF- 127KB) - August 16, 2013


 2012

Dear Health Care Provider Letter: Further Extension of Expiration Dating to April 2014, LOT NO.4030024 - December 7, 2012

Dear Healthcare Provider Letter: Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot 4030026 Through October 31, 2013 - September 4, 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

 


 

2011

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


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 


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 


2003

Abbott Consent Decree Information

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


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


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


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


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


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


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

 


 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002