Vaccines, Blood & Biologics
Letters to Industry / Healthcare Providers / Clinical Investigators
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 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
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
Lymphocyte Immune Therapy (LIT) Letter - January 30, 2002
2001
Transfusion Related Acute Lung Injury Letter - October 19, 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
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
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Food and Drug Administration
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