Letters to Industry / Healthcare Providers / Clinical Investigators

2009

Dear Health Care Provider Letter: North American Coral Snake Antivenin (Micrurus fulvius) (Equine) Lot 4030026 (PDF - 86 KB) - 10/23/2009

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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 - 1/30/2002

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2001

Transfusion Related Acute Lung Injury Letter - 10/19/2001  

Letter to Sponsors / Researchers - Human Cells Used in Therapy Involving the Transfer of Genetic Material By Means Other Than the Union of Gamete Nuclei - 7/6/2001

Letter to Associations - Cloning Technology - 3/28/2001

Letter to Sponsors Using Vero Cells as a Cell Substrate for Investigational Vaccines - 3/12/2001

Letter to Peter K. Law, Ph.D. - Cell Therapy Research Foundation - Cultured Allogeneic Myoblasts and Cyclosporin - 1/11/2001

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2000

Letter to Sponsors / Researchers - Fetal Cellular or Tissue Products In Human Clinical Studies - 11/30/2000

Consent Decree Notification Letter - Parkedale Pharmaceuticals, Inc. - 3/10/2000

Dear Colleague Letter to Transplant Centers: Allogeneic Pancreatic Islets for Transplantation - 9/8/2000

To Manufacturers of Biological Products: Recommendations Regarding Bovine Spongiform Encephalopathy (BSE) - 4/19/2000

Dear Gene Therapy IND or Master File Sponsor Letter - 3/6/2000

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 - 2/17/2000

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1999

Dear Manufacturer: Effect of Y2K on availability of medical products, including drugs, biologics and medical devices - (PDF - 137 KB) - 12/14/1999

Disclosure of Information - OTC Gene Therapy - 12/1/1999

Dear Gene Therapy IND Sponsor / Principal Investigator Letter - 11/5/1999

Dear Doctor Letter IMPORTANT DRUG WARNING - Potential risk of ACUTE RENAL FAILURE reported to be associated with administration of Immune Globulin Intravenous (Human) - 9/24/1999

Letter to Vaccine Manufacturers Regarding Plans for Continued Use of Thimerosal as a Vaccine Preservative - 7/1/1999

Dear President / CEO / Blood Establishment Director: Year 2000 (Y2K) - 6/30/1999

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

CBER Dear Colleague Letter - FDAMA Section 406(b): Communicating with Our Stakeholders - 3/23/1999

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1998

Letter to Viral Vaccine IND Sponsors - Use of PCR-based Reverse Transcriptase Assay - 12/14/1998

Dear Manufacturer: Requirements for In-vitro Diagnostic (IVD) Test Kits Labeled for the Detection of Infectious Agents in Blood Products - 11/13/1998

Dear Doctor Letter - Important Drug Warning: Immune Globulin Intravenous (Human) - 11/13/1998

Dear Blood Bank/Transfusion Service Director Letter: Hepatitis C Virus Risk - 11/3/1998

Dear Colleague Letter - Use of Haemophilus influenzae Conjugate Vaccines in Combination With DTaP in Infants - 8/12/1998

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

Dear Doctor Letter - Standardized Grass Pollen Extracts - 5/11/1998

Dear Doctor Letter - Difficulty in Obtaining Immune Globulin Intravenous (Human) - 1/28/1998

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1997 and earlier

Letter to Allergenic Extract Manufacturers - Standardized Grass Pollen Extracts - 12/23/1997

Letter to Plasma Fractionators - CBER's view on product recalls conducted by the plasma fractionation industry - 5/29/1997

Letter to Biologic Product Manufacturers - Withdrawal of Human Blood-Derived Materials Because Donors Diagnosed With, or At Increased Risk For, CJD - (PDF - 753 KB) - 12/11/1997

Letter to Manufacturers on Labeling Review Procedures - 12/3/1996

Letter to Manufacturers of Immune Globulin Intravenous (Human)(IGIV), Aseptic Meningitis Syndrome - 10/3/1994

Letter to Sponsors of an IND Using a Retroviral Vector - 9/20/1993