CBER - Letters to Industry, Healthcare Providers, Clinical Investigators


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Letters to Industry / Healthcare Providers / Clinical Investigators

2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 and earlier

horizonal rule
2003
Abbott Consent Decree Information -

Follow-up Letter to Abbott Laboratories - 12/18/2003

Abbott Labs Signs Consent Decree With FDA; Agrees to Correct Manufacturing Deficiencies - HHS News - 11/2/1999

Abbott Consent Decree of Permanent Injunction - 11/2/1999 - (PDF)

Dear Colleague Letter - Consent Decree With Abbott Laboratories - 11/3/1999 - (PDF), (Text)

Q's and A's - Abbott's In Vitro Diagnostic Products - Revised 11/17/1999 (PDF), (Text)

Devices Which Can Be Sold or Distributed in the United States and Internationally After December 6, 1999 - 11/16/1999 - (PDF)

Devices Not To Be Sold or Distributed By Abbott After December 6, 1999 in the United States, But Are Available Internationally - 11/16/1999 - (PDF)

US District Court for Illinois Order Dated 11/19/1999; Abbott Consent Decree - Amendment of Effective Date - (PDF)

Center for Devices and Radiological Health (CDRH) Consent Decree Information

Dear Manufacturer: Immune Globulin Intravenous (Human) (IGIV); Class Label Extension - 12/1/2003 - (Text)

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

2002
Dear Colleague Letter - Procedures for requesting CBER staff to participate in meetings, conferences, panels and workshops - 6/10/2002 - (PDF)
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)

Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with NonHuman Animal Cells

Lymphocyte Immune Therapy (LIT) Letter - 1/30/2002 - (Text), (PDF)
Note: the correct CBER contact telephone number is 301-827-5102

2001
Transfusion Related Acute Lung Injury Letter - 10/19/2001 - (Text), (PDF) (Updated)
Letter on Stem Cells to Senator Kennedy - 9/5/2001
Letter on Stem Cells to Senator Gregg - 9/5/2001
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 - (Text)
Letter to Associations - Cloning Technology - 3/28/2001 - (PDF), (Text)

Letter to Sponsors Using Vero Cells as a Cell Substrate for Investigational Vaccines - 3/12/2001 - (PDF), (Text)
Letter to Peter K. Law, Ph.D. - Cell Therapy Research Foundation - Cultured Allogeneic Myoblasts and Cyclosporin - 1/11/2001 - (Text)

2000
Letter to Sponsors / Researchers - Fetal Cellular or Tissue Products In Human Clinical Studies - 11/30/2000 - (PDF), (Text)
Consent Decree Notification Letter - Parkedale Pharmaceuticals, Inc. - 9/27/2000 - (PDF), (Text)

Consent Decree Notification Letter - Parkedale Pharmaceuticals, Inc. - 3/10/2000 - (PDF), (Text)

Dear Colleague Letter to Transplant Centers: Allogeneic Pancreatic Islets for Transplantation - 9/8/2000 - (PDF), (Text)
Letter to Vaccine Manufacturers Regarding Plans for Continued Use of Thimerosal as a Vaccine Preservative - Update - 5/31/2000 - (PDF), (Text)

Letter to Vaccine Manufacturers Regarding Plans for Continued Use of Thimerosal as a Vaccine Preservative - 7/1/1999 - (PDF), (Text)

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

Attachment - 9CFR94.18 Restrictions on importation of meat and edible products from ruminants due to bovine spongiform encephalopathy - (PDF) (Text)

Dear Gene Therapy IND or Master File Sponsor Letter - 3/6/2000 - (PDF), (Text)

New Initiatives to Protect Participants in Gene Therapy Trials - HHS News - 3/7/2000

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 - (PDF) (Text)

Previous requirements - 11/13/1998 - (PDF) (Text)

1999
Dear Manufacturer: Effect of Y2K on availability of medical products, including drugs, biologics and medical devices - 12/14/1999 - (PDF)
Disclosure of Information - OTC Gene Therapy - 12/1/1999 - (PDF) (Text)
Dear Gene Therapy IND Sponsor / Principal Investigator Letter - 11/5/1999 - (PDF), (Text)
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 - (PDF), (Text)
False Negative Results With Use of Unapproved HIV Rapid Home-Use Test Kit - EZ MedTest - 7/06/1999

Dear President / CEO / Blood Establishment Director: Year 2000 (Y2K) - 6/30/1999 - (PDF), (Text)
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 - 3/2399
Dear Colleague Letter: Voluntary Recall of Tripedia, DTaP Vaccine - 2/4/1999 - (PDF), (Text)

1998
Letter to Viral Vaccine IND Sponsors - Use of PCR-based Reverse Transcriptase Assay - 12/14/1998 - (PDF), (Text)
Dear IVD Manufacturer: In-vitro (IVD) test kits labeled for the detection of infectious agents in blood products - 11/13/1998 - (PDF), (Text)
Dear Doctor Letter - Important Drug Warning: Immune Globulin Intravenous (Human) - 11/13/1998 - (PDF), (Text)
Dear Blood Bank/Transfusion Service Director Letter: Hepatitis C Virus Risk - 11/3/1998 - (PDF), (Text)
Dear Colleague Letter - Use of Haemophilus influenzae Conjugate Vaccines in Combination With DTaP in Infants - 8/12/1998 - (PDF), (Text)
Dear Doctor Letter - Albumin Use in Seriously Ill Patients - 8/19/1998 - (PDF), (Text)
Dear Doctor Letter - Standardized Grass Pollen Extracts - 5/11/1998 - (PDF), (Text)
Dear Doctor Letter - Difficulty in Obtaining Immune Globulin Intravenous (Human) - 1/28/1998 - (PDF), (Text)

1997 and earlier
Letter to Allergenic Extract Manufacturers - Standardized Grass Pollen Extracts - 12/23/1997 - (PDF), (Text)
Letter to Plasma Fractionators - CBER's view on product recalls conducted by the plasma fractionation industry - 5/29/1997 - (PDF), (Text)
Letter to Biologic Product Manufacturers - Withdrawal of Human Blood-Derived Materials Because Donors Diagnosed With, or At Increased Risk For, CJD - 12/11/1997 - (PDF)
Letter to Manufacturers on Labeling Review Procedures - 12/3/1996 - (Text)
Letter to Manufacturers of Immune Globulin Intravenous (Human)(IGIV), Aseptic Meningitis Syndrome - 10/3/1994 - (Text)
Letter to Sponsors of an IND Using a Retroviral Vector - 9/20/1993 - (Text)