Vaccines, Blood & Biologics
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Safety & Availability (Biologics)
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2012
Information for Blood Establishments: Unavailability of CHIRON® RIBA® HCV 3.0 SIA (RIBA) FDA Safety Communication: Safety risk from reproductive tissue at the Center for Reproductive Medicine of Lutz, Florida Extension of Expiration Date for Black Widow Spider Antivenin Lot 0667018 (in packaged lot 0585Z) until February 12, 2013 And Instructions for Diluent Use Biologics Product Shortages Q&A Frequently Asked Questions about Minimally Manipulated, Unrelated Cord Blood Products for Clinical Use How FDA Ensures the Safety of Blood Products
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2010
New study on the detection of murine leukemia virus-related virus gene sequences in the blood of patients with chronic fatigue syndrome (CFS) and healthy blood donors - Questions and Answers FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices FDA Public Health Notification: Newborn Blood Banking, Inc.
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2009
Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine) Lot 4030026 Through October 31, 2012 FDA Public Health Notification: Vista Cord, LLC Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring Gardasil Vaccine Safety Information about Newly Emerging 2009 H1N1 Influenza Virus and Blood Safety
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2008
Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine) Lot 4030026 Through October 31, 2012
10/20/2009 - Dating period extended from 10/31/2009 to 10/31/2010Information About Heparin and Plasma Derived Products Danger Giving Topical Thrombin Intravascularly Pregnancy & Lactation Labeling FDA's Sentinel Initiative A proactive system to augment the Agency's current surveillance capabilities for FDA-regulated products Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product Important Safety Information: Dosing and Administration of Immune Globulin (Human), GamaSTANT S/D Packaged in 2-ml Syringes Vaccine Safety (CDC)
What Clinicians Need to Know About MMRV Vaccine SafetyImportant Safety Information: Dosing and Administration of Rabies Immune Globulin (Human), HyperRAB™ S/D Packaged in 2-ml Syringes
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2007
Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedvaxHIB� and Comvax�) PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine FDA Statement on Gene Therapy Clinical Trial Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products FDA Public Health Notification: Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way FDA Public Health Notification: Information on RotaTeq and Intussusception Postmarketing Monitoring of Intussusception After RotaTeq™ Vaccination
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2006
FDA and CDC Update Information on Menactra Meningococcal Vaccine and Guillain Barre Syndrome MMWR - Guillain-Barr� Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine FDA Public Health Notification: Donor Referral Services FDA Public Health Notification: Update of Information about BioMedical Tissue Services Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005 - 2006 (CDC) Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF) Varicella Zoster Immune Globulin (VZIG) Anticipated Short Supply and Alternate Product Availability Under an Investigational New Drug Application Expanded Access Protocol
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2005
Important Safety Alert: BacT/ALERT BacT/VIEW Users NovoSeven Coagulation Factor VIIa (Recombinant) Guillain-Barr� Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine - United States, June-July 2005 FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome DIC following Rho(D) Immune Globulin Intravenous Administration Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia or Hemoglobinuria following Rho(D) Immune Globulin Intravenous Administration for Immune Thrombocytopenic Purpura (PDF - 68KB)Safety of Albumin Administration in Critically Ill Patients Dear Doctor Letter - Albumin Use in Seriously Ill Patients Unapproved Home - Use Diagnostic Kits Marketed by Globus Media Recall of Rapid HIV Test Kits-Globus Media, Inc FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - Talkpaper Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics
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2004
Potential Hemolysis in Red Blood Cells and Whole Blood (Update) Potential Hemolysis in Red Blood Cells Whole Blood Increased Rate of Initial and/or Repeat Reactive Results for the Auszyme Monoclonal Test for Hepatitis B Surface Antigen (HBsAg) Notification Regarding Platelets, Pheresis Collection Using the Gambro Trima Accel Automated Blood Collection System Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine
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2003
Update on Particulate Matter in Blood Bags Women with Smallpox Vaccine Exposure During Pregnancy Reported to the National Smallpox Vaccine in Pregnancy Registry FDA Current Thinking on Irradiating and/or Freezing Blood Components Collected and Stored in Anticoagulant/Preservative Solutions Not Specifically Approved for Such Use Frequently Asked Questions on FDA's Continuing Investigation of Particulate Matter in Blood Information Alert on Particulate Matter in Blood Bags
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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