* Biologics Post-Market Activities
* Biologic Product Security
* Biologic Product Shortages
* Compliance Programs (CBER)
* Impact of Severe Weather Conditions on Biological Products
* Importing & Exporting (Biologics)
* Lot Distribution Database (LDD)
* Product Surveillance (CBER)
* Recalls (Biologics)
* Report a Problem to the Center for Biologics Evaluation & Research
* Safety & Availability (Biologics)
* Untitled Letters (CBER)
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Recalls & Alerts
* Recalls (Biologics)
* Biologic Product Shortages
* Report a Problem to the Center for Biologics Evaluation & Research
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* Biologics Products & Establishments
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More Information
* For Industry
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Contact Us
* (800) 835-4709
* (301) 827-1800
* matt@fda.hhs.gov
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Manufacturers Assistance and Technical Training Branch (CBER)
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-41
Rockville, MD 20852-1448
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Saturday, June 20, 2009
Blood & Blood Products
The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events.
CBER works closely with other parts of the Public Health Service (PHS) to identify and respond to potential threats to blood safety, to develop safety and technical standards, to monitor blood supplies and to help industry promote an adequate supply of blood and blood products.
Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products:
* Blood donors are now asked specific and very direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates approximately 90 percent of unsuitable donors.
* FDA requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them.
* Blood donations are tested for seven different infectious agents.
In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry:
* FDA inspects all blood facilities at least every two years, and "problem" facilities are inspected more often.
* Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers.
While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been. As biological products, blood and blood products are likely always to carry an inherent risk of infectious agents. Therefore, zero risk may be unattainable. The role of FDA is to drive that risk to the lowest level reasonably achievable without unduly decrea
CBER works closely with other parts of the Public Health Service (PHS) to identify and respond to potential threats to blood safety, to develop safety and technical standards, to monitor blood supplies and to help industry promote an adequate supply of blood and blood products.
Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products:
* Blood donors are now asked specific and very direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates approximately 90 percent of unsuitable donors.
* FDA requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them.
* Blood donations are tested for seven different infectious agents.
In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry:
* FDA inspects all blood facilities at least every two years, and "problem" facilities are inspected more often.
* Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers.
While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been. As biological products, blood and blood products are likely always to carry an inherent risk of infectious agents. Therefore, zero risk may be unattainable. The role of FDA is to drive that risk to the lowest level reasonably achievable without unduly decrea
Biographical Sketch, John Kilbourne, M.D.
Title: Medical Officer
Office:
National Library of Medicine
National Institutes of Health
Bldg. 38A, Room B2E17
8600 Rockville Pike
Bethesda MD 20894 USA
Telephone:
(301) 594-2897 (voice)
(301) 402-2002 (fax)
Electronic mail:
kilbourj@mail.nih.gov
John received his M.D. degree from the University of Illinois College of Medicine. After completing his Family Medicine residency and practicing near Chicago, he joined the SNOMED division of the College of American Pathologists as a clinical editor. His role there expanded to include implementation training, and in 2005 he joined the NLM.
Biographical Sketch, Dan-Sung C. Cho
Title:
Technical Information Specialist
Office:
National Library of Medicine
National Institutes of Health
Bldg. 38A, Room B2E17
8600 Rockville Pike
Bethesda MD 20894 USA
Telephone:
(301) 301-594-2086 (voice)
(301) 402-2002 (fax)
Electronic mail:
mailto:chodan@mail.nlm.nih.gov
Dan Cho joined the Medical Subject Headings Section in July 2008. He earned his undergraduate degree in Biology from Texas A&M University and has a Ph.D. degree in Genetics from North Carolina State University.
He received postdoctoral training at the Wistar Institute where his main research interest included RNA editing enzyme and RNAi mechanisms. Prior to arriving at the Medical Subject Headings Section, he was involved in molecular etiology of Schizophrenia and Bipolar disorders and held the position of a Research Scientist at the University of Pennsylvania, School of Medicine. He also examined US patent applications on DNA technology at the US PTO.
Biographical Sketch, Stuart J. Nelson, M.D.
Title:
Head, Medical Subject Headings Section
Office:
National Library of Medicine
National Institutes of Health
Bldg. 38A, Room B2E17
8600 Rockville Pike
Bethesda MD 20894 USA
Telephone:
(301) 496-1495 (voice)
(301) 402-2002 (fax)
Electronic mail:
nelson@nlm.nih.gov
Stuart J. Nelson, MD, was born and raised in California. His undergraduate education was at the University of California at Berkeley. He took a Bachelor's degree in Mathematics in 1970, and moved to Brooklyn, New York, to attend medical school at the State University of New York.
After obtaining the MD degree, he interned at Philadelphia General Hospital on the University of Pennsylvania's medical service, and completed a residency in Internal Medicine at Metropolitan Hospital Center in New York City. He was certified by the American Board of Internal Medicine in 1978. From 1978 to 1991, he served on the faculty of the State University of New York at Stony Brook. In 1991 he moved to the Medical College of Georgia.
His research interests are in the area of computer applications to medicine, and he collaborated for several years with Dr. Marsden S. Blois, one of the founders of the field of Medical Informatics. He is a Fellow of the American College of Physicians and a Fellow of the American College of Medical Informatics.
In 1996 he came to the National Library of Medicine as the Head of the Medical Subject Headings Section. He has published extensively in the field of medical informatics, especially in the area of computerized vocabularies.
Keeping Your Health Care Professional Informed
It's important to keep your health care professional updated about your progress on PRISTIQ and informed about any changes to your health and other medications you may be taking, including prescription and over-the-counter medications.
Before taking PRISTIQ, talk to your health care professional about:
All your medical conditions, especially if you have or have had high blood pressure, heart problems, high cholesterol or high triglycerides, a history of stroke, glaucoma, kidney problems, liver problems, seizures or convulsions, mania or bipolar disorder, or low sodium levels in your blood.
– Your health care professional should check your blood pressure regularly while you are taking PRISTIQ.
Taking PRISTIQ if you are nursing, pregnant, or plan to become pregnant, as it is not known if PRISTIQ will harm your unborn baby.
All prescription and over-the-counter medications you are taking or plan to take, including:
– Medicines to treat migraines or mood disorders, to avoid a potentially life-threatening condition.
– Aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.
Keep a list of all medications you have taken or plan to take to show your health care professional.
Do not start new medications without first checking with your health care professional.
Stopping an antidepressant medicine, especially suddenly, can cause side effects called discontinuation symptoms. Your health care professional may want to decrease your dose slowly to help avoid these side effects. Therefore, do not stop taking or change the dose of PRISTIQ without first talking to your health care professional, even if you feel better. Only your health care professional can tell you how long you should use PRISTIQ.
Before taking PRISTIQ, talk to your health care professional about:
All your medical conditions, especially if you have or have had high blood pressure, heart problems, high cholesterol or high triglycerides, a history of stroke, glaucoma, kidney problems, liver problems, seizures or convulsions, mania or bipolar disorder, or low sodium levels in your blood.
– Your health care professional should check your blood pressure regularly while you are taking PRISTIQ.
Taking PRISTIQ if you are nursing, pregnant, or plan to become pregnant, as it is not known if PRISTIQ will harm your unborn baby.
All prescription and over-the-counter medications you are taking or plan to take, including:
– Medicines to treat migraines or mood disorders, to avoid a potentially life-threatening condition.
– Aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.
Keep a list of all medications you have taken or plan to take to show your health care professional.
Do not start new medications without first checking with your health care professional.
Stopping an antidepressant medicine, especially suddenly, can cause side effects called discontinuation symptoms. Your health care professional may want to decrease your dose slowly to help avoid these side effects. Therefore, do not stop taking or change the dose of PRISTIQ without first talking to your health care professional, even if you feel better. Only your health care professional can tell you how long you should use PRISTIQ.
Keeping Your Health Care Professional Informed
It's important to keep your health care professional updated about your progress on PRISTIQ and informed about any changes to your health and other medications you may be taking, including prescription and over-the-counter medications.
Before taking PRISTIQ, talk to your health care professional about:
All your medical conditions, especially if you have or have had high blood pressure, heart problems, high cholesterol or high triglycerides, a history of stroke, glaucoma, kidney problems, liver problems, seizures or convulsions, mania or bipolar disorder, or low sodium levels in your blood.
– Your health care professional should check your blood pressure regularly while you are taking PRISTIQ.
Taking PRISTIQ if you are nursing, pregnant, or plan to become pregnant, as it is not known if PRISTIQ will harm your unborn baby.
All prescription and over-the-counter medications you are taking or plan to take, including:
– Medicines to treat migraines or mood disorders, to avoid a potentially life-threatening condition.
– Aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.
Keep a list of all medications you have taken or plan to take to show your health care professional.
Do not start new medications without first checking with your health care professional.
Stopping an antidepressant medicine, especially suddenly, can cause side effects called discontinuation symptoms. Your health care professional may want to decrease your dose slowly to help avoid these side effects. Therefore, do not stop taking or change the dose of PRISTIQ without first talking to your health care professional, even if you feel better. Only your health care professional can tell you how long you should use PRISTIQ.
Before taking PRISTIQ, talk to your health care professional about:
All your medical conditions, especially if you have or have had high blood pressure, heart problems, high cholesterol or high triglycerides, a history of stroke, glaucoma, kidney problems, liver problems, seizures or convulsions, mania or bipolar disorder, or low sodium levels in your blood.
– Your health care professional should check your blood pressure regularly while you are taking PRISTIQ.
Taking PRISTIQ if you are nursing, pregnant, or plan to become pregnant, as it is not known if PRISTIQ will harm your unborn baby.
All prescription and over-the-counter medications you are taking or plan to take, including:
– Medicines to treat migraines or mood disorders, to avoid a potentially life-threatening condition.
– Aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.
Keep a list of all medications you have taken or plan to take to show your health care professional.
Do not start new medications without first checking with your health care professional.
Stopping an antidepressant medicine, especially suddenly, can cause side effects called discontinuation symptoms. Your health care professional may want to decrease your dose slowly to help avoid these side effects. Therefore, do not stop taking or change the dose of PRISTIQ without first talking to your health care professional, even if you feel better. Only your health care professional can tell you how long you should use PRISTIQ.
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