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A Short Course on the Food and Drug Administration: What You Should Know
Short Course Food Drug Administration
2008/12/15
US government bureaucracy and regulatory agencies are thought of as pits of deep mystery to most scientists, but the regulatory issues are built on codes and precedent. The Food and Drug Administratio...
Food and Drug Administration Approves Expanded Use for Surgical Sealant
Evicel Fibrin Sealant blood vessels
2007/5/24
May 15, 2007，The U.S. Food and Drug Administration (FDA) today approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgica...
May 21, 2007，The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled ...
Food and Drug Administration Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
boxed warning magnetic resonance imaging liver disease
2007/5/24
May 23, 2007，The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhanc...
Food and Drug Administration Approves Contraceptive for Continuous Use
Contraceptive pregnancy
2007/5/24
May 22, 2007，The Food and Drug Administration (FDA) today approved Lybrel, the first continuous use drug product for prevention of pregnancy.
Food and Drug Administration Clears First Respirators for Use in Public Health Medical Emergencies
influenza pandemic public health
2007/5/9
May 8, 2007，The U.S. Food and Drug Administration (FDA) today cleared for marketing the first respirators that can help reduce the user’s exposure to airborne germs during a public health medical emer...
Food and Drug Administration and USDA Determine Swine Fed Adulterated Product
food supply swine
2007/4/28
April 26, 2007，The USDA Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) today notified State authorities that swine fed adulterated product will not be approv...
Food and Drug Administration Approves Product to Treat Common Bleeding Disorder
Humate-P von Willebrand disease bleeding
2007/4/28
April 27, 2007，The U.S. Food and Drug Administration (FDA) today approved Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) for the prevention of excessive bleeding during and after surge...
Food and Drug Administration Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia
Insomnia generic
2007/4/25
April 23, 2007，The U.S. Food and Drug Administration (FDA) today approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate is a sedat...
Food and Drug Administration Announces Audio Broadcasts on Emerging Drug Safety Information
health care Audio Broadcasts
2007/4/23
April 20, 2007，The U.S. Food and Drug Administration (FDA) is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information. Th...
US food and drug administration to Hold Public Hearing on Medication Guide Program
Medication Guide program pharmacies
2007/4/16
April 12, 2007，The Food and Drug Administration (FDA) will hold a public hearing on June 12 and 13, 2007, to obtain feedback on FDA’s Medication Guide program. Medication Guides are handouts given to ...
food and drug administration Urgently Warns Consumers about Health Risks of Potentially Contaminated Olives
botulinum olives
2007/4/16
April 13, 2007，The U.S. Food and Drug Administration (FDA) is alerting consumers to possible serious health risks from eating olives that may be contaminated with a deadly bacterium, Clostridium botul...
food and drug administration Licenses First Biologic Product to Prevent Hepatitis B Reinfection in Liver Transplant Patients
hepatitis B immune liver cancer Liver transplant
2007/4/11
April 6, 2007,The U.S. Food and Drug Administration (FDA) today announced the approval of HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant patients. HepaGam B is the...
food and drug administration Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide
Trimethobenzamide
2007/4/11
April 6, 2007,As part of the Food and Drug Administration's (FDA) on-going initiative to ensure that all marketed U.S. drugs have required marketing approval, the agency announced today that companies...
food and drug administration Announces Voluntary Withdrawal of Pergolide Products
Parkinson’s disease pergolide pharmacies
2007/3/30
March 29, 2007，The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these dru...