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FDA Warns of Safety Concern Regarding Rituxan in New Patient Population
Rituxan central nervous system immune system
2006/12/26
December 18, 2006,The Food and Drug Administration (FDA) is alerting health care professionals and patients treated with Rituxan (rituximab) to reports of an emerging risk of a serious side effect in ...
FDA Approves First Test to Screen Blood Donors for Chagas Disease
Blood Donors Chagas disease
2006/12/26
December 13, 2006,The U.S. Food and Drug Administration (FDA) today approved a new test to screen blood donors for a blood-borne parasite that causes Chagas disease, a serious and potentially fatal pa...
FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs
Experimental Drugs
2006/12/26
December 11, 2006，The Food and Drug Administration (FDA) today proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients with no oth...
FDA Approves Novel Device That Prevents or Reduces Brain Damage in Infants
hypoxic-ischemic encephalopathy Cool-Cap system Infants
2006/12/26
December 20, 2006，The Food and Drug Administration (FDA) today approved a first-of-a-kind medical device for the treatment of babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE),...
December 11, 2006,The Food and Drug Administration (FDA) today ordered firms to stop marketing unapproved drug products containing quinine, a drug used to treat malaria, citing serious safety concerns...
December 12, 2006，The U.S. Food and Drug Administration (FDA) is currently working with five states and the Centers for Disease Control and Prevention to investigate an outbreak of norovirus which has...
FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations
Trasylol safety warnings Pharmaceuticals
2006/12/26
December 15, 2006，The U.S. Food and Drug Administration (FDA) today approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to sp...
Deputy Commissioner for Medical and Scientific Affairs to Leave FDA
Scott Gottlieb medicine
2006/12/26
December 11, 2006，Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration announced today that he will leave the agency effective January 16, 200...
FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers
Pain acetaminophen nonsteroidal aspirin
2006/12/26
December 19, 2006，The Food and Drug Administration (FDA) today proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug produ...
FDA Approves Treatment for Children and Teens With Mildly to Moderately Active Ulcerative Colitis
Ulcerative colitis pediatric
2006/12/26
December 20, 2006，The Food and Drug Administration (FDA) today approved Colazal (balsalazide disodium) for the treatment of mildly to moderately active ulcerative colitis in patients 5 to 17 years of ...
December 20, 2006，The Food and Drug Administration (FDA) today approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia. Paliperidone is a new molecular entity, which...
December 15, 2006，The Food and Drug Administration (FDA) today approved Cyanokit (containing the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with ...
FDA Updates its Nationwide Alert on Counterfeit One Touch Blood Glucose Test Strips
Glucose test strips
2006/12/26
December 15, 2006，The U.S. Food and Drug Administration (FDA) is providing an update to its notifications on October 13, and October 23, 2006, alerting the public to counterfeit blood glucose test str...
美国FDA专家来中国兽医药品监察所技术交流（图）
兽医药品 耐药性 耐药机理
2006/11/7
根据国家外专局2006年引智项目，中监所检测技术研究室邀请了美国食品药品管理局兽医中心（FDA，CVM）主任Dr. Robert D. Walker和Dr. Shaohua Zhao于2006年10月8日至10月18日到我所技术交流。中监所检测技术研究室和科技处于2006年10月11--12日承办了“耐药性监测系统运行与耐药性评估论坛”。Dr. Robert D. Walker和Dr. Shaoh...