U.S. Lawmakers Probe FDA Approval of Ranbaxy Drugs
Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data. The congressional investigation stems from information released as part of a probe by U.S. law enforcement authorities into whether the Indian drugmaker submitted false data […]
FDA Approvals: KINRIX and Metvixia
The US Food and Drug Administration (FDA) has approved a combination vaccine that offers protection against diphtheria, tetanus, pertussis, and polio in a single shot; and the use of methyl aminolevulinate 16.8% cream with a narrow-band, red-light device equipped with light-emitting diodes for the treatment of actinic keratoses.
VICTORY: Medicare bill becomes law!
H.R. 6331 includes SGR fix, Teaching Rule reform In a historic triumph for ASA, a law has been enacted that will reverse Medicare payment cuts for 2008, provide a 1.1% positive update for 2009, and permanently restore full Medicare payment to anesthesiology teaching programs beginning in 2010! Earlier today President Bush vetoed H.R. 6331. This […]
HHS Announces New International Programs to Enhance Drug and Food Safety
Joint Inspections with European Union and Australian Regulators; Third-Party Certification Program Are Latest Steps toward Implementing New Import StrategyU.S. Health and Human Services (HHS) Secretary Mike Leavitt today announced two groundbreaking programs designed to enhance the safety of food and medical products exported to the United States.
Cymbalta® is now approved for fibromyalgia
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) indicated in adults for Acute and maintenance treatment of major depressive disorder (MDD) Management of diabetic peripheral neuropathic pain (DPNP) Treatment of acute generalized anxiety disorder (GAD) The management of fibromyalgia, with or without depression Although the mechanism of the antidepressant action of Cymbalta in […]
Merck’s Gardasil Not Cleared for Older Women
U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its HPV vaccine Gardasil to an older group of women, the drugmaker said Wednesday.
EU Agency Backs Schering-Plough Anaesthesia Drug
A new drug from Schering-Plough Corp aimed at helping patients emerge more quickly from anaesthesia has been recommended for approval in Europe, the region's medicines watchdog said on Monday.
Legislative Alert
Senate Finance Committee Chairman Max Baucus crafting legislation that would provide positive Medicare payment updates through 2009 and make other needed reforms
ASA comments at FDA hearing on fospropofol
The ASA submitted formal comments and testified before the Food and Drug Administration’s (FDA) Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) requesting that the labeling for fospropofol disodium injection 35 mg/ml (fospropofol) include a similar warning to that which is included on the label for propofol. Because fospropofol is a pro-drug of propofol and […]
Heparin Contamination Was Deliberate Act to Cut Costs?
Contamination of the worldwide heparin supply, which resulted in a substantial increase in adverse events and an estimated 81 deaths in the US, appears to have been a deliberate act to increase profits in Chinese workshops.
