FDA

Abbott Labs wrongly pushed Depakote for dementia care, will pay $1.5 billion

May 07, 2012

Abbott Laboratories has pleaded guilty and agreed to pay $1.5 billion over allegations that it promoted the anti-seizure drug Depakote for uses that were not approved by the Food and Drug Administration.
 

FDA reauthorization bill passes Senate committee

April 27, 2012

A funding reauthorization bill that regulates the Food and Drug Administration cleared a hurdle Wednesday when a Senate committee approved it.
 

Mobile X-ray system gets federal approval

April 25, 2012

Carestream has received Food & Drug Administration clearance for its DRX-Revolution Mobile X-Ray System, the company announced. The firm is now accepting orders from healthcare facilities. This next-generation mobile DR system features outstanding image quality, easy maneuverability and comes with numerous productivity-enhancing features.
 

Higher dose of Alzheimer's drug approved despite FDA warnings, report shows

March 26, 2012

Makers of the Alzheimer's drug Aricept released a higher dosage version of the medication despite concerns about side effects and reduced efficacy, a study reports.
 

FDA approval for portable wound care device

March 20, 2012

Now that the Food & Drug Administration has approved Smith and Nephew's PICO device for the treatment of wounds, the firm is hoping the pocket-sized device delivers a big payoff. The portable single-use negative pressure wound therapy system consists of a disposable, one-button pump, attached to a dressing which allows for fluid to be absorbed through the dressing. Canisters are not needed and the dressing can be worn up to seven days.
 

FDA warns J & J on insulin pumps

January 17, 2012

Johnson & Johnson could face penalties for not reporting incidents where insulin pumps have failed, the Food and Drug Administration has warned.
 

Self-sanitizing keyboard uses ultraviolet light

January 04, 2012

Vioguard announced that its self-sanitizing computer keyboard has received marketing clearance from the Food and Drug Administration. The keyboard was developed to address the need for continual disinfection efforts in healthcare settings, such as skilled nursing facilities. The keyboard uses ultraviolet light to automatically cleanse its surfaces. Ultraviolet light is a proven killer of flu, MRSA, and other harmful viruses and germs, the firm notes.
 

Alexza surges after inhaled antipsychotic drug gets support

December 28, 2011

Stock prices for Alexza Pharmaceuticals Inc. recently surged by 25% to 78 cents. This came after the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee conditionally backed the drugmaker's plan to sell an inhaled antipsychotic drug. Adusave is approved for people with schizophrenia and bipolar mania. However, the panel's 9-8 vote was contingent on the company using a risk mitigation plan proposed by the FDA.
 

FDA approves Boostrix to prevent three diseases in older people

July 12, 2011

The Food and Drug Administration has approved the Boostrix vaccine for the treatment of tetanus, diphtheria and pertussis (whooping cough) in people ages 65 and older. Boostrix is the first vaccine approved to prevent all three diseases in older people. "Pertussis is a highly contagious disease and outbreaks have occurred among the elderly in nursing homes and hospitals," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research
 

FDA approves medicine for treatment of deep vein thrombosis

July 06, 2011

The Food and Drug Administration has approved Janssen Pharmaceuticals, Inc.'s Xarelto (rivaroxaban ). Xarelto is intended for the treatment of deep vein thrombosis (DVT). If all or part of a DVT breaks off, it can travel to and lodge in the lungs, and can lead to potentially life-threatening consequences.
 

FDA approves rapid MRSA/MSSA test

May 10, 2011

The U.S. Food and Drug Administration has approved a blood culture test that can determine if Staphylococcus aureus bacteria infections are methicillin resistant (MRSA) or methicillin susceptible (MSSA).
 

Senate empowers the FDA with passage of new food safety bill

December 01, 2010

The Senate voted 73 to 25 Tuesday to pass a bill that gives the Food and Drug Administration more oversight over food safety standards.
 

FDA warns: Emergency alert pendants carry potential for choking, death risks

September 24, 2009

A popular emergency alert pendant could pose a deathly choking hazard, the Food and Drug Administration cautioned consumers Tuesday.
 
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