The Food and Drug Administration expanded an alert about NuVision Pharmacy of Dallas, TX, on Saturday. It said investigators found poor sterile production practices that raised concern about a lack of sterility assurance for the company's sterile drug products.
The Food and Drug Administration is moving to tighten regulations around fecal transplants, which research has shown to be an effective treatment for Clostridium difficile infection.
The Food and Drug Administration has officially approved Breo Ellipta, a much-anticipated new treatment for chronic obstructive pulmonary disease.
AstraZeneca is not entitled to more exclusivity with its antischizophrenic medication, an appeals court agreed last week. The company had claimed its drug, Seroquel, deserved another three-year extension under the Food Drug and Cosmetic Act.
The Food and Drug Administration has warned nurses, infection control staff and other caregivers to examine their medical bed mattress covers. Damaged or worn covers can allow blood and body fluids to penetrate the mattress, causing an infection risk. Mattresses can be alternating pressure, non-powered flotation mattresses, or mattresses that are part of hospital beds.
April 18, 2013
Once again the war on drugs catches frail elder patients in the crosshairs. Basically a "drive by" that shouldn't happen.
April 10, 2013
The Food and Drug Administration recently approved a new kind of type 2 diabetes drug to help better control glucose levels. Invokana prevents the kidney from reabsorbing glucose, according to the FDA.
The Food and Drug Administration recently approved a new kind of type 2 diabetes drug to help better control glucose levels. Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.
The Food and Drug Administration recently approved a new kind of type 2 diabetes drug to help better control glucose levels.
April 01, 2013
Diabetes medications Januvia and Byetta significantly increase the risk of pancreatic inflammation, according to Johns Hopkins University School of Medicine researchers.
April 01, 2013
We insomniacs know sleep is important. We've read all the studies, usually late at night when we can't sleep. We're very aware that insomnia is shortening our lives, and that our knowledge of that fact is worsening our insomnia.
Bipartisan bills introduced Wednesday in both houses of Congress propose tightening access to hydrocodone painkillers such as Vicodin.
Restricting access to hydrocodone painkillers will require a lengthy process unless Congress takes action, the Food and Drug Administration recently told lawmakers.
An advisory panel has recommended making it more difficult for long-term care residents and others to receive certain painkillers. Providers criticize the proposal, saying it could leave seniors suffering for long periods.
The Food and Drug Administration issued guidance in February for clinical trials for early-stage Alzheimer's medications.
February 20, 2013
The Food and Drug Administration should "act without delay" in tightening access to hydrocodone painkillers such as Vicodin, Congressional lawmakers urged in a recent letter.
The Food and Drug Administration is requiring manufacturers of certain sleeping pills, including the widely prescribed Ambien, to reduce current recommended dosages.
Nursing home residents could be adversely affected if proposed painkiller regulations are put in place, according to experts who spoke at a recent federal hearing. After meeting for two days last week at the Food and Drug Administration headquarters in Maryland, the panel voted 19-10 to make it tougher to access hydrocodone painkillers such as Vicodin.
January 30, 2013
Covidien will make more of its cotton-based wound care products at its Augusta, GA, locating. The move is part of an effort to prevent possible supply shortages.
Nursing home residents could be adversely affected if proposed painkiller regulations are put in place, according to experts who spoke at a recent federal hearing.
December 26, 2012
The Food and Drug Administration recently approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
November 14, 2012
Federal regulators recently approved Pfizer's new Xeljanz treatment for rheumatoid arthritis. Xeljanz was approved for patients with moderate to severe rheumatoid arthritis who did not benefit from the oral treatment methotrexate.
October 22, 2012
What if compounding pharmacies were given even a quarter of the scrutiny of long-term care inspections? If that were done, I don't believe there would be a fungus among us!
July 30, 2012
Basic infection prevention and control isn't rocket science. It is essentially following some general guidelines. Some of them pretty simplistic. Not too hard right? You would think, but ...
Companies that manufacture opioid painkillers must underwrite training and educational programs for the physicians who prescribe them, according to a new federal safety measures announced Monday.
The Food and Drug Administration approved a test Wednesday that can help physicians diagnose an infection and select the proper antibiotic much more rapidly than with existing tests.
May 29, 2012
The U.S. Senate did not approve legislation that would strengthen regulations for antipsychotic use in nursing homes, despite overwhelmingly passing a bill it was attached to on Thursday.
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.
A funding reauthorization bill that regulates the Food and Drug Administration cleared a hurdle Wednesday when a Senate committee approved it.
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.
