The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. [Read more…]
FDA approves additional antibacterial treatment for plague
The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients. [Read more…]
FDA approves spinal cord stimulation system that treats pain without tingling sensation
Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes. [Read more…]
FDA releases draft guidance on animal drug compounding from bulk drug substances
As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.” Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option. [Read more…]
FDA proposes rule to collect antimicrobial sales and distribution data by animal species
The U.S. Food and Drug Administration proposed a rule today that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.
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The Gray Areas Of Assisted Suicide
SAN FRANCISCO — Physician-assisted suicide is illegal in all but five states. But that doesn’t mean it doesn’t happen in the rest. Sick patients sometimes ask for help in hastening their deaths, and some doctors will hint, vaguely, how to do it. [Read more…]
Facing Death But Fighting The Aid-In-Dying Movement
Stephanie Packer was 29 when she found out she has a terminal lung disease.
It’s the same age as Brittany Maynard, who last year was diagnosed with terminal brain cancer. Maynard, of northern California, opted to end her life via physician-assisted suicide in Oregon last fall. Maynard’s quest for control over the end of her life continues to galvanize the “aid-in-dying” movement nationwide, with legislation pending in California and a dozen other states. [Read more…]
Federal advisory committees are critical to the legislative process – and the public should be more involved
In mid-April, President Obama signed a law that fixed Medicare’s controversial and unpredictable payment formula for physicians. Called the “Doc Fix,” the law puts in place a more stable payment schedule that provides small increases for doctors for the next five years. Notably, physicians who participate in alternative payment models – models that reward quality, value and accountability instead of quantity – will receive a 5% annual bonus between 2019 and 2024. [Read more…]
Feds Say That In Screening Colonoscopies, Anesthesia Comes With No Charge
Earlier this week the federal government clarified that insurers can’t charge people for anesthesia administered during a free colonoscopy to screen for colorectal cancer. That’s good news for consumers, some of whom have been charged hundreds of dollars for anesthesia after undergoing what they thought would be a free test. But the government guidance leaves important questions unanswered. [Read more…]
The Healthy Debate About Mental Health
May 2013 may be remembered as a watershed (or maybe a Waterloo) in the history of psychiatry. Two major events have set the stage for a fundamental debate about how we should think about the nature of mental illness.
The American Psychiatric Association (APA) is about to publish the fifth edition of its diagnostic system of classification: DSM-5. And, three weeks before the publication, Thomas Insel, director of the National Institute of Mental Health (NIMH), announced that his agency will be moving away from funding studies based on the DSM categories. [Read more…]