June 28, 2013 |
Is it hot in here, or am I just depressed? For many menopausal women, hot flashes are just depressing. And depression, which affects at least one in four women ages 40 to 59, can intensify the misery of hot flashes, as well. No surprise, then, that a pharmaceutical company came up with the idea to market an antidepressant for treatment of vasomotor symptoms, a.k.a. hot flashes. And on Friday, bucking the recommendation of its advisory committee on reproductive health drugs, the Food & Drug Administration approved the idea.
December 15, 2013 |
Cutting-edge companies often walk a tightrope between regulators trying to keep their technologies under control and marketers trying to push them out to consumers as fast as possible. That's where a Silicon Valley company named 23andMe is today. The Mountain View, Calif., firm has been hawking genetic tests for you to take at home. You spit into a receptacle and ship your saliva back to the company so it can analyze your DNA for a mere $99. Eventually you get a readout detailing your genetic susceptibility to hundreds of diseases.
April 17, 2013 |
Three years after it approved a version of the opioid analgesic OxyContin designed to discourage the painkiller's abuse, the Food and Drug Administration has effectively barred the original form of the drug from ever reaching the legal U.S. market. The agency says it will approve no new applications from generic drug manufacturers to produce cheaper versions of OxyContin in its original form. OxyContin has been one of the nation's most abused prescription painkillers, in part because as those addicted to the potent drug built up tolerance for it, they could easily ground it up or dissolve it in water, making the potent extended-release drug easy to snort or inject for a faster, more intense high.
February 4, 2014 |
The U.S. Food and Drug Administration wants teenagers to know the “real cost” of smoking - and it's not measured in dollars. Teens who pick up a cigarette habit will wind up paying with their skin, their teeth and even their freedom, a new ad campaign warns. Other government agencies and public health groups have produced commercials about the dangers of smoking. The $54-million “Tips From Former Smokers” campaign from the Centers for Disease Control and Prevention prompted about 100,000 smokers to quit after airing for just 12 weeks, according to a 2013 study in the journal Lancet.
October 27, 2010 |
It’s no secret that the public health regulatory apparatus is stretched thin in many places, perhaps no component more so than the woefully understaffed food inspection side of the Food and Drug Administration. But say this for the FDA food police: When they do get around to looking a place over, they pay loving attention to detail. Acting on a court order sought by the FDA, U.S. marshals today seized an estimated $700,000 worth of adulterated rice and other food packaged in (unfortunately)
October 31, 2013 |
The U.S. Food and Drug Administration announced Thursday that it was stepping up efforts to prevent and address prescription drug shortages, calling the shortfalls a significant public health threat. In addition to expanding early reporting requirements for drug manufacturers, the FDA said it was launching a smartphone app that would give consumers instant information on pharmaceutical shortages. "The complex issues of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.