March 11, 2014 |
The U.S. Food and Drug Administration has approved the marketing of an electronic medical device intended to treat migraine headaches. In an announcement released Tuesday, officials said the transcutaneous electrical nerve stimulation, or TENS, device was the first ever to receive such approval. The device, which will be marketed under the name Cefaly , is manufactured by Cefaly Technology of Belgium. "Cefaly provides an alternative to medication for migraine prevention," read a prepared statement from Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health.
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)
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.
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.
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.
July 8, 2013 |
In a recent post , I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation from the manufacturer if they can show the drug was unreasonably dangerous or that its warning label didn't disclose the risks properly. But those injured by a generic medicine can't hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.