Almost exactly one year ago, with holiday travel on my mind, I wrote about a medication that could potentially help with jet lag. Now, as …
Tag: FDA
Cancer-vaccine review highlights debate over costs and benefits of pricey treatments
UPDATE 11-17-10: An advisory panel recommended today that the drug be covered by Medicare. A final decision will be made this spring. *** 11-8-10: Last …
Comfort from FDA with one question
Here's a small sign that things are turning around at the U.S. Food and Drug Administration. A few days ago, my blog entry about the …
FDA walks line between innovation and safety
"We're scared. We don't know what to expect." That's what one medical device company executive told me about the U.S. Food and Drug Administration's plans …
Prescription drugs and direct-to-consumer advertising
UPDATE 08-06-10: Part two of Ishmeal Bradley's series was published today on Clinical Correlations. In this segment, he discusses how direct-to-consumer advertising shapes physician prescribing …
Bioethicist "spits" on personalized genomics
Arthur Kaplan, PhD, director of the Center for Bioethics at the University of Pennsylvania, has authored an opinion piece on MSNBC pooh-poohing personalized genomic testing …
FDA to consider regulating genetic testing next week
Today there are more than 100 companies offering some form of genetic analysis and many others that are in the process of developing similar tests. …
Brainstorming on how FDA can promote device innovation
The United States is the world leader in creating lifesaving medical devices, but can we get even better at it? The U.S. Food and Drug …
FDA on Mylotarg: Too fast or too slow?
The U.S. Food and Drug Administration issued a release today about a cancer drug being withdrawn from the market that underscores the agency's troubles with …
FDA approves vaccine treatment for prostate cancer
Earlier in the week, I wrote about a cancer vaccine treatment that Stanford pathologist Edgar Engleman, MD, developed in the early 90s. As expected, the …
Vaccine treatment may soon be used for prostate cancer
Later this week, the FDA is expected to approve a novel vaccine treatment for prostate cancer. As reported by ABC today, the vaccine, which works …
FDA launches medical device transparency site
The Food and Drug Administration (FDA) recently launched a Center for Devices and Radiological Health (CDRH) Transparency Web site as part of its initiative to …
FDA warns spas about fat-busting claims
I'm getting married in a year and, like any smart groom, I know that I can't let myself go until after the wedding. So I've …
Stanford researcher cautions against widespread use of statins
Last year, I recorded a 1:2:1 podcast with Mark Hlatky, MD, a Stanford professor of health research and policy, about the preventive use of cholesterol-lowering …
Improving medical device regulation in the United States
In a recent New England Journal of Medicine article, Stanford health economist Alan Garber, MD, PhD, examines the shortcomings of the Food and Drug Administration …
Positive results in deep-brain stimulation trial for epilepsy
Deep-brain stimulation - implantation and activation of a device that sends electronic pulses to targeted brain regions - has already proved helpful for Parkinson's Disease. …