Where will the money go? Well, the agency says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act, FDA News reports.
The agency plans to spend fees to fund epidemiology “best practices” and data acquisition ($7 million in [...]

Actually, we just returned from the bank and the post office, but could use a good cup of coffee. So while our water is boiling (we fancy that metaphor), we thought this would be a good time to catch up with some of the stray items that were rattling around our computer while we were [...]

A new poll finds that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to a doctor or hospital, but only 35 percent were aware that they can report these side effects to the FDA and only 7 percent indicated they would inform the [...]

Last September, Congress approved a major drug safety bill requiring that all drug print ads include adverse event reporting info, such as a toll-free telephone number and an easy-to-use web site. But as Consumers Union notes, the FDA must conduct a study to be completed in March to determine whether the same info should also [...]

The quarterly publication, which debuted this afternoon, can be found on the main page of the FDA’s web site and will be sent by e-mail for free to anyone who subscribes. (Or you can click on this). Aimed at docs, the newsletter is being made available in response to a scathing Institute of Medicine report [...]

Is there a doctor in the house? The FDA received 2½ times more reports of serious health problems linked to medication in 2005 than it did in 1998, according to a study in the Archives of Internal Medicine. Reports of serious problems grew four times faster than the total number of US outpatient prescriptions, and [...]

A new study of 650 patients who were prescribed a cholesterol med found that 87 percent who experienced an adverse symptom, such as memory or nerve pain, or memory loss, spoke to their doc about a possible connection. Most of the time, patients initiated discussion of a possible link between the drug and the side [...]

As old age sets in, it’s not unusual for an elderly person to be prescribed a growing number of meds to treat a growing number of afflictions. But this remedy, however well-intentioned, can cause a problem of its own - a growing number of adverse events, serious ones that can even result in poisoning.
A report [...]