Tag: food and drug administration

The FDA to Regulate Apps

If you have a pulse and are familiar with Apple’s iPhone, you’ve heard the slogan “there’s an app for that.” With the number of apps exceeding 350,000 for just the iPhone and iPod Touch iOS platform, and ten of thousands of apps for the Android, BlackBerry and other smartphones, there are countless medical apps available. And just like Apple’s well known modern slogan, there is also another phase which is much older, scientia potentia est or “knowledge is power” – this is the phase that worries the Food and Drug Administration (FDA). The FDA is now proposing guidelines to regulate a small number of medical apps and oversee those that they deem could be dangerous to the general public if the information presented is wrong. All of these apps are medical related and will only be regulated if the information presented could put an individual at risk if the apps does not work as intended.

The policy advisor to the FDA, Bakul Patel, states that some of the apps have a simple goal of helping consumers manage their own health and wellness, for example the National Institutes of Health’s LactMed app, which gives nursing mothers information about the effects of medicines on breast milk and nursing infants. While there are other apps help health care providers improve and facilitate patient care – the Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Continue reading The FDA to Regulate Apps

Are Energy Drinks Dangerous to One’s Health?

Feeling sluggish? A hit of Red Bull or similar energy drink will solve that, because as the ad campaign says, “it gives you wings.” Of course with as much caffeine as a cup of coffee and a quarter cup of sugar it is no doubt that a can of an energy drink will get the motors running.

According a recent study from the University of Texas Medical School at Houston the drinks can be a problem, and mixed with alcohol can be dangerous or even lethal. Well the sound of a cup of coffee with sugar isn’t a big deal, how many people drink cup after cup after cup of coffee? That’s part of the equation; the other apart is what the combination of herbs and vitamins can do, especially when mixed with concentrations of caffeine. Probably something like a racing heart, hypertension and anxiety, as well as headaches and even problems sleeping. One thing the energy drinks don’t do is actually give you wings. Continue reading Are Energy Drinks Dangerous to One’s Health?

FDA Removes Implant After Admitting It Hastily Approved It

For anyone who has received treatment for their injuries from exercising or sports, you know the importance of getting proper medical care and you expect that whatever the doctors need to put inside you is safe. But what if a procedure done to you or device put inside you wasn’t properly approved by the medical community?

It looks like that is the case with an implant device called the Menaflex Collagen Scaffold from ReGen Biologics Inc. According to the Los Angeles Times, the device—used to repair and reinforce tissue that cushions and helps lubricate bones in the joint of the knee—had received fast-track approval in 2008 despite the objections of Food and Drug Administration scientists, who wanted more testing done on it. Continue reading FDA Removes Implant After Admitting It Hastily Approved It