2012: Banner Year for New Drugs

Fueled by new cancer therapeutics, last year the annual new molecular and biological entity approval count from the U.S. Food and Drug Administration (FDA) saw its highest year since 1997. One-third of the novel products approved by the FDA’s Center for Drug Evaluation and Research (CDER) are used to treat cancers of the blood, breast, colon, prostate, skin and thyroid.

FDA approved

FDA Works Toward Regulating Medical Apps

In recent years, people are turning more and more to the Internet for health information and to “self-diagnose.” With an increasing variety of medical apps available for the iPhone, iPad, Android, and other mobile platforms, self-diagnosis has become even more accessible. Unfortunately, however, checking the boxes next to a variety of symptoms and waiting for a mobile device to spew forth a litany of potential ailments lacks the sensitivity and accuracy of a human diagnostician. Further, those who are not trained in medicine may misinterpret symptoms as erroneously relevant or erroneously irrelevant, leading to misdiagnosis.

Medical apps

Biomarker Bulletin: January 30, 2012

Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.

Biomarker Commons

FDA Efforts To Warn Smokers Temporarily Halted

In a continuing effort to educate the public on the dangers of cigarette smoking, the FDA intended to require cigarette manufacturers to post large, graphic images on packages of cigarettes. This effort has been temporarily halted by an injunction passed down from U.S. District Court Judge Richard Leon last month. The FDA’s law blog explains that Judge Leon felt the warnings were not “purely factual and noncontroversial disclosures” and that “the Government’s actual purpose is not to inform, but rather to advocate a change in consumer behavior.”

Graphic images on cigarette packs

EZ Vein Receives Quick FDA Approval

EZ Vein is designed to ease the sometimes tricky job of inserting an intravenous catheter. The noninvasive device includes an inflation cuff that goes over the arm to redirect blood from deep tissue to the target vein near the skin’s surface to make more visible and accessible to a needle.

EZ Vein

The medical device was invented by Dr. Robert Perry, a resident at Oklahoma University Medical Center. EZ Vein is so practical that federal regulators approved it in just 17 days.

According to Perry:

It was kind of a surprise. I wasn’t anticipating getting anything back until January, and I got it in October.

Source: NewsOK

(HT: Medgadget)