September 2nd, 2010 by Iltifat Husain, M.D. in Better Health Network, Health Policy, News, Opinion
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Bradley Merrill Thompson, an attorney with expertise in the FDA approval process for medical devices, is stating that the FDA is actively monitoring app stores on various platforms. Regulating medical devices and health care-related applications falls under the FDA’s jurisdiction.
James Kendrick from JkOnTheRun spoke with Thompson, where he stated the following:
The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.
By “various app stores,” Thompson is likely referring to the App store [Apple], Palm App Catalog [Web OS], App World [BlackBerry], and the Android Marketplace [Android OS]. Read more »
*This blog post was originally published at iMedicalApps*
August 19th, 2010 by Debra Gordon in Better Health Network, Health Policy, News, Opinion, Research
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Time to get back up on my soap box.
Next month the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month.
The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing.
Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other cancers. The problem comes with breast cancer. Read more »
*This blog post was originally published at A Medical Writer's Musings on Medicine, Health Care, and the Writing Life*
August 12th, 2010 by David Kroll, Ph.D. in Better Health Network, Health Policy, Health Tips, News, Opinion, Quackery Exposed, Research
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On the heels of Scott Gavura’s superb post on dietary supplement regulation in the U.S. and Canada, I bring you one of the most egregious and obscene product cases I have seen in 15 years of teaching on botanical and non-botanical products: Miracle Mineral Solution. Please accept my apologies in advance for not having a scholarly post for you — this is just too unbelievable not to share with science-based medicine readers. Read more »
*This blog post was originally published at Science-Based Medicine*
August 5th, 2010 by RamonaBatesMD in Better Health Network, News, Research
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The FDA recently (March 2010) approved Asclera (poliocanol) injection for the treatment of small spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter).
Asclera is a detergent sclerosant and produces endothelial damage through interference with the cell’s surface lipids.and acts by damaging the cell lining of blood vessels. This causes the blood vessel to close, and it is eventually replaced by other types of tissue. Read more »
*This blog post was originally published at Suture for a Living*
July 31st, 2010 by Toni Brayer, M.D. in Better Health Network, Health Tips, Research
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The Environmental Working Group (EWG) is a non-profit focused on public health. We know that the long-term consequences of eating chemicals from pesticides used on our foods is damaging to our health.
The EWG analyzed data from the FDA and found that people who eat five fruits and vegetables a day from the “Dirty Dozen” are eating 10 pesticides a day. We want people to eat more fruits and vegetables, but NOT to ingest more chemicals. Rinsing reduces but does not eliminate pesticides. So what’s the answer? Rinse completely and buy the “Dirty Dozen” foods organic whenever possible. Read more »
*This blog post was originally published at EverythingHealth*
Bradley Merrill Thompson, an attorney with expertise in the FDA approval process for medical devices, is stating that the FDA is actively monitoring app stores on various platforms. Regulating medical devices and health care-related applications falls under the FDA’s jurisdiction.
