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Posts Tagged "FDA"

Food Matters

Serving size swaps: a research perspective

Nutrition Facts Label iStock_000015829121Small

Last month, the Food and Drug Administration proposed changing Nutrition Facts labels to make serving sizes reflect what people actually eat. Several studies support the changes, though some research suggests it’s going to take more for the public to make healthy choices. Serving sizes have always been intended to represent what people actually eat, not [...]

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Food Matters

Going gluten-free? Things to consider, part 1: Folate

Cereal Flakes

Last spring, I wrote a blog post for Scientific American’s guest blog about gluten sensitivity, a condition in which patients without celiac disease exhibit symptoms, such as bloating or fatigue, that improve with a gluten-free diet. Much controversy still exists in the media over whether non-celiacs should follow a gluten-free diet. Experts often note that [...]

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Guest Blog

How Clinical Guidelines Can Fail Both Doctors and Patients

A physician holds a stethoscope.

Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes. On the other, use of the drugs is not with potential side effects and, to many, will offer [...]

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Observations

Hey FDA, Poop Is Not a Drug

fecal transplant

Imagine if in the 1960s surgeons like Christiaan Barnard or Norman Shumway had had to use the same rules that govern the development and testing of pharmaceutical medications when they were teaching the rest of the world how to transplant hearts from the recently deceased into their patients. The idea is absurd on the face [...]

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Observations

FDA Was Right to Block 23andMe

A few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andMe to stop selling its personalized genome services kit. But a quick search of the Food and Drug Administration’s admittedly user-unfriendly website shows federal regulators have been targeting various low-cost genetic testing ventures to provide the necessary analysis that goes [...]

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Observations

Use of Avastin for Breast Cancer Nixed by FDA

fda logo

The multi-billion-dollar cancer drug Avastin is no longer an approved treatment for breast cancer treatment, per a long-anticipated announcement made Friday by the U.S. Food and Drug Administration (FDA). Avastin (bevacizumab, sold by Genentech/Roche) has been on the market since 2004 as a treatment for colon cancer. Following its lukewarm approval in 2008 for use [...]

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Observations

FDA Starts to Tackle Regulation of Health and Medical Apps

doctors medical health apps fda regulation

On-the-go doctors can already see your latest MRI or CT scan via a smart phone or tablet. But would you want them to be able to download an app that essentially turns an iPad into an EKG to determine if you are having a heart attack? Earlier this year, the U.S. Food and Drug Administration [...]

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Observations

Federal anti-smoking campaign gets graphic with images of blackened lungs and corpses

cigarette, FDA

Good news for those who think that anti-smoking warning labels aren’t prominent enough on cigarette packs and cartons (bad news for the squeamish though)—the U.S. Food and Drug Administration (FDA) will require tobacco companies to include blackened lungs, corpses, crying babies and other disturbing images on their products so that smokers fully understand the risks [...]

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Observations

Regulators consider more rigorous examination of consumer genetic tests for serious diseases

consumer genetic test

Whether you have questions about your ancestry, earwax or Alzheimer’s risk, a recent slew of genetic tests promise to give you highly personal answers. Since this summer, however, the U.S. government has been taking a closer look at establishing standards of availability—and accuracy—for direct-to-consumer (DTC) genetic tests. Some 90 percent of these tests have not [...]

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Observations

Should consumers have the right to buy any genetic test?

should genetic tests be marketed directly to consumers?

Earlier this year, consumers were close to being able to pick up a saliva-based genetic test for disease risk the next time they ran to the drug store for aspirin or sunscreen. But even though the tests are still available for purchase online, consumers, geneticists and other groups quickly started to ask questions about the [...]

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Observations

Diabetes drug investigation yields unclear decision from FDA committee

This week, a federal advisory committee of 33 experts convened to review data on the controversial type 2 diabetes drug, Avandia, and debated whether the drug should remain on the market. The meeting was prompted by recent studies suggesting that patients on the drug have an increased risk of heart attack. The U.S. Food and [...]

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Observations

Hospital error leads to CT scan radiation overdoses in 206 patients

Cedars-Sinai,CT scan,stroke,Häggström

How well do hospital medical technicians know their equipment? Not well enough in the case of some health care workers at Cedars–Sinai Medical Center in Los Angeles, where 206 x-ray computed tomography (CT) scan patients were given eight times the normal dose of radiation during brain scans over an 18-month period. The Los Angeles Times [...]

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Talking back

FDA Enlists Big Data to Track Down Pharma Fraud

Predictive analytics—lumped under the faddish banner of Big Data—is the high-profile set of techniques that tame numeric deluges to deduce that a new epidemic is starting to break or that a last-minute steal of an airfare has just popped up. The best uses for Big D may be yet to come, though. The FDA just [...]

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