Tagged With fda

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John Zhang, a New York fertility doctor, wanted to push the boundaries of science and fertility by giving women at risk of passing on serious genetic conditions a chance at healthy kids through an IVF technique that uses the DNA of three people. But on Friday, regulators at the US Food and Drug Administration issued a warning: Zhang, they said, would not be allowed to move forward with the procedure. At least, not if any part of it took place in the United States.

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Let's say you've got some pretty severe arthritis pain. Your doctor prescribes you the same anti-inflammatory they have prescribed everyone else, and it works! This new drug has given you new life! But then, you start hearing disturbing news reports -- the same drug seems to be causing an increase in the rates of heart attacks and strokes. What do you do? How do you weigh the risks and the benefits?

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Asparagus might be good for you, but there is no firm evidence to suggest it can prevent cancer. And yet, the website for wellness company BioStar Organix listed it among multiple products that do just that. "Asparagus should be taken by everyone for heart, cancer prevention," the website read. It can also treat leukaemia, breast cancer, cervical cancer and help with heart arrhythmia. Not bad for a mere $US45 ($60) per bottle.

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Dietary supplements don't need to do anything, by definition. Tons of them don't. That might sound strange, since half of Americans take a vitamin or mineral supplement daily. But there are in fact, reasons to take some of them. Let's say you eat nothing but ground beef, Cheerios and Dr. Pepper every day. My nutritionist sister once saw a patient who lived this life. The human body, a machine that evolved over millions of years requiring a variety of different molecules to work best, was not optimised with a ground beef, Cheerios and Dr. Pepper-only diet in mind.

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As the end-of-the-world-as-we-know-it approached last week and the entire internet devolved into a morass of Trump headlines, the Food and Drug Administration quietly put forth proposed regulations that could drastically impact whether genetically engineered food winds up on your dinner plate in the future.

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As far as jobs enshrined at the top of America's impenetrable bureaucracy go, the head of the US Food and Drug Administration is pretty important. The chief of the FDA is responsible for setting the course of an organisation that oversees the safety and efficacy of a huge array of products that Americans use everyday, from makeup and mobile phones to food and drugs. In total, each year it oversees more than $US1 trillion ($1.3 trillion) in consumer goods.

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EpiPen, the life-saving allergy product, is now a $US1 billion ($1.3 billion) a year business for Mylan, a drug company that's currently enduring a wave of bad publicity over the extraordinary surge in US EpiPen pricing. In 2007, an EpiPen in the US cost about $US57 ($75). Today that price has skyrocketed to over $US600 ($787) -- all for about $1 worth of injectable medicine.