FDA

The US Food and Drug Administration (FDA) has approved a generic form of the drug Truvada, an antiretroviral and pre-exposure prophylaxis (PrEP) from Gilead Sciences. The approval notice was posted on the FDA's website yesterday; finer details, such as the cost associated with the generic (Emtricitabine and Tenofovir Disoproxil Fumarate tablets) is still unknown, though the price will no doubt go down. While the name-brand drug is blue in color, the generic version may arrive with a different design.

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The day some have feared and others have long awaited is finally here: the FDA’s e-cigarette regulations go into effect today, and they require retailers to, among other things, request identification from any prospective buyers who look like they may be younger than 27. The move aims to curb the ease by which minors have been able to acquire ‘vaping’ devices, and is joined by a ban on e-cigarette vending machines with the exception of facilities with access that has been restricted to adults only.

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Whole body cryotherapy is a growing trend amongst those brave enough to tackle the coldest (briefly) livable temperatures — if you’ve ever taken an ice bath, gone on a polar bear swim, or spent a few minutes running around in an ice chamber, you’ll probably be familiar with the general idea. Whole body cryotherapy is popping up at spas and wellness centers across the nation promising to help treat a whole host of ailments, including serious conditions like MS and Alzheimer’s disease. Finally, the FDA has stepped in with a word of caution.

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This week, the Food and Drug Administration announced its approval of a stomach-draining device called AspireAssist; it is designed to combat obesity via a drainage tube and port implanted in the patient’s stomach, allowing the patient to drain some of their stomach contents after they eat. When used properly, the device will drain about 30-percent of a meal's calories, according to the FDA, essentially serving as an alternative to lap band surgeries.

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On June 8, the Office of the Inspector General sent the FDA an ‘early alert’ letter advising it that an ongoing audit has found the Food and Drug Administration’s food recall program to be inadequate on a couple of levels, particularly when it comes to prodding companies to get a move with their voluntary food recalls. Now the FDA has fired back with its own statement, justifying its processes and saying that it expediting changes it already had in the pipeline.

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The FDA has released a draft guidance for companies that make connected medical devices, advising them of steps that should be taken to deal with cybersecurity risks. The guidance concerns medical devices that connect to a facility’s network, and comes at a time when an increasing number of companies — medical and otherwise — have been hit with massive data breaches.

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The FDA has approved genetically-modified salmon, making this the first time the agency has approved a GM animal for human consumption. The modified fish is “AquAdvantage salmon,” a type of Atlantic salmon that grows faster than regular non-GM salmon while consuming less food. Genetically-modified food has been the source of ample controversy, with some arguing that it is a threat to the environment, less healthy, and other alarmist claims.

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23andMe, the company that benefited greatly with some favor from Google, suffered a massive setback when the FDA stepped in and shutdown its genetic health screening service. At the time, users could pay $99 to spit in a vial and, some time later, access their genetic data parsed to include details about their personal health. Those details included things like risks for certain diseases and cancers, how they respond to different types of medication and diets, and more.

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23andMe ran into trouble with the FDA over its DNA testing, which included results of a medical nature — info about disease risks and such. It ultimately had to shut that part of its service down, but another company may take over in its place. Ancestry.com is in talks with the FDA about launching a DNA testing kit that will be used to provide possible health information about a person — details about things like one’s reaction to medication and more based on their genetic details.

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A device that sounds very strange has won FDA approval to come to market. The device is called the BrainPort V100 and it is a sensory substitution device that is designed to give the blind vision of a sort. Seeing in this case is done via an electrode that stimulates the tongue of the user. The FDA cleared Wicab, the maker of the device, to bring it to market last week.

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The FDA is clamping down on trans fat, telling food companies that they must cut one of the most unhealthy from what they sell within three years. The decision marks the culmination of a lengthy Food and Drug Administration investigation into partially hydrogenated oils (PHOs), which are currently the primary dietary source of artificial trans fat in processed foods. The conclusion is damning: PHOs are considered not "generally recognized as safe" for use in human food, the FDA decided, and so they have to go.

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You might recognize the name 23andMe as the company that sold home genetic testing kits. Back in 2013, 23andme was all but shut down by the FDA when the FDA ruled that the company could no longer sell its genetic testing kits. In a big turnaround, the FDA has now granted approval to 23andme to sell a home genetic test kit for one specific rare genetic disease.

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