FDA

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US Panel: OK to Make 3-Parent Embryos —Male Ones

But there are still legal roadblocks to controversial process

(Newser) - A US National Academy of Medicine committee said Wednesday the FDA should approve clinical trials for three-parent fertilization in human embryos—with some caveats, Nature reports. In its report , the committee recommended such trials be limited to women at risk of passing along "serious mitochondrial disease" to their kids,... More »

Feds Subpoena Chipotle in Norovirus Outbreak

Looks like that food poisoning in California is leading to all sorts of problems

(Newser) - Sickened customers and employees, bad publicity, and tumbling stock prices were apparently just the beginning of Chipotle's woes. Now the restaurant chain has been slapped with a federal subpoena as part of a criminal investigation into a food poisoning outbreak in August, the AP reports. The subpoena received in... More »

FDA Lifts Ban on Gay Blood Donors

But new policy does come with restrictions

(Newser) - The nation's three-decade-old ban on blood donations from gay and bisexual men was formally lifted Monday, but major restrictions will continue to limit who can donate. The Food and Drug Administration says it is replacing the lifetime ban with a new policy barring donations from men who have had... More »

FDA Proposal: Under 18? No More Tanning Beds

Public has 90 days to comment on proposed tanning rules

(Newser) - Minors hoping to get their tan on will have to choose the kind that comes in a bottle or get their rays from the sun, according to proposed rules from the FDA. Outlined Friday, the rules would bar those under 18 from using a sunlamp or indoor tanning device, reports... More »

Scandal Is Over: Eggless Mayo Can Call Itself Mayo

FDA, Just Mayo come to an agreement

(Newser) - Just Mayo says it will get to keep its name, a decision that caps a rollercoaster year for the vegan spread that has rattled the egg industry. After months of discussions, Just Mayo's maker Hampton Creek says it worked out an agreement with the Food and Drug Administration that... More »

FDA Approves Battlefield Device for US Streets

It can plug a gunshot wound in seconds

(Newser) - A device developed by the military to save lives in the battlefield could soon be saving lives on US streets. The FDA has approved the XStat Rapid Hemostasis System, a syringe that pumps scores of tiny sponges into gunshot wounds, for general use by first responders in the US, the... More »

FDA Draws Blood in Reports on Revolutionary Biotech Firm

Startup Theranos used unapproved device, didn't field complaints: FDA

(Newser) - One year ago, Elizabeth Holmes was the golden child of the biotech world: The college dropout's company, Theranos, had developed a seemingly revolutionary way to draw blood (just one finger prick), and Holmes was named the youngest female billionaire in the US at age 30. News out of the... More »

Experts Question Safety of Birth-Control Implant

Thousands of women have complained about Essure

(Newser) - Federal health experts today questioned the maker of Essure, a popular birth control implant that many women say caused long-term pain, bleeding, and fatigue. Since 2013, the FDA has received thousands of complaints about the device, often pitched as the only non-surgical option for permanent birth control, from women and... More »

FDA Bans Sales of 4 Brands of Cigarettes

They don't meet safety review requirements

(Newser) - The Food and Drug Administration is ordering a ban on sales of four cigarette brands from RJ Reynolds because they do not meet the agency's safety review requirements. Under FDA rules, companies that launch new cigarettes must show that the products are essentially the same as older products in... More »

FDA Fights Powdered Caffeine With ... Letters

Regulators don't have legal authority to pull it, so they issue warnings

(Newser) - The Food and Drug Administration has issued warning letters to five distributors of pure powdered caffeine, saying the products put consumers at risk. Caffeine powder is usually marketed as a dietary supplement and is unregulated, unlike caffeine added to soda. Since the FDA doesn't have the legal authority to... More »

FDA Lays Down the Law on Mayonnaise

Agency says Hampton Creek brand has to contain eggs to be considered mayonnaise

(Newser) - Unilever, maker of Hellmann's mayonnaise, has been fighting for some time against a "fraudulent" brand it says is encroaching on its own sales. Unilever dropped the suit in December , but the FDA has given the company a sort of win all the same. The agency has declared that... More »

'Female Viagra' Will Be on the Market in October

Flibanserin wins the approval of the FDA

(Newser) - The FDA approved a drug called flibanserin today, and the Washington Post explains the big deal: "The little pink pill has finally arrived." That is, the FDA gave its blessing to a drug commonly referred to as the female Viagra, the first one ever designed to boost the... More »

11-Year-Olds Can Now Be Prescribed OxyContin

FDA approves drug for severe pain in kids 11 to 16

(Newser) - The FDA has approved the powerful painkiller OxyContin for a new use in children 11 to 16 who are suffering from severe, long-term pain. OxyContin is an extended-release opioid that has long been used to treat around-the-clock pain in adults. But most pain medications are not approved for use in... More »

FDA Issues Warning Over Kardashian's Instagramming

Pregnancy drug promotion 'false and misleading'

(Newser) - If Kim Kardashian is going to promote drugs, she needs to talk about their side effects as well as their benefits, the FDA has warned a pharmaceutical company. Duchesnay, maker of the morning-sickness pill Diclegis, has received a formal warning from the regulator over Facebook and Instagram posts in which... More »

America's Thalidomide Hero Is Dead

FDA's Frances Kelsey kept dangerous drug off US markets

(Newser) - Dr. Frances Oldham Kelsey, who reshaped drug regulations at the FDA and—in the words of President Kennedy—"prevented a major tragedy" of birth defects in the United States, died yesterday at the age of 101, the New York Times reports. Kelsey joined the FDA in 1960 and was... More »

Even a Little Non-Aspirin Painkiller Could Be Bad News

Risk of heart attack, stroke from NSAIDs higher than thought, even in small amounts

(Newser) - The FDA advised back in 2005 that non-aspirin nonsteroidal anti-inflammatory drugs, or NSAIDs , could up the risk of heart attack and stroke. But the agency is now boosting that warning, noting that drugs like ibuprofen (often sold under the Motrin IB brand), naproxen (Aleve), and celecoxib (Celebrex) may pose a... More »

FDA OKs Pricey New Cystic Fibrosis Drug

It'll cost patients about $250K a year

(Newser) - Federal health officials have approved a new combination drug for the most common form of cystic fibrosis. But it will come at a steep price—more than $250,000 for a year's treatment. The FDA cleared the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that... More »

FDA: Dump 'Heart Attack' Trans Fats in 3 Years

Obama gives food companies 3 years to phase out artificial trans fats

(Newser) - The Obama administration is cracking down on artificial trans fats, calling them a threat to public health. The FDA said today it will require food companies to phase out the use of artificial trans fats almost entirely. Consumers aren't likely to notice much of a difference, but the administration... More »

2 New Cholesterol Drugs May Be Game-Changers

FDA advisory panel recommends both after 2 days of hearings

(Newser) - A new batch of cholesterol-lowering drugs could bring new hope to patients who can't take popular statins, or for those who don't feel their effects. Today, an FDA advisory committee recommended approval of Amgen's Repatha, reports AP , just one day after it gave the green light to... More »

FDA: Dark Chocolate Often Not What It Seems

Unless you like milk in your dark chocolate

(Newser) - Like snacking on dark chocolate? Then we hope you're not doing it to avoid milk, because the US Food and Drug Administration tested 94 dark-chocolate bars and found milk in 61% of them, Quartz reports—including not just products with descriptions like "may contain milk" or "may... More »

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