NEWS ABOUT: FDA

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25 of 26 Drug Makers Will Curb Antibiotics in Animals

FDA's voluntary plan has gained major ground

(Newser) - The FDA's first attempt to limit antibiotic use in farm animals appears to be working: All but one of the 26 drug companies asked to curb the use of antibiotics in animals to promote growth have agreed to do so, though the plan is voluntary. The plan will see... More »

First Medical Device for Migraines Is Approved

FDA gives OK to headband that delivers electrical impulses

(Newser) - Migraine sufferers will soon be able to strap on a headband and try to zap away the pain through electrical impulses. It sounds a little futuristic, but the FDA has approved just a headband from Belgium's Cefaly, reports Reuters . It's the first medical device approved for the treatment... More »

FDA: Generic Morning-After Pills Available to All

Now generic alternatives can be sold over the counter to teenagers

(Newser) - Morning-after birth control just got cheaper and easier to buy, NPR reports. After a 10-year battle, the FDA published a letter saying that generic versions of the popular Plan B One-Step can be sold to customers without proof of age. That overruled an FDA decision in July granting Teva Pharmaceuticals... More »

FDA May Allow Babies With 3 Parents

Observers cite concerns about 'designer babies'

(Newser) - An advisory panel to the FDA is investigating the merits of a technique dubbed "three-parent IVF," a method opponents worry could lead to so-called "designer babies," the Washington Post reports. The method in question aims to help mothers who carry risky DNA mutations—causing blindness or... More »

FDA Cracks Down on 'Dangerous' Acetaminophen

Agency wants prescription combo drugs to contain no more than 325mg per dose

(Newser) - The FDA is taking steps to more closely regulate acetaminophen, issuing an official warning that doses over 325mg may hurt your liver. The FDA is asking doctors to stop prescribing "combination" drugs that contain more than that amount per dose—pain medications including Percocet, Vicodin, and codeine often contain... More »

FDA Takes First Step to Curb Antibiotics in Your Meat

Critics say it's not nearly enough

(Newser) - Farmers have been loading up their animals with antibiotics for years now in order to help them grow beefy and profitable, a practice that public health advocates have long complained about. (Think "superbugs" and the rise of antibiotic-resistant infections in humans, for example.) Today, the FDA took its... More »

FDA Approves Drug for Penis Curvature

Xiaflex is a little pricey, though

(Newser) - Men suffering from serious and even painful penis curvature have a new medical option—if they can afford to pay $26,000 or more. The FDA has approved Xiaflex , a drug that targets Peyronie's disease by reducing the build-up of a protein that creates scar tissue in the penis,... More »

FDA Smacks Down Home Genetic Testing Kits

Letter tells 23andMe to stop marketing kit immediately

(Newser) - The FDA has ordered 23andMe to "immediately discontinue marketing" its genetic testing kits, saying that the company has repeatedly failed to prove the product actually works. The Google-backed company offers mail-in genetic testing, which it promises can reveal your risk for various health conditions and drug allergies. In a... More »

Princeton Students to Get Vaccine FDA Hasn't OKed

Bexsero hasn't been approved by FDA, but FDA gave CDC OK to import it

(Newser) - Princeton University has seen seven people hospitalized in the last eight months with bacterial meningitis—specifically, a strain of the disease that the vaccine commonly administered in the US doesn't fight. And now the school is taking the unusual step of offering its students a European- and Australian-approved vaccine,... More »

90 Tons of Salad Recalled

Trader Joe's affected after 26 people sickened with E. coli

(Newser) - More than 90 tons of ready-to-eat salads and sandwiches by a California catering company are being recalled after 26 people in three states were sickened by a bacterial strain of E. coli linked to its products, federal health officials said yesterday. Glass Onion Catering is recalling approximately 181,620 pounds... More »

US to Ban Trans Fats

FDA takes first step

(Newser) - The US Food and Drug Administration is announcing today that it will require the food industry to gradually phase out trans fats, saying they are a threat to people's health. The agency is not yet setting a timeline for the phase-out, but it will collect comments for two months... More »

Johnson & Johnson Will Pay $2.2B Over Kickbacks

It's the third-largest US settlement involving a drugmaker

(Newser) - Johnson & Johnson and its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal and civil allegations of promoting three prescription drugs for off-label uses not approved by the Food and Drug Administration, the Department of Justice announced today. The allegations include paying kickbacks to physicians... More »

12% of Your Spices May Be Contaminated With 'Filth'

FDA also finds that 7% of imported spices have salmonella

(Newser) - Great, the FDA has identified one more thing for people to worry about in the kitchen: spices. The most comprehensive testing yet finds that 7% of spices imported into the country are contaminated with salmonella, reports the Los Angeles Times . That's twice as high as other foods inspected by... More »

In First, FDA Wants Safety Standards for Pet Food

Move designed to prevent scares like 2007 China crisis

(Newser) - The FDA today proposed new safety standards for pet food and farm animal feed, which, if passed, would be the first of their kind the agency has ever implemented. The rules cover such basic stuff as sanitation, hazard analysis, and manufacturing practices, NBC reports. "We have been pushing feed... More »

FDA Wants Tougher Rules for Painkillers Like Vicodin

It recommends tighter restrictions for painkillers with hydrocodone

(Newser) - It will likely be tougher for people to get their hands on Vicodin and similar painkillers next year. The FDA today recommended tougher restrictions for drugs made with hydrocodone, reports Reuters . Assuming the guidelines are approved by the department of Health and Human Services, patients would get fewer refills, and... More »

FDA: Jerky Treats Still Killing Dogs

Agency asks veterinarians, owners for help in years-long outbreak

(Newser) - The FDA reached out to veterinarians and pet owners today for help in figuring out why nearly 600 dogs have died and another 3,600 have gotten sick since 2007 after eating jerky treats, reports NBC News . Most of the treats have come from China , but the agency hasn't... More »

Big Pharma Paid for Seat at FDA Advisory Table

Gave up to $25K per meeting on painkiller safety

(Newser) - Drug companies shelled out in a big way to get a seat at meetings between the FDA and an advisory panel, paying up to $25,000 per meeting, the Washington Post reports based on hundreds of emails. The panel, which was funded by the money, helped the FDA evaluate painkiller... More »

Acetaminophen Kills 150 Americans a Year: Report

And the toll doesn't have to be that high, investigative report concludes

(Newser) - The FDA has been dragging its feet when it comes to regulating acetaminophen—the active ingredient in Tylenol and many other drugs—or at least implementing safety precautions, and Americans have been dying as it does so, a new Pro Publica / This American Life investigation concludes. Over the past... More »

New Way to Get a Caffeine Jolt: Spray It On

Startup trying to sell sprayable version

(Newser) - If you like energy drinks but hate the drinking part, then Harvard undergrad Ben Yu and venture capitalist Deven Soni have a product for you. The two are trying to launch a product called "Sprayable Energy," that, you guessed it, gives you a jolt of caffeine straight through... More »

Sleep Drugs Under Gun for Doing Job Too Well

FDA is cracking down on drowsy drugs that affect drivers

(Newser) - Back in January , the FDA told drugmakers to reduce their recommended dosage for sleep aids in an effort to stop people from zonking out on their morning drive to work. Now it's cracking the whip. The agency says it will push manufacturers for more extensive driving tests, write... More »

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