FDA

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FDA Approves Pricey New Breast Cancer Drug

Full course of Roche's Kadcyla will cost $94K

(Newser) - The FDA has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones. The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to...

Fish Mislabeling Rampant: 87% of Snapper Isn&#39;t
Fish Mislabeling Rampant: 87% of Snapper Isn't
study says
Feb 21, 2013 7:46 AM CST

Fish Mislabeling Rampant: 87% of Snapper Isn't

A third of fish aren't labeled correctly; worst offenders are sushi joints

(Newser) - OK, it's not horse meat, but fish mislabeling is rampant across the US, a 20-state study finds . Up to a third of restaurant and grocery-store seafood is labeled incorrectly, the Washington Post reports. Looking at specific varieties, the figures get even starker: Some 94% of so-called tuna in New...

Soon, Monster Drinks Will Actually Be Drinks

Beverage company is changing its labeling

(Newser) - Thought you were consuming a drink every time you downed a Monster Beverage? Well, you weren't—but soon you will be. Monster Beverage Corp. is changing the labeling on its cans so that its energy drinks will no longer be considered dietary supplements, a move that changes the federal...

13 Ingredients FDA Should Ban
 13 Ingredients FDA Should Ban 
Jan 19, 2013 2:15 PM CST

13 Ingredients FDA Should Ban

Shape: US lags other developed nations on too many dangerous foods

(Newser) - At Shape , two nutritionists round up 13 ingredients the FDA allows in our food, even though other developed nations ban them. Their message is pretty clear: "If you see any of the following ingredients listed on the nutrition label, don't buy the product." A sampling:
  • Olestra: This
...

FDA Demands Lower Dosages on Sleeping Pills

Ambien, Zolpimist seen impairing people in the morning

(Newser) - Sleeping drugs like Ambien and Zolpimist are going to have to come with lower recommended dosages from now on, the FDA declared today, in the hopes that it will lead to fewer zonked-out people climbing into driver's seats for their morning commute. Studies show that eight hours after taking...

FDA Says New Rules Will Improve Food Safety

Agency issues two, with more on the way

(Newser) - The FDA has issued two new rules that it and food safety advocates say will make the nation's food supply much safer. They govern the handling of processed foods (like peanut butter ) and fruits and vegetables, reports USA Today , which calls this "the most sweeping overhaul of...

Here Comes &#39;Frankenfish&#39;
 Here Comes 'Frankenfish' 
Dec 21, 2012 5:45 PM CST

Here Comes 'Frankenfish'

Genetically modified salmon clears FDA hurdle, likely to be approved soon

(Newser) - Americans will likely be digging into the first meal from a genetically modified animal—a salmon—in about a year. The FDA has declared that salmon engineered by AquaBounty Technologies is safe to eat and poses no threat to the environment, reports the AP . The ruling makes it all but...

OB/GYN Group Backs Over-the-Counter Birth Control

But move is unlikely anytime soon

(Newser) - Women shouldn't need a prescription or doctor's exam to buy birth control pills, the American College of Obstetricians and Gynecologists declared yesterday, in a statement that the AP says comes as something of a surprise given that the doctors who make up the organization make a lot of...

That Drug You Want? Sorry, There's Still a Shortage

Nationwide shortfall ultimately hurts 'the little guy'

(Newser) - Why would a paramedic in Ohio not administer morphine to a woman in pain? Because it was his last vial—and he wasn't alone in making such an agonizing decision, the New York Times reports. A nationwide drug shortage is leaving health care workers without a variety of drugs,...

Pharmacy Chief in Meningitis Outbreak Takes the Fifth

Barry Cadden sheds no light on what happened

(Newser) - The co-owner and chief pharmacist of the company linked to the meningitis outbreak arrived on Capitol Hill today for a grilling armed with lawyers and an index card. And when House lawmakers asked Barry Cadden of the New England Compounding Center things like what happened or what he might say...

FDA: Ameridose Is Rife With Contamination Issues

Bugs, leaks found inside drug firm linked to outbreak

(Newser) - The FDA's monthlong inspection of Ameridose, a firm with the same founders as the pharmacy linked to a deadly meningitis outbreak, has produced a long and troubling list of contamination issues, the AP reports. Inside the company's drug-making facility, federal inspectors found leaky, cracked walls and ceilings, insects...

FDA: Drug Co. Knew About Mold, Bacteria Contamination

Months before the meningitis outbreak

(Newser) - Staffers at a pharmacy linked to the deadly meningitis outbreak documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile, according to federal health inspectors. In a preliminary report on conditions at the pharmacy, the US Food and Drug Administration said today that...

Monster Energy Drinks Killed 5 People: Reports

Company denies responsibility in death of teenage girl

(Newser) - Do Monster Energy drinks have unsafe levels of caffeine? The company's products killed five people over the past year and a sixth in 2009, according to reports submitted by doctors and companies to the FDA. Parents in Maryland have already used the reports in a lawsuit against Monster, America'...

Feds Raid Firm Linked to Meningitis Outbreak

Agents probing New England Compounding Center

(Newser) - Criminal investigators from the Food and Drug Administration have raided the Massachusetts company whose steroid medication has been linked to a deadly meningitis outbreak. An FDA spokesman says the agents' work at the New England Compounding Center is part of the investigation into the outbreak, which has killed at least...

Less-Regulated Pharmacies Take Heat in Meningitis Crisis

'Compounding pharmacies' make drugs with weaker oversight

(Newser) - The death toll in an ongoing meningitis outbreak has hit five, with 35 sick in six states, the AP reports. What's more, hundreds or thousands could be at risk across 23 states after receiving potentially tainted steroid injections, and health providers are rushing to warn them of the danger....

20% of Supplements Illegally Labeled: Feds
 20% of Supplements 
 Illegally Labeled: Feds 
NEW REPORT
Oct 3, 2012 6:43 AM CDT

20% of Supplements Illegally Labeled: Feds

Diet and immune-boosting supplements make false, dangerous claims, feds say

(Newser) - Dieters beware: A new report has found that dozens of dietary supplements out there bear labels that make false, illegal claims that could pose a major threat to consumers, the AP reports. Federal investigators purchased 127 types of supplements both online and in stores and found that 20% made unsubstantiated...

Farm Antibiotics Make Us Sick

 Farm Antibiotics
 Make Us Sick 
scientists say
Sep 9, 2012 2:56 PM CDT

Farm Antibiotics Make Us Sick

Farm lobby resists attempts to regulate drug use

(Newser) - Why are people getting sick and dying from antibiotic-resistant infections? In part because of the food we buy at the supermarket, advocates say. With the farm industry buying most of America's antibiotics, and pumping it into animals like chickens and pigs, we may be munching on germs that have...

FDA Hastily OKing Risky Drugs
 FDA Hastily OKing Risky Drugs 
experts say
Sep 5, 2012 10:50 AM CDT

FDA Hastily OKing Risky Drugs

...warn experts. But the public may be OK with that

(Newser) - The FDA's commissioner has been touting the agency's speedy approval of new medicines—but it has brought risky drugs to market, according to two drug-safety experts. Specifically, Thomas J. Moore and Curt D. Furberg found problems with cancer drug Caprelsa, multiple sclerosis drug Gilenya, and stroke prevention drug...

FDA OKs 4-in-1 HIV Pill
 FDA OKs 4-in-1 HIV Pill 
Aug 27, 2012 5:29 PM CDT

FDA OKs 4-in-1 HIV Pill

Stribild combines 2 drugs sold as Truvada with 2 new drugs

(Newser) - The FDA today gave the green light to a new anti-HIV pill that combines four medicines to combat the virus that causes AIDS. The agency approved Gilead Sciences' Stribild as a once-a-day treatment to control HIV in adults who have not previously been treated for infection. The pill contains two...

Court Strikes Down Gross-Out Cigarette Labels

Court concludes that the government can't prove graphic warnings will work

(Newser) - The government can't force cigarette makers to put disgusting imagery warning of the dangers of smoking on their packages, a federal appeals court ruled today. In a 2-1 decision, the justices upheld a lower court ruling that the labels violated free speech protections, the AP reports. They said the...

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