FDA

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White House Proposes New Import Safety Rules

Tougher rules, stiffer enforcement

(Newser) - The White House is set to roll out stiffer safety regulations governing imports today, reports the Wall Street Journal. The proposals, prompted by the wave of recalls this year, represent a move toward what the Journal calls "a prevention-based regulatory system that targets the riskiest products." The FDA...

Sales of Heart-Surgery Drug Halted
Sales of Heart-Surgery Drug Halted
Nov 5, 2007 9:35 PM CST

Sales of Heart-Surgery Drug Halted

Anti-bleeding med yanked after study shows higher death risk

(Newser) - Bayer Pharmaceuticals will suspend the sale of Trasylol, a drug used to control bleeding during heart bypass surgery, after a clinical study found that the drug puts patients at increased risk of death, the Washington Post reports. The FDA said sales of the drug would be halted at least until...

New Blood Thinner Tops Plavix in Trials

But prasugrel also adds risk of bleeding to death

(Newser) - An experimental new blood-thinner looks like real competition for top-selling anti-clotting drug Plavix, after proving more effective at preventing heart attacks, strokes, and heart-related death in a recent trial, the AP reports. But “there is a price to pay” for increased effectiveness, wrote one doctor—the new drug caused...

Budget Batters FDA Oversight of Foreign Drugs

Commissioner to testify before Congress today

(Newser) - The federal Food and Drug Administration's spotty record inspecting foreign drug manufacturers will be even worse next year as its budget drops just as developing countries are flooding the market with new medications, reports the Washington Post. Foreign drug plants are inspected only once every eight to 12 years because...

Chinese Drugs Go Unchecked
Chinese Drugs Go Unchecked
Oct 31, 2007 12:54 PM CDT

Chinese Drugs Go Unchecked

Loophole allows pharma-producing chemical companies to bypass regulation

(Newser) - China’s massive prescription drug industry has an equally massive flaw: pharmaceuticals made by chemical companies are not held to regulatory standards. Of nearly 500 Chinese companies at a recent drug trade show, 82 were unregulated and uncertified, the New York Times discovered. “This is definitely against the law,...

FDA Advisers Reject Cold Meds for Kids

Popular remedies don't work and aren't safe for for children under 6

(Newser) - Over-the-counter cold medicines are dangerous for children under 6 and should not be used, a panel of health advisers reported to the FDA today. Many popular medicines, including Dimetapp, Triaminic, and Pediacare, have never been sufficiently tested on children under 12, the committee concluded. “The data that we have...

Viagra Linked to Hearing Loss
Viagra Linked to Hearing Loss
Oct 19, 2007 8:20 AM CDT

Viagra Linked to Hearing Loss

FDA puts warning label on popular sex drugs

(Newser) - Add hearing loss to the list of potential side effects of Viagra and other drugs to treat sexual dysfunction. The federal Food and Drug Administration will add a warning about the risk to the labels of Viagra, Cialis, Levitra and a hypertension drug, Revatio, which contains the same ingredient as...

Overdose Fears Prompt Recall of Infant Drugs

Danger found in cough and cold medicines for kids under 2

(Newser) - Several drugmakers have recalled over-the-counter cough and cold products for infants over concerns about fatal overdoses, Reuters reports. Johnson & Johnson Wyeth and Novartis are among those recalling medicines; CVS said it will remove the products and generic equivalents. One professor took the criticism one step further: “There are...

FDA Promises More Generics
FDA Promises More Generics  
Oct 5, 2007 9:19 AM CDT

FDA Promises More Generics

Commits to reviewing applications faster

(Newser) - The FDA approved about a third more generic drugs in fiscal 2007 than the year prior, and pledged yesterday to speed its review process to accommodate yet more. Sales of generics, which average about one-third the cost of their brand-name counterparts, are up 22%—and one advocacy group says the...

FDA May Ease Rx Drug Sales
FDA May Ease Rx Drug Sales
Oct 4, 2007 5:55 AM CDT

FDA May Ease Rx Drug Sales

Agency considers 'behind-the-counter' drug sales by pharmacists

(Newser) - The federal Food and Drug Administration may allow more drugs to be sold by pharmacists without a prescription if they are kept behind the counter off display shelves. The FDA  announced a hearing next month to explore the "public health benefit of drugs being available without a prescription but...

FDA May Ban Cold Medicines for Young Children

Overdoses are common, and death possible in kids under 6

(Newser) - FDA experts have concluded that over-the-counter cough and cold medicines are not safe  for very young children, and they're urging the agency to ban them. In a safety review released yesterday, they conclude that the medicines are not proven effective in children under 6 and have been implicated in more...

Lab Rats 'Treated Better Than Humans'

FDA slammed for inadequate oversight of clinical trials

(Newser) - Animals used in medical research have more rights and protections than humans who participate in clinical trials, according to a federal investigation. The Food and Drug Administration has only 200 inspectors to monitor 350,000 clinical trials and most of their field reports are ignored, reports the New York Times....

Senate Passes FDA Drug Safety Bill

Measure would give agency more power over prescription drugs

(Newser) - The Senate moved the Food and Drug Administration drug-safety bill one step closer to law yesterday, passing it unanimously and sending it to President Bush, who is expected to sign it. The measure would grant the FDA more control over warnings on prescription drugs, and would allow the organization to...

Antidepressant Warning Preceded Youth Suicide Surge

Unintended effect unfolded as use fell

(Newser) - Four years after the FDA and other agencies sparked a drop in antidepressant use by labeling the meds a suicide risk for young people, a new study shows the results were exactly the opposite of what regulators intended. From 2003 to 2004, the suicide rate among people under 19 rose...

FDA Eyes New Sunscreen Labels
FDA Eyes New Sunscreen Labels
Aug 23, 2007 2:58 PM CDT

FDA Eyes New Sunscreen Labels

Labels would include cancer warning and a rating system

(Newser) - The FDA is proposing new regulations for sunscreen labels, added a rating for protection from skin cancer as well as sunburn. Current sunscreen ratings for SPF—sun protection factor—cover only ultraviolet "B" rays, which cause sunburn. The FDA wants to start testing and rating products for ultraviolet "...

Dark Chocolate Gets Sweeter Every Day

Milk chocolate's healthier sibling grows more popular than ever

(Newser) - Overall chocolate sales are down, but Americans are increasingly indulging their sweet tooth with dark chocolate. The bitter, coffee-flavored treat is on the rise: Last year, dark chocolate sales surged 15% while sales of more popular milk chocolate dipped 5.5%. And boosted by claims of health benefits, dark chocolate...

Wal-Mart Owns Up to Melamine in Dog Treats

Company quietly pulled products as it waited for further testing

(Newser) - Two Chinese brands of dog treats sold at Wal-Mart contain a toxic chemical, the discount giant confirms. Customer complaints about the products prompted the company to quietly pull them from its shelves last month as it waited for further tests. The results confirmed the presence of melamine, the chemical at...

FDA Panel Votes to Keep Avandia on Shelves

Controversial diabetes drug still faces heart-attack link

(Newser) - An FDA panel said today that GlaxoSmithKline's diabetes drug Avandia should remain in drugstores, despite earlier evidence the pill ups heart failure risks. Glaxo has defended its drug, countering that the risks associated with the popular Avandia are the same as those of other diabetes drugs.

Dow Sinks Further on Credit Jitters
Dow Sinks Further on Credit Jitters
Jul 27, 2007 4:10 PM CDT

Dow Sinks Further on Credit Jitters

GDP report, earnings, can't stave off 208.10 point slide

(Newser) - Stocks tumbled more than 200 points for the second day in a row, on fears that small-cap securities might be especially hard hit by a possible collapse in certain financial services. The Dow was down 208.10 to 13265.47, despite a report that the GDP grew faster this quarter...

FDA to Regulate Cigarettes
FDA to Regulate Cigarettes
Jul 26, 2007 7:15 AM CDT

FDA to Regulate Cigarettes

Congress set to pass law to give feds power over toxic ingredients

(Newser) - Congress is set to pass a law today that will give the federal FDA the same power over tobacco it has over drugs and medical devices. Identical bills in both houses, hailed by the American Lung Association as a "win for public health," would allow the government to...

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