Food and Drug Administration

The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be dangerous to youth between 12 and 18.

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Minors won't be able to buy some cough syrup brands over the counter as a new law to curb youth substance abuse took effect.

Homeopathy has been around since the 1700s, but despite having devoted followers, there is no scientific evidence that it works. Soon, packages for homeopathic products might say just that.

Updated Dec. 1, 9:05 a.m.: The House of Representatives voted overwhelmingly on Wednesday to approve the 21st Century Cures Act, a sprawling bill to fund medical research and revamp how drugs and medical devices are approved by the Food and Drug Administration.

Al Drago / CQ Roll Call

More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday.

Researchers Seek Foolproof Method To Detect Zika Infection

Sep 19, 2016
Paula Burch-Celentano / Tulane University

Determining whether people have been infected with the Zika virus can be difficult.

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Hundreds lined up to give blood Sunday in Orlando to help the victims of the massacre at a gay nightclub, but major restrictions remain for gay men wanting to give blood themselves.

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The Food and Drug Administration removed an obstacle from of its “compassionate use” policy this month, eliminating some paperwork that physicians must do to obtain experimental drugs for some patients with immediately life-threatening illnesses.

House Bill Would Curb Regulation Of E-Cigarettes, Cigars

May 5, 2016
Ed Andrieski/Associated Press / Associated Press

Vape away.

Increasingly popular e-cigarettes and cigar varieties could be exempt from some government safety regulations if House Republicans have their way. It’s a move that alarms Democrats and public health advocates who argue that it could lead to unsafe products.

The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents.

FDA Adds Boldest Warning To Most Widely Used Painkillers

Mar 23, 2016
Sue Ogrocki/Associated Press / Associated Press Photo

Federal health regulators will add their strongest warning labels to the most widely prescribed painkillers, part of a multi-pronged government campaign to stem an epidemic of abuse and death tied to drugs like Vicodin and Percocet.

Things To Know About GMO Mosquito Test Proposed In Florida

Mar 15, 2016
Andre Penner, File / AP Photo

The spread of the Zika virus in Latin America is giving a boost to a British biotech firm's proposal to deploy a genetically modified mosquito to try to stop transmission of the disease.

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The Senate has cleared the way for approval of President Barack Obama’s nominee for commissioner of the Food and Drug Administration.

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Federal health advisers recommended approval Tuesday for an experimental implant designed to treat patients recovering from heroin and painkiller addiction.

Approvals for first-of-a-kind drugs climbed last year, pushing the annual tally of new U.S. drugs to its highest level in 19 years.

Associated Press

President Barack Obama’s nominee to lead the Food and Drug Administration defended his record Tuesday as senators pressed him about rising drug prices, slow approval times for new drugs and his ties to the pharmaceutical industry.

The nation’s biggest pharmacy benefits manager has decided to cover two new drugs that lower artery-clogging cholesterol but raise concern over prices that can top $14,000 a year.

For the first time, the Food and Drug Administration has ordered a major tobacco company to stop selling several types of cigarettes.

The FDA on Tuesday ordered the R.J. Reynolds Tobacco Company to stop selling four products: Camel Bold Crush, Vantage Tech 13 and the regular and menthol versions of Pall Mall Deep Set Recessed Filter cigarettes.

AP

Food manufacturers must be more vigilant about keeping their operations clean under new government safety rules released Thursday in the wake of deadly foodborne illness outbreaks linked to ice cream, caramel apples, cantaloupes and peanuts.

Women In Combat Zones Can Face Difficulty Getting Some Contraceptives

Aug 11, 2015
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Next year, the military will officially lift restrictions on women in combat, the end of a process that may open up as many as 245,000 jobs that have been off limits to women. But women who deploy overseas may continue to face obstacles in another area that can have a critical impact on their military experience: contraception.

The Food and Drug Administration on Friday approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades.

The drug from Sanofi and Regeneron Pharmaceuticals Inc. offers an important new option for millions of patients at high risk of heart disease. But the drug’s sky-high price tag – $14,600 per year – is certain to escalate debate about the cost of breakthrough drugs and who should take them.

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The Obama administration is cracking down on artificial trans fats, calling them a threat to public health.

The Food and Drug Administration said Tuesday that it will require food companies to phase out the use artificial trans fats almost entirely. Consumers aren’t likely to notice much of a difference in their favorite foods, but the administration says the move will to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.

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The Food and Drug Administration has filed a court order against medical device giant Medtronic over repeated problems with its implantable drug pumps that went uncorrected for years.

Under the order, Medtronic must halt most production and distribution of its Synchromed II drug pumps, which are implanted devices used to treat patients with cancer, chronic pain and severe muscle spasms.

  "The FDA expects that all patients will be treated with safe, effective and high-quality medical devices," said Jan Welch, a director in the agency's center for medical device regulation.

While more than a dozen nursing homes in Florida have stopped prescribing antipsychotic medications to dementia patients, and the percentage of nursing home residents in Florida being prescribed the risky, mood altering drugs has fallen to 21.2 percent, doctors at nursing homes in Volusia and Flagler counties continue to prescribe the drugs at high rates, an investigation by the Daytona Beach News-Journal reveals. 

 

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Federal health officials have approved the first lower-cost copy of a biotech drug to reach the U.S. market, a long-awaited milestone that could generate billions in savings for insurers, doctors and patients.

Biotech drugs are powerful, injected medicines produced in living cells. They are typically much more expensive than traditional chemical-based drugs.

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Sarasota urologist  Ronald Wheeler says he's going to continue doing a controversial prostate-cancer treatment, even though an FDA panel recently voted against it and even though the state could punish him for it.

Because the U.S. Food and Drug Administration has not approved the French device that Wheeler uses for high-intensity focused ultrasound, called HIFU, he has been treating his patients in Mexico.

Lottie Watts / WUSF

 The U.S. Food and Drug Administration wants to add new regulations to additional tobacco products, including electronic cigarettes, pipe tobacco and cigars.

The proposed regulations are not going down well in Tampa's Ybor City, which has been rolling out cigars since 1886.

At the J.C. Newman Cigar Company, the machines hum and vibrate enough to shake the old wooden floor boards.

The controversial “yoga mat” chemical can be found in nearly 500 food products ranging from bread to stuffing and snacks, according to a list released by the Environmental Working Group.

A bill to ban the sale of e-cigarettes to minors gained legislative support this week, according to the Miami Herald.

Reps. Frank Artiles, R-Miami, and Doc Renuart, R-Ponte Vedra Beach, sponsored the House version, which won approval from its first committee. The Senate version, (SB224), passed through two committees, including Appropriations.

Several cities also have made it illegal to sell e-cigarettes to minors, the Herald reports. 

In 1994, when the Republican tide took over Congress, the Food and Drug Administration lost the power to regulate dietary supplements. After the Dietary Supplement Health and Education Act passed, FDA could no longer require companies to prove their products were safe and effective; it has to wait to investigate complaints of dangerous products after they have harmed consumers.

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