FDA

Updated 11:00 p.m. ET

Chocolate cupcake, creme, mango, tutti frutti, "blue" — sugary-sounding flavors familiar to teenage e-cigarette users are facing more crackdowns from the Food and Drug Administration.

Updated at 3:45 pm ET

The Department of Health and Human Services says it is reviewing all medical research involving human fetal tissue.

A new not-for-profit drug company, called Civica Rx, is looking to help combat drug shortages and rising prices with the help of health systems and hospitals across the nation, including several in Jacksonville.

The Food and Drug Administration announced a set of major new enforcement actions Wednesday aimed at reducing the sales and marketing of electronic cigarettes to teenagers.

Saying vaping among teenagers has reached "an epidemic proportion," the agency said it was taking a "series of critical and historic" measures to curb the alarming trends.

The illnesses started appearing in late March. Here and there, across the country, people were checking themselves in to hospitals, sick from toxic E. coli bacteria. At least 200 people got sick. Five of them died.

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The condom, the pill and now, the smartphone?

Natural Cycles, a mobile fertility app, this month became the first ever digital contraceptive device to win FDA marketing approval. 

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U.S. health officials on Thursday approved a new generic version of EpiPen, the emergency allergy medication that triggered a public backlash due to its rising price tag.

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U.S. health officials are eliminating special regulations for gene therapy experiments, saying that what was once exotic science is quickly becoming an established form of medical care with no extraordinary risks.

2 New Buildings Enhance Mayo Clinic's Status As 'Destination Medical Center' in Jacksonville

Jul 26, 2018

The Mayo Clinic has been expanding its Jacksonville campus since Gianrico Farrugia became CEO in 2015.

COURTESY OF BAYER HEALTHCARE

The maker of a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators said Friday that it will stop selling the device in the U.S., the only country where it remains available.

In hospitals across the country, anesthesiologists and other doctors are facing significant shortages of injectable opioids. Drugs such as morphine, Dilaudid and fentanyl are the mainstays of intravenous pain control and are regularly used in critical care settings like surgery, intensive care units and hospital emergency departments.

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The U.S. government has stepped up seizures of drugs ordered by Americans from international sources through the mail—including cheaper, legal medications from legitimate pharmacies, Tarbell has found.

Photo: Florida Department of Law Enforcement.

Sharona HoffmanCase Western Reserve University

(THE CONVERSATION) On June 12, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans.

U.S. regulators have approved the first generic version of an under-the-tongue film for treating opioid addiction.

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Federal prosecutors in California and Florida sued on Wednesday to stop two companies from providing stem cell treatments, alleging the clinics marketed their procedures as remedies for ailments including cancer and heart disease without proof of safety and efficacy.

An online pharmacy that bills itself as Canada's largest is expected to be fined $34 million Friday for importing counterfeit cancer drugs and other unapproved pharmaceuticals into the United States, a sentence that one advocacy group called too light for such a heinous crime.

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A leading House Democrat announced his opposition Monday to a Republican bill making it easier for some terminally ill patients to try experimental drugs, clouding the measure's fate.

Last fall, the U.S. Food and Drug Administration started looking for dangerous bacteria in a few of America's most beloved fresh foods: parsley, cilantro, basil, and prepared guacamole. The very freshness of these foods carries a risk. Since they aren't normally cooked, they may harbor nasty bugs like salmonella and Listeria monocytogenes.

The chemical BPA isn't living up to its nasty reputation.

A two-year government study of rats found that even high doses of the plastic additive produced only "minimal effects," and that these effects could have occurred by chance.

The finding bolsters the Food and Drug Administration's 2014 assessment that water bottles and other products containing BPA are not making people sick.

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Some cities, counties and school districts in Florida and around the country are helping their employees buy cheap prescription drugs from Canada and overseas.

Senate Bill Would Boost Contraceptive Coverage

Jan 7, 2018

Health-insurance policies would be required to provide coverage for FDA-approved contraceptive drugs without imposing deductibles, coinsurance or co-payment requirements under a bill filed Friday by state Sen. Lauren Book, D-Plantation.

Eli Wheatley and Christian Guardino are among a growing number of patients whose lives are apparently being saved or radically improved by gene therapy.

Wheatley, 3, of Lebanon, Ky., and Guardino, 17, of Patchogue, N.Y., were both diagnosed with what were long thought to be incurable genetic disorders. In the past, Wheatley's condition would have probably killed him before his first birthday. Guardino's would have blinded him early in life.

But after receiving experimental gene therapies, both seem to be doing fine.

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The Food and Drug Administration last month sent criminal investigation agents with search warrants into nine storefronts across Central Florida that help customers order drugs from pharmacies in Canada and overseas at big discounts.

Depending on whom you ask, finding out whether your genes make you a better athlete or give you healthier skin may be as easy as swabbing your cheeks for a DNA test on your way into a football game. But others say these "wellness" tests marketed directly to consumers are modern snake oil — worthless, or even misleading.

On Monday, the Food and Drug Administration gave a boost to direct-to-consumer genetic testing when it announced plans to streamline its approval process.

A federal Food and Drug Administration advisory committee Wednesday recommended approval of a new injectable treatment for opioid addiction.

One Jacksonville addiction specialist participated in the drug trial that the panel examined data from.


Valerie Green is still waiting to be cured.

The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn't qualify yet for the Medicaid program's criteria for treatment with a new class of highly effective but pricey drugs.

The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.

FDA Moves To Rein In Drugmakers' Abuse Of Orphan Drug Law

Sep 13, 2017

The Food and Drug Administration is changing the way it approves medicines known as "orphan drugs" after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

The Food and Drug Administration on Wednesday announced what the agency calls a "historic action" — the first approval of a cell-based gene therapy in the United States.

The FDA approved Kymriah, which scientists refer to as a "living drug" because it involves using genetically modified immune cells from patients to attack their cancer.

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U.S. regulators have approved new competition for EpiPen, the emergency allergy medicine that made Mylan a poster child for pharmaceutical company greed.

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