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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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The Food and Drug Administration requested Thursday that the drugmaker Endo Pharmaceuticals stop selling Opana ER — its extended-release version of Opana.

The FDA says the move marks the first time the agency has taken steps to remove an opioid from the market because of "public health consequences of abuse."

With the approval this month of two drugs to treat hepatitis C in children, these often overlooked victims of the opioid epidemic now have a better chance at a cure. Kids may actually have an easier time than adults getting approved for the treatment, according to some health policy specialists.

Patients and their advocates are getting an ever-larger voice in how medical research is carried out. They participate in the design of experiments and have a greater say in what outcomes they care about most — and it's not always simply living longer.

Sharon Terry has lived through a couple of decades during which patients went from being complete outsiders to participants. She worries now that they risk being co-opted by the medical research juggernaut.

So, you're looking for a quick grab-and-go snack, and there's a row of energy bars at the checkout counter. Are they a healthy option?

Consumers don't need to use antibacterial soaps, and some of them may even be dangerous, the Food and Drug Administration says.

On Friday, the FDA issued a rule banning the use of triclosan, triclocarban and 17 other chemicals in hand and body washes. which are marketed as being more effective than simple soap.

The Food and Drug Administration is recommending that blood banks screen all blood donations in the U.S. for the Zika virus.

It's a major expansion from a Feb. 16 advisory that limited such screening to areas with active Zika virus transmission.

In a statement released Friday, the FDA says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.

Alexandre Carvalho (Oxitec)

The U.S. Food and Drug Administration has approved a field trial to release genetically modified mosquitoes in the Florida Keys.

FDA May Lift Restrictions On Gay Blood Donations

Jul 28, 2016

The U.S. Food and Drug Administration may be lifting regulations on blood donations from gay men. The move comes after pressure from activists in the wake of a mass shooting at an Orlando gay club and blood shortages that followed.

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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.

Amid a raging opioid epidemic, many doctors and families in the U.S. have been pleading for better treatment alternatives. One option now under consideration by the Food and Drug Administration is a system of implanted rods that offer controlled release of buprenorphine — a drug already used in other forms to treat opioid addiction.

Because it's implanted in the skin, this version of the drug can't easily be sold on the illegal market, proponents say — a key treatment advantage. The FDA is expected to decide whether to approve the device — called Probuphine — within a week.

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.

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Federal health officials are granting use of an experimental test to screen blood donations for Zika virus, an emergency step designed to protect local blood supplies from the mosquito-borne virus.

Things To Know About GMO Mosquito Test Proposed In Florida

Mar 15, 2016
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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.

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.

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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.

The Food and Drug Administration on Thursday ordered three tobacco companies to stop claiming their cigarettes are "additive-free" or "natural."

The agency said those claims could mislead smokers into thinking those cigarettes are safer than others.

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Federal authorities have suspended the license of a Miami-area blood bank for violations that include improperly notifying donors who may have been HIV-positive.

  It’s the first time the U.S. Food and Drug Administration has suspended a blood bank’s license in more than a decade.

According to a July 9 letter from the FDA, Doral, Florida-based U.S. Blood Bank did not make “reasonable attempts” to notify at least 120 donors between August 2013 and May who tested reactive for HIV and would need another test to verify the results.

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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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 A Florida oncologist was charged Thursday with giving cancer patients medications, including chemotherapy drugs, from other countries that were not approved by the federal Food and Drug Administration.

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