FDA

The Food and Drug Administration published guidance Tuesday detailing what's required for the emergency authorization of a coronavirus vaccine after the advice to pharmaceutical companies was delayed by White House review.

President Trump announced on Sunday that the Food and Drug Administration has issued emergency use authorization to treat hospitalized COVID-19 patients with convalescent plasma from people who have recovered from the virus.

Joined by Health and Human Services Secretary Alex Azar and FDA Commissioner Stephen Hahn for what he called a "truly historic" announcement, Trump described the treatment as safe and effective.

Google Maps

We may find out later Monday if there will be large shipments of a new test for the COVID-19 virus coming to Western New York.

Kyle S. Mackie / WBFO News

U.S. Sen. Charles Schumer (D-New York) called on Western New York dollar stores to stop carrying “potentially dangerous” over-the-counter topical products like ointments and cosmetics in Cheektowaga Monday.

In a high profile opioid case, a federal judge has overturned, in part, convictions against executives at Insys Therapeutics, the maker of a liquid fentanyl painkiller called Subsys. U.S. District Court Judge Allison Burroughs in Boston ruled that prosecutors failed to prove that Insys violated the Controlled Substances Act.

The convictions for wire and mail fraud handed down in May against Insys Therapeutics founder John Kapoor and former executives Michael Gurry, Richard Simon, Sunrise Lee and Joseph Rowan, still stand.

Dollar Tree

The U.S. Food and Drug Administration has issued another warning letter to Dollar Tree stores about its over-the-counter drugs.

Healthy Babies Bright Futures

The Senate's top Democrat is calling on the Food and Drug Administration to examine a report that found dozens of baby food products contaminated with lead and other metals.

The Centers for Disease Control and Prevention intensified its warnings about the risks of vaping, as the number of patients with vaping-related illness continues to climb.

The case count has reached 1,080, the agency announced Thursday. There have been 18 deaths in 15 states, and more deaths are being investigated. All patients reported a history of vaping, and the majority reported using THC-containing products.

Purdue Pharma, the maker of OxyContin, filed for Chapter 11 bankruptcy protection Sunday night, just days after striking a settlement with more than 2,000 local governments over its alleged role in creating and sustaining the deadly opioid crisis.

Growers Express

Fresh vegetable products distributed across the nation under several brand names have been voluntarily recalled by the manufacturer.

Federal prosecutors late Tuesday charged British drugmaker Indivior with felony fraud and conspiracy for its marketing of opioid products including Suboxone. The company allegedly created a "nationwide scheme" in the U.S. designed to convince doctors and government insurance providers that Indivior's patented opioid medications are safer and less prone to abuse than cheaper generic alternatives.

U.S. regulators say several makeup products from Claire's stores tested positive for asbestos, a mineral that has been linked to deadly cancers.

The Food and Drug Administration tested makeup from Claire's and the retailer Justice, both of which market their products to young girls and teens. In a statement Tuesday, the agency reported that it found that three product samples from Claire's and one from Justice contained the substance, and it released a safety alert about the products.

Updated at 5:58 p.m. ET

A federal judge in Pennsylvania has blocked the Trump administration from implementing a rule allowing employers to decline to offer contraceptive coverage on moral or religious grounds.

U.S. District Judge Wendy Beetlestone in Philadelphia imposed a nationwide injunction Monday which has wider effect than a similar ruling issued Sunday by a federal judge in California.

National Public Radio

U.S. Sen. Kirsten Gillibrand is calling on the U.S. Food and Drug Administration to issue clear guidelines for grocery stores to notify customers about purchased products that have been recalled.

The truth about flavored e-cigarettes focus of $19M study

Sep 24, 2018
National Public Radio

What role does flavor play in e-cigarettes? How does it impact our health and our behavior? Those are a couple of the questions researchers at Roswell Park Comprehensive Cancer Center and University of Rochester Medical Center will be investigating over the next five years thanks to a $19 million federal grant.

FDA's e-cigarette crackdown hits three local retailers

Sep 13, 2018
National Public Radio

Federal officials called it a blitz — “the largest coordinated enforcement effort in the FDA’s history” in response to concerns that e-cigarette use has become an “epidemic” among youths.

FDA issues 3 consumer warnings

Aug 29, 2018
CoinRX

The U.S. Food and Drug Administration is alerting the public about several potential dangers.

Lesley McClurg / KQED

The first prescription medication extracted from the marijuana plant is poised to land on pharmacists' shelves this fall. Epidiolex, made from purified cannabidiol, or CBD, a compound found in the cannabis plant, is approved for two rare types of epilepsy. Its journey to market was driven forward by one family's quest to find a treatment for their son's epilepsy.

Lindsay France / Cornell University Photography

A group of researchers at Cornell University has developed a new, faster test to determine whether bacteria are present in beach water. The team will be field-testing their system on Lake Erie near Buffalo July 16-18.

National Public Radio

Sen. Chuck Schumer says the Food and Drug Administration should immediately ban e-cigarette flavors like candy and cookies that can appeal to young people in the wake of warnings that teens and children are increasingly using e-cigarettes.

Ted S. Warren / AP

Politics isn't always red or blue. Lately, it's all about green.

Senate Minority Leader Chuck Schumer, D-N.Y., plans to introduce legislation on Friday to decriminalize marijuana on the federal level, adding a high-profile advocate in the effort to decriminalize, legalize and normalize marijuana use in America.

National Public Radio

Nail salon drying lamps help achieve a flawless manicure finish, but they would be regulated under a bill passed by New York's state Senate.

A former pharmaceutical industry official who says drug prices are too high will now be in charge of buying more medications than anyone in the world.

Alex Azar, former president of the U.S. arm of Eli Lilly & Co., was confirmed Wednesday as the secretary of health and human services.

In that role, he'll oversee the Food and Drug Administration, which regulates prescription drugs including those produced by his former employer. He'll also oversee Medicare and Medicaid, which together spend hundreds of billions of dollars each year on prescription medications.

About 1 in 10 Americans will have some kind of medical device implanted over their lifetime — artificial hips, pace makers, stents, cataract lenses. Drugs must undergo two clinical trials before hitting the market, but fewer than half a percent of high-risk medical devices have undergone that standard.

You may have never heard of it, but two state lawmakers want to block the sale of a herbal substance called kratom to minors.

FDA warns pet owners about bone treats

Nov 29, 2017
U.S. Food and Drug Administration

Many dog owners know not to toss a turkey or chicken bone to their dog; those bones are just too brittle. But the U.S. Food and Drug Administration is warning the risk goes beyond that, especially when it comes to the “bone treats” you may see at the store.

Scott Gottlieb, the Food and Drug Administration commissioner appointed by the Trump administration, has this in common with Michelle Obama: He wants to know what's in the food he eats.

And this, it seems, includes calorie counts.

Now, the FDA has released its guidance on implementing an Obama-era rule that requires chain restaurants and other food establishments to post calories on menus or menu boards. The mandate was written into the Affordable Care Act back in 2010.

Philip Kirby says he first used heroin during a stint in a halfway house a few years ago, when he was 21 years old. He quickly formed a habit.

"You can't really dabble in it," he says.

Late last year, Kirby was driving with drugs and a syringe in his car when he got pulled over. He went to jail for a few months on a separate charge before entering a drug court program in Hamilton County, Ind., north of Indianapolis. But before Kirby started, he says the court pressured him to get a shot of a drug called Vivitrol.

Given the fact that "New of Kopi Jantan Tradisional Natural Herbs Coffee" has been marketed as a "male enhancement" product, it might be fair to assume that consumers who plucked the instant coffee off store shelves had a clear idea of its intended effects.

U.S. Food and Drug Administration

Two Toronto law firms have launched a Canada-wide class-action lawsuit against the manufacturers of implantable defibrillators that can fail with little or no warning because of potentially defective batteries.

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