FDA

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FDA Issues Warning on 'Toxic' Brands of Hand Sanitizer Gel

9 Mexico-made brands contain dangerous methanol, agency says

(Newser) - The FDA has warned that nine brands of hand sanitizer gel made in Mexico may be so toxic that they shouldn't even be poured down the drain. The agency has issued a warning urging the public not to use the brands, manufactured by Eskbiochem SA de CV, because they...

More Bad News for Hydroxychloroquine

FDA pulls the plug on its emergency use for COVID-19 patients

(Newser) - The FDA is out with a clear new directive on the controversial drug hydroxychloroquine: stop using it on COVID-19 patients. The agency has concluded that the anti-malarial drug and the related chloroquine "are unlikely to produce an antiviral effect," reports Politico . "Nor is it reasonable to believe...

FDA Warns About Accuracy of Popular Virus Test

Abbott Labs is pushing back but will offer more guidance to clinicians handling the tests

(Newser) - More than 235,000 coronavirus tests by Abbott Laboratories have been distributed around the US in the hopes of better categorizing who's been infected where, per Axios . But the Food and Drug Administration is now issuing a warning about those tests, saying that in some cases they may be...

America OKs New Coronavirus Test
America OKs New
Coronavirus Test
May 9, 2020 2:30 PM CDT

America OKs New Coronavirus Test

The FDA grants emergency authorization

(Newser) - US regulators have approved a new type of coronavirus test that administration officials have promoted as a key to opening up the country, the AP reports. The Food and Drug Administration on Saturday announced emergency authorization for antigen tests developed by Quidel Corp. of San Diego. The test can rapidly...

FDA Gives Emergency Approval to Sell At-Home Virus Tests

Saliva sample needs to be sent to lab for results

(Newser) - In a step forward for coronavirus tests, the FDA is allowing the sale of the nation's first saliva collection kit for use at home. The test kits have to be ordered by a physician, the New York Times reports, and will sell for about $100. The agency said Friday...

FDA Sped Up Virus Tests. Next Came Fraud

Feds will tighten scrutiny because of 'fraudulent' kits on the market

(Newser) - US regulators on Monday pulled back a decision that allowed scores of coronavirus blood tests to hit the market without first providing proof that they worked, per the AP . The Food and Drug Administration said it took the action because some sellers have made false claims about the tests and...

FDA Permits Emergency Use of Drug for COVID-19 Patients

Remdesivir might help shorten recovery time

(Newser) - US regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster. It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide. President Trump announced the news at the White House alongside Food...

Bleach Peddler: I Wrote Trump About Coronavirus 'Cure'

Mark Grenon links his letter to Trump's remarks about 'disinfectant cure'

(Newser) - "Dear Mr President, I am praying you read this letter and intervene." That's how Mark Grenon says he began a letter to President Trump proclaiming the alleged curative power of industrial bleach—right before Trump went on TV and supported disinfectant as a treatment for the coronavirus,...

2 More Dings Against Drug: an FDA Warning and a Study

Agency cautions hydroxychloroquine should only be used in very restricted settings

(Newser) - The drug once touted by President Trump as a possible "game changer" in the fight against the coronavirus has been the subject of more sobering headlines of late, and the newest one from the Food and Drug Administration doesn't help matters. Per Stat News , the FDA on Friday...

FDA Authorizes Use of Drugs Trump Championed

Scientists say there is little evidence supporting move

(Newser) - Two anti-malaria drugs that President Trump has championed have been authorized for emergency use in treating COVID-19 patients. The Food and Drug Administration issued an emergency use authorization, allowing hydroxychloroquine and chloroquine to be prescribed "when a clinical trial is not available or feasible," Politico reports. Trump has...

FDA 'Roadblock' Slows Hand Sanitizer Production

Ethanol industry want rules to be relaxed

(Newser) - As hospitals and nursing homes desperately search for hand sanitizer amid the coronavirus outbreak, federal regulators are preventing ethanol producers from providing millions of gallons of alcohol that could be transformed into the germ-killing mixture. The US Food and Drug Administration's roadblock has been frustrating the health care and...

Just One Place Shocks Autistic Students. FDA Has Stepped In

Agency bans shock devices, just the 3rd item it's ever banned

(Newser) - Federal officials on Wednesday banned electrical shock devices used to discourage aggressive, self-harming behavior in patients with mental disabilities, the AP reports. The announcement from the FDA follows years of pressure from patient groups and mental health experts who have called the treatment outdated, ineffective, and unethical. The agency first...

Jimmy John's Implicated in 5 Illness Outbreaks

Chain stops selling sprouts after FDA warning about 'adulterated' food

(Newser) - Veggies served by sandwich chain Jimmy John's have been linked to five outbreaks of E. coli and salmonella over the past seven years, affecting consumers in at least 17 states, the FDA said Tuesday. The most recent outbreak saw 22 people in Iowa sickened with E.coli in late...

Trump Promises New Strategy on Underage Vaping

Flavor may be removed from market temporarily

(Newser) - President Trump says the federal government will soon announce a new strategy to tackle underage vaping, promising, "We're going to protect our families, we’re going to protect our children, and we’re going to protect the industry." Trump was vague about what the plan would entail...

FDA Adviser Who Backed Lasik Now Opposes It

'We ignored the data on vision distortions,' expert says

(Newser) - Morris Waxler was so supportive of Lasik that he voted to approve the new eye surgery as an FDA adviser more than 20 years ago. He'd like to change his vote now. As horror stories mounted, CBS reports, "I re-examined the documentation … and I said, 'Wow...

Chains Pull Zantac After FDA Finding

FDA is looking into presence of likely carcinogen

(Newser) - Walgreens and CVS have decided to stop selling Zantac in their stores, two weeks after the FDA said it found low levels of a likely carcinogen in some of the heartburn pills. The drugstore chains said the suspension of sales, which also applies to generics, will be in effect while...

FDA Unveils Graphic Cigarette Warning Labels

Tobacco companies blocked them once and are expected to try again

(Newser) - If the Food and Drug Administration gets its way, cigarette labels in the US are about to get pretty graphic. The agency has unveiled 13 proposed warning labels that would be prominently featured on cigarette packs and in cigarette advertising if approved, reports CNBC . The labels go beyond warning of...

New Treatment for Deadliest Strain of Tuberculosis Is Massively Successful

FDA approves new 3-drug regimen

(Newser) - Good news for those with the deadliest strain of tuberculosis: It no longer has to mean a death sentence. Scientists have discovered a cure for extensively drug-resistant TB, or XDR-TB, and on Wednesday, the FDA "effectively endorsed" it, the New York Times reports. Just a small percentage of people...

Despite 10 Years of Warnings, People Still Drink Dangerous 'Cure'

FDA: Taking sodium chlorite products like Miracle Mineral Solution is basically drinking bleach

(Newser) - It's OK to believe in miracles, but drinking bleach for your ailments isn't going to lead to one. That's effectively what people are doing when they quaff a product known as Miracle Mineral Solution, and other products like it that promise a cure for autism, cancer, HIV,...

FDA: Data Manipulated Before Approval of $2.1M Drug

Novartis could face civil, criminal penalties

(Newser) - US regulators want to know why Novartis didn't disclose a problem with testing data until after the Swiss drugmaker's $2.1 million gene therapy was approved. The Food and Drug Administration said Tuesday the manipulated data involved testing in animals, not patients, and it's confident that the...

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