FDA

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This Could Be Big Day for Vaccine Approval in US
FDA Panel Approves
Pfizer Vaccine for US
updated
Dec 10, 2020 4:51 PM CST

FDA Panel Approves Pfizer Vaccine for US

The agency is to announce its final decision in days

(Newser) - A federal government advisory panel has endorsed Pfizer's coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. The advisory group of outside experts, in...

Patient Went for MRI, Came Out With Mask-Shaped Burn

FDA warns about metals in face masks

(Newser) - Someone is walking around with a mask-shaped burn on their face, according to the FDA. In a Tuesday alert, the agency warned against wearing face masks with metal parts during MRI exams, saying a patient had been burned "from the metal in a face mask" while undergoing a neck...

Former FDA Chief Is Avoiding Indoor Dining

'There's a grim future right now ahead of us in the next six weeks,' Gottlieb warns

(Newser) - Dr. Scott Gottlieb, former FDA commissioner, says he has been going to stores "properly masked"—but he considers indoor dining too risky during the pandemic. "I will not eat indoors in a restaurant," Gottlieb told CNBC Monday when asked if he thinks restaurants are riskier than...

Obese Might Move Up in Vaccine Line
Obese Might
Move Up in
Vaccine Line
Nov 30, 2020 7:10 PM CST

Obese Might Move Up in Vaccine Line

CDC panel to meet Tuesday on setting priorities

(Newser) - A new realization of the role obesity plays in putting people at risk of a severe COVID-19 illness could affect decisions on the order in which Americans receive a vaccine. "Obesity was ignored for the longest time, and overweight was completely ignored," said a researcher at the University...

First At-Home, Rapid COVID Test Approved

Though a prescription is still required

(Newser) - US regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and deliver results in 30 minutes. The announcement by the Food and Drug Administration represents an important step in US efforts to expand testing options for COVID-19 beyond health care...

Remdesivir Wins Approval as COVID-19 Treatment

Antiviral drug has been found to shorten recovery times

(Newser) - Remdesivir on Thursday became the first fully approved treatment for COVID-19 in the US. The Food and Drug Administration had issued an emergency use authorization for the antiviral drug in May. FDA Commissioner made the announcement , CNBC reports. Remdesivir shortened recovery time for hospitalized patients; President Trump is among the...

Pfizer's Update on Vaccine Is a 'Shift in Tone'

Announcement on application for emergency authorization predicts late November at the earliest

(Newser) - Last month, President Trump hinted that a COVID-19 vaccine could be available before Election Day, but the latest news from one of the leading developers seems to make that possibility even more remote. As the Wall Street Journal reports, Pfizer CEO Albert Bourla posted an open letter Friday announcing that,...

Trump Calls Unapproved Drug a 'Cure' for His COVID

President says it was 'blessing from God' he got virus

(Newser) - Just hours before Mike Pence defended the Trump administration's response to COVID-19 at the vice presidential debate, President Trump shared a video containing a direct message from him to the public on the virus. "I think this was a blessing from God that I caught it," the...

Trump: FDA Vaccine Rules Are a 'Political Hit Job'

With 2-month observation period, pre-election authorization is unlikely

(Newser) - The Trump administration has signed off on FDA guidelines for a thorough coronavirus vaccine review, which is likely to delay authorization until after Election Day, per the Wall Street Journal . Though officials had initially blocked the guidelines, per the AP , a senior administration official tells the Journal that the White...

Bill Gates: US Pandemic Response is 'Shocking'

He also doesn't expect a vaccine before Election Day

(Newser) - Bill Gates has some bad news for President Trump, who has suggested that a coronavirus vaccine could be available by Election Day. Gates tells CNBC that he doesn't see it happening. "None of the vaccines are likely to seek approval in the US before the end of October,...

PR Shakeup Follows Plasma Exaggeration

FDA removes Emily Miller as spokeswoman after 11 days

(Newser) - Commissioner Stephen Hahn fired the Food and Drug Administration's spokeswoman on Friday, after a bungled announcement of a blood plasma treatment for COVID-19. Emily Miller had been on the job 11 days, the New York Times reports. The contract of a public relations consultant, who had urged Hahn to...

FDA Chief: I Made a Mistake on Plasma Stat

Stephen Hahn overstated effectiveness of coronavirus treatment

(Newser) - Last weekend, FDA chief Stephen Hahn stood with President Trump and extolled the use of plasma as a coronavirus treatment. Trump said convalescent plasma "has proven to reduce mortality by 35%," and Hahn, while qualifying things a bit more, echoed the point. "What that means is—and...

Trump to Announce COVID-19 'Breakthrough'

The FDA plans to approve 'convalescent plasma' treatments

(Newser) - President Trump plans to announce the FDA's approval of a COVID-19 treatment Sunday night—but whether it's big news or hot air remains open to debate, the Washington Post reports. The treatment is blood plasma from recovered COVID-19 victims. More than 70,000 patients have already received it,...

FDA: These Hand Sanitizers Have Possibly Fatal Ingredient

These products apparently contain methanol, which you don't want to absorb or ingest

(Newser) - Using hand sanitizer? Might be good to check that label. The Food and Drug Administration is adding more hand sanitizers to its list of products to avoid because they contain methanol—which is toxic when ingested or absorbed by the skin, USA Today reports. The FDA is telling Americans to...

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...

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