FDA

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Pet Foods Recalled After Deaths of 28 Dogs

Tests find toxin in some Sportmix lots

(Newser) - Federal regulators are warning pet owners that some pet foods sold under the Sportmix label "may contain potentially fatal levels of aflatoxin." At least 28 dogs died after eating dog food that was found to have high levels of the toxin, NBC reports. Another eight became ill. Midwest...

FDA Has French Dressing, Cherry Pie in Crosshairs

The agency wants to deregulate some American pantry staples

(Newser) - The Food and Drug Administration has made the stripping away of rules that have governed the content and quality of certain foodstuffs a priority under the Trump administration, and some odd targets appear to be at the top of the list as Washington prepares to transition to a President Biden....

Outside Experts Endorse Moderna Vaccine

FDA is on track to approve emergency use on Friday, with distribution starting in days

(Newser) - The Food and Drug Administration plans to approve a second coronavirus vaccine for emergency use on Friday, after an outside panel of experts agreed that the benefits of Moderna's product outweigh the risks. The head of the federal vaccine distribution effort plans to ship nearly 6 million doses to...

New Test Can Provide Results in 20 Minutes

FDA approves kit that requires no prescription and connects to app

(Newser) - The first home test for COVID-19 that doesn't require a prescription will soon be on US store shelves. Regulators on Tuesday authorized the rapid coronavirus test, which can be done entirely at home. The announcement by the Food and Drug Administration represents another important—though incremental—step in efforts...

Trump Aide Threatens FDA to OK Vaccine

Agency chief Stephen Hahn told to resign if it's not done by end of the day

(Newser) - The FDA and Pfizer were scrambling Friday to announce approval of the coronavirus vaccine after a threat from the White House. President Trump's chief of staff told the agency's commissioner to resign if the vaccine isn't cleared by the end of the day, the Washington Post reports....

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

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...

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