Food and Drug Administration

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Baby Foods Contain Toxic Heavy Metals: Report

House panel pushes FDA to set standards

(Newser) - A House Oversight Committee report says alarming levels of toxic heavy metals—including arsenic, lead, cadmium, and mercury—have been found in major-label baby food products. The heavy metals can imperil infant neurological development in infants. The subcommittee's chairman expressed frustration with federal regulators, the Washington Post reports. "...

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...

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....

Teenagers, Allergies Gave FDA Vaccine Panel Pause

Members want more research on groups largely left out of Pfizer trial

(Newser) - After months of scientific discovery and debate, and waiting, the critical moment for FDA advisory panel members arrived about 5:30pm Thursday. The question put to them for an up-or-down vote was: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh...

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...

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...

Warp Speed Boss Has Target Date for First Shot

Immunizations could begin Dec. 12, Slaoui says

(Newser) - The head of the US effort to produce a coronavirus vaccine says the first immunizations could happen on Dec. 12. A Food and Drug Administration advisory committee is set to meet Dec. 10 to discuss Pfizer Inc.'s request for an emergency use authorization for its developing COVID-19 vaccine....

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...

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...

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...

Culprit in New Salmonella Outbreak: Red Onions

Nearly 400 Americans sickened in outbreak linked to Calif. company

(Newser) - Federal health officials say an outbreak of salmonella infecting nearly 400 people in more than 30 states has been linked to red onions, and identified a California company as the likely source. The Food and Drug Administration said in a statement on Friday that Thomson International Inc. of Bakersfield, Calif....

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...

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...

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...

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