FDA

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Alzheimer Drug 'Debacle' Continues With Yet Another Resignation

Aaron S. Kesselheim is 3rd FDA adviser to resign after agency approves Aduhelm

(Newser) - The "debacle" over an Alzheimer's drug recently approved by the Food and Drug Administration continues, or at least that's how the commotion is being described by a third adviser to the agency who's now quit over it. Mayo Clinic neurologist Dr. David Knopman and Washington University...

FDA Solves Problem of Expiring Vaccines

Doses will be considered good for 4.5 months now, up from 3

(Newser) - State health officials have been nervous about hundreds of thousands of doses of Johnson & Johnson coronavirus vaccine scheduled to expire in June. It's not an issue anymore. The Food and Drug Administration told the company Thursday to consider the shelf life of the product to be 4½ months,...

FDA Advisers Quit Over Alzheimer's Drug: 'Sham Process'

They're not happy the agency OK'd Biogen's Aduhelm against panel's recommendation

(Newser) - The week kicked off with controversy swirling around aducanumab, the drug being marketed by Biogen as Aduhelm to treat Alzheimer's disease. The drama continues, with two members of an advisory panel to the Food and Drug Administration stepping down over the agency's decision to OK the drug against...

FDA Approves Controversial New Alzheimer's Drug

Biogen's aducanumab receives green light, despite questions about effectiveness

(Newser) - Big news in the world of Alzheimer's: The FDA on Monday approved the first new treatment in nearly 20 years, disregarding warnings from independent advisers that the drug hasn't been shown to help slow the brain-destroying disease, per the AP . The drug aducanumab is made by Biogen and...

FDA Issues Advice on Eating Cicadas

People with seafood allergies should avoid eating the insects

(Newser) - Trillions of Brood X cicadas have emerged in eastern states after 17 years underground—and while the insects are being praised as a tasty low-fat food source, the Food and Drug Administration has sounded a note of caution. "Yep! We have to say it! Don't eat cicadas if...

Psychedelic Drug Shows Great Promise for PTSD Sufferers

Therapy assisted by MDMA (aka ecstasy) could be approved by 2023

(Newser) - Ecstasy appears on track to become an FDA-approved prescription treatment if the results of the first Phase 3 trial on psychedelic-assisted therapy are any indication. As the New York Times reports, 67% of PTSD patients who were given a dose of the drug during therapy no longer qualified for a...

FDA Reverses on Abortion Pill Access During Pandemic

As they could before Trump, women don't have to go in person for mifepristone

(Newser) - Women seeking an abortion pill will not be required to visit a doctor's office or clinic during the COVID-19 pandemic, US health officials said Tuesday. It's the latest reversal in an ongoing legal battle over the medication. The FDA announced the policy change in a letter to the...

Pfizer Asks OK for Younger Recipients

FDA approval probably is a few weeks away

(Newser) - Pfizer asked the Food and Drug Administration on Friday to add recipients ages 12 to 15 to the emergency use authorization for its coronavirus vaccine. At the moment, Pfizer has permission to distribute the vaccine for anyone 16 or older. The company said last week that its trials showed its...

2 Vaccines Collided at Plant Flagged by FDA

15M doses of Johnson & Johnson's vaccine were ruined as a result

(Newser) - The plant that lost up to 15 million doses of Johnson & Johnson's one-dose vaccine had something of a history of prior FDA violations. That's according to the AP and Washington Post , which obtained a copy of the FDA investigator's report from a year ago. It found...

Expert Panel's Vote on Third Vaccine Is Unanimous

Johnson & Johnson version requires a single shot and can be kept at refrigerator temperatures

(Newser) - A panel of experts recommended Friday that the Food and Drug Administration approve emergency use of Johnson & Johnson's new coronavirus vaccine. After the panel's 22-0 advisory vote, authorization could be granted by the FDA over the weekend, the Washington Post reports, putting the first few million doses...

FDA Drops Ultra-Cold Storage Rule for Pfizer Vaccine

Allowing regular freezer temperatures should simplify distribution

(Newser) - The Food and Drug Administration made distribution of the Pfizer coronavirus vaccine easier on Thursday by decreeing it can be stored in regular freezer temperatures after all. The agency had required the vaccine be kept at minus 76 degrees Fahrenheit to minus 112 degrees, the Hill reports. That was a...

FDA Backs Adding Vaccine to Every Moderna Vial

Production line changes will take a couple of months

(Newser) - Moderna and the Food and Drug Administration have agreed on a way to get more coronavirus vaccine to its destination, and it sounds simple enough: Put more in each vial. Filling the vials closer to the brim will put 40% more in each, the New York Times reports—14 doses...

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...

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....

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...

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