Tag Archives: FDA

FDA Approves Moderna And J&J Vaccine Boosters

CNBC reports: The Food and Drug Administration Wednesday night authorized booster shots of both Johnson & Johnson and Moderna’s Covid vaccines, another critical step in distributing extra doses to tens of millions of people. At the same time, U.S. regulators also authorized “mixing and matching” vaccines, allowing Americans to get a booster shot that’s a different vaccine from the one …

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FDA To Allow Over-The-Counter Sales Of Hearing Aids

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category …

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Erickson Falls For Fake Pro-Masturbation “FDA” Flyer

Mediaite reports: On Monday night, conservative pundit Erick Erickson tweeted out a flyer purporting to be part of The Real Cost, an anti-tobacco campaign developed by the U.S. Food and Drug Administration. The top of flyer reads, “Pleasure yourself with Nicotine? Try masturbation instead!” The flyer further says, “Masturbation is a safe and healthy alternative to vaping as a solution …

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FDA To Allow “Mix And Match” For Booster Shots

The New York Times reports: The Food and Drug Administration is planning to allow Americans to receive a different Covid-19 vaccine as a booster than the one they initially received, a move that could reduce the appeal of the Johnson & Johnson vaccine and provide flexibility to doctors and other vaccinators. The government would not recommend one shot over another, …

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FDA Panel Approves Johnson & Johnson Vax Booster

CNBC reports: An influential Food and Drug Administration advisory committee on Friday said the agency should authorize boosters of Johnson & Johnson’s single-shot Covid-19 vaccine to the more than 15 million Americans who have already received the initial dose. The unanimous vote – by the agency’s Vaccines and Related Biological Products Advisory Committee – is a critical step before the …

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FDA Advisory Panel Recommends Moderna Booster

The New York Times reports: A key advisory committee to the Food and Drug Administration voted on Thursday to recommend a booster shot of the Moderna coronavirus vaccine for many of the vaccine’s recipients, at least six months after a second dose. The panel endorsed a half-dose as a third injection for people 65 and older as well as younger …

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FDA Approves E-Cigarette Products For First Time

The Washington Post reports: The Food and Drug Administration authorized a set of e-cigarette products for sale in the United States for the first time on Tuesday after it concluded that the benefit to adult cigarette smokers outweighed the risk posed to young people. The authorization of an e-cigarette device and two accompanying nicotine cartridge products, which are sold under …

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FDA Set To Approve Moderna And J&J Booster Shots

The New York Times reports: The federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the Food and Drug Administration meet on Thursday and Friday to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines. On Thursday, the F.D.A.’s advisory panel of …

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Pfizer Asks FDA To Approve Vax For Children 5 To 11

NBC News reports: Pfizer-BioNTech requested Tuesday that the Food and Drug Administration clear its Covid-19 vaccine for use in children ages 5 to 11. The FDA is expected to take at least several weeks to analyze data collected in a trial that included more than 2,000 children before it would grant emergency use authorization. While the Pfizer vaccine has been …

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CDC Backs FDA On Boosters For Those Over 65, At Risk

CNN reports: Vaccine advisers to the US Centers for Disease Control and Prevention endorsed giving booster doses of Pfizer’s Covid-19 vaccine to people 65 and older long-term care facility residents, and certain people with underlying conditions. The CDC’s Advisory Committee on Immunization Practices voted unanimously on the question: “A single Pfizer/BioNtech covid 19 vaccine booster is recommended for persons aged …

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FDA Approves Boosters For Those Over 65 Or At Risk

The New York Times reports: After weeks of internal strife at the Food and Drug Administration, the agency on Wednesday authorized people over 65 who had received Pfizer-BioNTech’s coronavirus vaccine to get a booster shot at least six months after their second injection. The F.D.A. also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming …

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FDA Advisory Panel Votes Against Boosters For All

The Washington Post reports: In an all-day FDA advisory meeting, experts resoundingly voted down Pfizer’s application for boosters for everyone 16 and older and is now debating whether to authorize an additional dose for older adults. The panelists may choose to green-light boosters for adults in older age brackets and with serious medical conditions that heighten their vulnerability to severe …

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FDA Neutral On Whether Boosters Necessary For All

The Washington Post reports: A highly-anticipated Food and Drug Administration review of evidence on whether a booster shot of the Pfizer-BioNTech coronavirus vaccine is widely necessary struck a noncommittal tone Wednesday, setting the stage for a potentially fractious debate among expert advisers to the agency this week. Pfizer and government officials have relied heavily on data from Israel in making …

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BREAKING: FDA Grants Full Approval To Pfizer Vaccine

The New York Times reports: The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, making it the first to move beyond emergency use status in the United States. The decision will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations. United Airlines recently announced that …

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FDA: “You Are Not A Horse Or Cow, Seriously, Stop It”

The Daily Beast reports: You know it’s bad when the Food and Drug Administration has to take to Twitter on a Saturday to encourage people not to take the “horse paste” drug ivermectin to fight COVID-19. “You are not a horse. You are not a cow,” the agency tweeted, not bothering to dance around the facts. “Seriously, y’all. Stop it.” …

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FDA Expected To Fully Approve Pfizer Vax On Monday

The New York Times reports: The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning. Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the …

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Boosters To Be Recommended 8 Months After 2nd Dose

NBC News reports: Federal health officials and medical experts are expected to recommend that most people in the U.S. who are eligible for Covid-19 vaccinations should get booster shots eight months after their second doses, according to two sources familiar with the discussions. The guidance, which would apply only to the two-shot Pfizer and Moderna regimens, could go into effect …

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FDA Approves Booster For Immuno-Compromised

USA Today reports: The less than 3% of Americans who are severely immuno-compromised should be able to get an extra dose of the Pfizer or Moderna COVID-19 vaccine, the federal government decided Thursday night. People who are on medications or have diseases that suppress their immune system may not have gotten adequate protection from their earlier doses of COVID-19 vaccine …

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FDA Plans Labor Day Full Approval For Pfizer Vaccine

Reuters reports: The United States Food and Drug Administration (FDA) is aiming to give full approval for the Pfizer Covid-19 vaccine by early September, the New York Times reported on Tuesday (Aug 3), citing people involved in the effort. The FDA gave emergency use authorization to the Pfizer vaccine late last year. Full approval by the FDA could push more …

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FDA Gives Pfizer Vax Priority Review For Full Approval

CNN reports: Pfizer and BioNTech said Friday that the US Food and Drug Administration has granted priority review designation to their application for full approval of their Covid-19 vaccine, and an FDA official said the decision will come “soon”. The FDA official told CNN on Friday that a decision on full approval is likely to come within two months. The …

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