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Keyword: fda

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  • FDA Pulls Authorization for Original Pfizer and Moderna COVID Vaccines

    04/19/2023 8:14:58 AM PDT · by bitt · 39 replies
    westernjournal.com ^ | 4/19/2023 | VICTORIA JONES
    The Food and Drug Administration pulled the emergency use authorizations for the original COVID vaccines produced by Moderna and Pfizer on Tuesday. Both vaccines were authorized for emergency use more than two years ago after they were developed under Operation Warp Speed during the Trump administration. In a news release, the FDA explained the older vaccines no longer offer full protection from new strains of the virus. The agency said it had amended the emergency use authorizations of the initial Moderna and Pfizer-BioNTech vaccines in order to “simplify the vaccination schedule for most individuals.” “This action includes authorizing the current...
  • FDA: Monovalent Pfizer and Moderna COVID-19 Vaccines Are No Longer Authorized, New Protocols Announced

    04/18/2023 5:23:00 PM PDT · by Enlightened1 · 18 replies
    GP ^ | 04/18/23 | Anthony Scott
    In a press release on Tuesday, the FDA has declared the monovalent Pfizer and Modena mRNA Covid-19 vaccines are no “longer authorized for use in the United States.”The decision was made through a recent amendment to the Emergency Use Authorizations of the Moderna and Pfizer Covid-19 bivalent vaccines.In the amendment, the FDA ruled the bivalent Moderna and Pfizer Covid-19 vaccines will be used for all doses and monovalent doses (targeted original strain) will no longer be authorized. The FDA claims the decision was made in order to simplify the vaccine process, but many people who have already received the monovalent...
  • Surprise! The COVID vaccines were never tested for safety

    04/12/2023 6:42:24 AM PDT · by george76 · 47 replies
    Steve Kirsch ^ | APR 11, 2023 | Steve Kirsch
    There were 31% higher deaths in the vax group in the "gold standard" Phase 3 clinical trials. How do we know that none of those deaths were caused by the vaccine? Because Pfizer said so. No evidence. Executive summary.. There were 31.2% higher deaths in the "gold standard" Pfizer Phase 3 clinical trials. There is only one way to know whether or not the vaccine caused any of the deaths in the 21 vaccinated patients who died: proper histopathology. Pfizer never did it and the FDA never asked for it. This was the biggest mistake in the pandemic and nobody...
  • (SC) GOP Rep. Mace joins AOC in urging FDA to "ignore" abortion pill freeze

    04/10/2023 2:19:13 PM PDT · by Perseverando · 26 replies
    Axios ^ | April 10, 2023 | Shawna Chen
    <p>Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Nancy Mace (R-S.C.) may be on the opposite ends of the spectrum when it comes to abortion rights, but on the conflicting rulings about abortion pills they agree: The Food and Drug Administration (FDA) should "ignore" a Texas federal judge's decision to halt the approval of abortion medication.</p>
  • Washington state stocks up on three-year supply of abortion pills ahead of court ruling that could ban meds across US

    04/08/2023 9:10:35 AM PDT · by Morgana · 12 replies
    Daily Mail UK ^ | April 5, 2023 | Cassidy Morrison
    The state of Washington has secured a three-year supply of abortion pills in anticipation of a nationwide ban. The Democratic-run state has received a shipment of 30,000 doses of generic mifepristone, one of two drugs used to induce an abortion at home. The move is a direct response to a pending lawsuit in Texas overseen by federal judge Matthew Kacsmaryk, who is considering whether to revoke the FDA's approval of the drugs in an unprecedented move. If he does move to revoke the approval, it would effectively end the ability of providers or pharmacists nationwide to purchase the medication and...
  • Federal Judge Blocks Dangerous Abortion Pill Nationwide, Saving Babies From Abortion

    04/08/2023 7:55:09 AM PDT · by Morgana · 18 replies
    Life News ^ | April 8, 2023 | Steven Ertelt
    A federal judge has issued a ruling that will stop the sales of abortion drugs nationwide and possibly save hundreds of thousands or even millions of babies from abortions. The abortion drug mifepristone is used for more than half of all abortions in the U.S. every year, or hundreds of thousands of unborn babies, according to the pro-abortion Guttmacher Institute. But a new lawsuit, filed by a group of doctors with the Alliance for Hippocratic Medicine, challenges the U.S. Food and Drug Administration’s approval and later expansion of the deadly drug under the Clinton, Obama and Biden administrations. Represented by...
  • Oregon's Wyden urges Biden administration to ignore Texas judge's abortion pill ruling

    04/08/2023 6:08:07 AM PDT · by Oldeconomybuyer · 18 replies
    ABC News Local ^ | April 7, 2023 | by KATU Staff
    PORTLAND, Ore. — A federal judge in Texas on Friday ordered that access to a common abortion pill be put on hold across the country, and then minutes later a federal judge in Washington ordered the Food and Drug Administration to keep the drug accessible. The dueling rulings put the medication mifepristone, which has been available for more than 20 years, in limbo. Not long after the rulings, Oregon’s senior U.S. senator, Ron Wyden, a Democrat, told KATU in a telephone interview that the president and the FDA should ignore the Texas judge’s ruling. "I think there's no basis for...
  • BREAKING: Fed. Judge Suspends FDA's Approval of Abortion Medication Pill

    04/07/2023 6:24:52 PM PDT · by CFW · 11 replies
    Red State ^ | 4/7/23 | Becca Lower
    A new ruling by a U.S. district court judge in Texas has stripped the Food and Drug Administration’s (FDA) approval of the medication abortion pill, mifepristone.
  • WARNING: Arsenic, Cadmium, and Lead Found In Major Brand Name Spices!

    04/03/2023 10:27:29 AM PDT · by ransomnote · 73 replies
    wltreport.com ^ | 4/2/2023 | Noah
    [H/T ExTexasRedhead] Heads up folks!This is a major consumer products alert…Do you love to cook with spices?Of course, who doesn’t?Variety is the spice of life, and spices are the, uhhhh, spice of cooking!But what happens when you reach for the Onion Powder or the Oregano, and along with those you get a heavy dose of Arsenic?Arsenic would otherwise be known as literal “rat poison”.Or Cadmium, which is a heavy metal.Or Lead!You know how we can no longer use lead-based-paint or leaded gasoline because of how toxic it is to humans?What if the big companies had been putting it in your...
  • FDA proposes using salt substitutes in more food

    03/25/2023 9:52:17 AM PDT · by Right Wing Vegan · 45 replies
    Digital Journal ^ | 3/25/2023 | Karen Graham
    Friday’s proposed rule looks to change the FDA’s “standards of identity” (SOI) for over 20 items, ranging from cheese to cereal flour. This simply means the SOIs list ingredients that standardized foods must contain, and which ingredients are optional. Most SOIs do not currently permit the use of salt substitutes. The proposed rule uses a “horizontal” approach to updating the SOIs. This means that the proposed rule would affect multiple SOIs and apply across various foods and categories of foods. Specifically – 80 SOIs that specify salt as a required or an optional ingredient.would be amended under the FDA’s proposal....
  • Australia Senator dropping Covid Bombs… The Vaccinated are dying…

    03/24/2023 10:48:13 AM PDT · by CFW · 31 replies
    Citizen Free Press ^ | 3/23/23 | Kane
    Dr. Simon Goddek @goddeketal · 🚨JUST IN: Deception and Lies – Senator Babet's Bombshell Revelation on Covid Vaccination in Australia Senator Babet says that the Australian people were duped into believing that mRNA injections would protect them from Covid. But now, the data is showing that the vaccinated…
  • DOING FDA’S DIRTY WORK: AMAZON PULLS POPULAR SUPPLEMENT SO BIG PHARMA CAN PROFIT

    03/21/2023 4:52:13 PM PDT · by COSIllinois · 37 replies
    The High Wire ^ | March 21, 2023 | Tracy Beanz & Michelle Edwards
    Amazon—the vast global internet enterprise that single-handedly shuttered countless smaller retailers—is putting the interests of big pharma ahead of the health and well-being of its customers. In a move that surely pleases the FDA and pharmaceutical companies, Amazon decided last month to no longer sell nicotinamide mononucleotide (NMN), a molecule naturally occurring in all life forms and vital in longevity. On the cutting edge of lifespan research, Amazon’s decision to remove NMN products is unrelated to safety issues. Instead, it hinges on a recent FDA decision announcing that because NMN is under investigation by big pharma as a potential new...
  • The FDA and CDC war against Florida Surgeon General's vaccine policies

    03/12/2023 8:45:02 PM PDT · by SeekAndFind · 9 replies
    Hotair ^ | 03/12/2023 | Jazz Shaw
    Roughly halfway through his first term, Florida Governor Ron DeSantis appointed Dr. Joseph Ladapo to be the state’s Surgeon General. It should have come as no surprise that Dr. Ladapo went to work promoting health policies that were in keeping with the Governor’s own approach to handling the pandemic. These included opposition to vaccine and mask mandates and particularly how such matters should be handled when it comes to children and pediatric healthcare. This has attracted the unfavorable attention of both the FDA and the CDC. This week they sent a letter to Ladapo, warning him that his policies are...
  • Dr. Mary Bowden Rejects Texas Medical Board Compromise, Requests Public Hearing Over COVID Treatments

    03/02/2023 9:02:26 AM PST · by george76 · 18 replies
    The Texan ^ | 3/2/2023 | Holly Hansen,
    Facing anonymous complaints, Bowden could acknowledge guilt and pay a fine, but she has demanded a public hearing instead. ... A Houston doctor facing anonymous complaints over COVID-19 treatments has rejected a disciplinary compromise offer from the Texas Medical Board (TMB). Dr. Mary Talley Bowden, an Ear, Nose, and Throat specialist who studied medicine at both the University of Texas and Stanford University, says she has successfully treated more than 5,500 COVID-19 patients without a single death. She drew controversy in 2021 for promoting Ivermectin and other early treatments while publicly criticizing vaccine mandates. After receiving complaints last year, the...
  • FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern

    03/01/2023 1:02:02 AM PST · by Libloather · 10 replies
    Reuters ^ | 2/28/23
    Feb 28 (Reuters) - The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc (RETA.O) 30% on Monday when media reports on the exit surfaced. Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. **SNIP** Jefferies analyst Maury Raycroft said in a research note that while Dunn's departure may...
  • FDA Reveals Rare, Possibly Fatal Neurological Disorder Is A “Potential Risk” With New Pfizer Vaccine

    02/27/2023 9:55:48 PM PST · by bitt · 90 replies
    gateway pundit ^ | 2/27/2023 | cullen linebarger
    People around the globe have suffered serious adverse reactions resulting from COVID vaccines, especially from the Pfizer shot. Now the Food and Drug Administration (FDA) tells us another Pfizer vaccine can cause serious complications in recipients. After receiving Pfizer’s Respiratory Syncytial Virus (RSV) shot during a clinical trial, two older individuals contracted Guillain-Barré syndrome. This was enough for the FDA to flag the disease as “an important potential risk” from the RSV shot. Yet Pfizer is still seeking approval for general public use. According to the Mayo Clinic, Guillain-Barré syndrome is a rare disorder in which your body’s immune system...
  • @KanekoaTheGreat posts photos of FDA employees who now work for Pfizer, Moderna, Johnson & Johnson, as well as career moves by Fauci and an MSM reporter

    02/26/2023 11:22:21 AM PST · by ransomnote · 7 replies
    Twitter ^ | 2/26/2023 | kanekoa.substack.com @KanekoaTheGreat
    https://twitter.com/KanekoaTheGreat/status/1629896593393750016?cxt=HHwWgMDU3Z2Ux54tAAAA
  • The FDA Wants to Interfere in the Practice of Medicine

    02/25/2023 3:34:54 PM PST · by george76 · 14 replies
    WSJ Opinion ^ | Jan. 12, 2023 | Joel Zinberg
    A little-noticed provision of the omnibus spending bill could give the agency power to ban off-label use of approved therapies.. Secreted within the 2023 omnibus appropriations bill—4,155 pages, spending $1.7 trillion—is a 19-line section that could change the way medicine is practiced. Physicians routinely prescribe drugs and employ medical devices that are approved and labeled by the Food and Drug Administration for a particular use. Yet sometimes physicians discern other beneficial uses for these technologies, which they prescribe for their patients without specific official sanction. The new legislation amends the Food, Drug and Cosmetic Act, or FDCA, to give the...
  • Not just ivermectin: New FDA authority to ban off-label uses alarms doctors

    02/23/2023 8:24:13 AM PST · by Twotone · 56 replies
    Just The News ^ | February 22, 2023 | Greg Piper
    Doctors are speaking out against a new law that arguably paves the way for the FDA to prohibit treatments for purposes it hasn't expressly authorized, going far beyond highly politicized subjects such as treating COVID-19 with ivermectin. The authority to ban off-label uses was buried on page 3,542 of the 4,155-page omnibus appropriations bill signed into law at year's end, though it's specifically applied to "banned devices." The FDA requested this "very unprecedented" update after a string of court losses, Endpoints News senior editor Zachary Brennan told WBUR earlier this month, while cautioning that it's not clear whether the agency...
  • Africa Dodged Covid Bullet [semi-satire]

    02/21/2023 8:55:48 AM PST · by John Semmens · 5 replies
    Semi-News/Semi-Satire ^ | 19 Feb 2023 | John Semmens
    Even though Africa largely failed to embrace the orthodox anti-covid strategies of lockdowns, masks, social distancing, and vaccines that world health authorities were successful in foisting on so many other parts of the globe, they also avoided most of the illness and harm experienced by those who did embrace the recommended strategies. In Africa, Ivermectin is a drug in wide use for ailments common to that continent. Doctors in the US and Europe who viewed this drug as potentially useful in treating covid were harassed and censored for advocating this drug or treating patients with it. Africa's success in fending...