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Keyword: fda

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  • FDA approved a $250,000 Singapore work trip during government shutdown, records show

    12/15/2025 2:33:28 PM PST · by Twotone · 13 replies
    CNBC ^ | December 15, 2025 | Paige Tortorelli, Scott Zamost, Melissa Lee
    SINGAPORE — Sentosa Island boasts the luxury, five-star Ora and Michael hotels, with palm-tree-lined pools, lobbies flanked with luxury stores, and a casino that adjoins both hotels and buzzes with gamblers. The Singapore resort is also where a group of federal employees from the U.S. Food and Drug Administration were sent for a work trip in the final hours of the government shutdown. Internal FDA records obtained by CNBC show 31 agency staffers traveled to Singapore in mid-November for a conference of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or ICH — a trip...
  • FDA to put most serious warning on Covid vaccines... after major study finds shots cause deadly heart damage

    12/12/2025 9:38:18 AM PST · by Angelino97 · 38 replies
    Daily Mail ^ | December 12, 2025 | Luke Andrews
    The FDA is drawing up plans to put a 'black box' warning on Covid vaccines, the agency's most serious warning over potential side effects, reports suggest. The move was revealed to CNN by two people familiar with the matter, who spoke on condition of anonymity because they were not authorized to speak to the media. A black box warning, which appears at the top of prescribing information, is placed on drugs or vaccines to highlight major risks such as serious side effects or restrictions. Sources did not specify what the warning would contain, or whether it would apply to only...
  • Guttmacher admits mail-order abortion is cause of spike in abortion total

    12/01/2025 12:00:54 AM PST · by Morgana · 4 replies
    Live Action News ^ | November 26, 2025 | Carole Novielli
    Buried in a recent study published by researchers with the Guttmacher Institute (Planned Parenthood's former research arm and "special affiliate") is the real reason why reports indicate a huge spike in abortions since the end of Roe v. Wade in June of 2022: mail-order abortion. Key Takeaways: * The Guttmacher Institute notes that telehealth abortion with the ability to mail abortion pills to abortion seekers has contributed to the increased abortion numbers since the end of Roe v. Wade. * In 2023 and 2024, Guttmacher and #WeCount reported increased abortion numbers overall, with the abortion pill comprising about 63% of...
  • The FDA Memo That Shakes the World

    11/29/2025 6:41:14 PM PST · by metmom · 18 replies
    The Brownstone Institute ^ | November 29, 2025
    Over the last November weekend of 2025, a memo circulated throughout the Federal Food and Drug Administration that might well trigger the entire unraveling of the US vaccine program with a focus on the mandated Covid shot in particular. The author is Dr. Vinay Prasad, who was a moderate critic during the Covid but has become ferocious since his appointment as the head of the Center for Biologics Evaluation and Research of the FDA. Of this memo, ACIP member and scientist Robert Malone has written: “I am stunned, gobsmacked by his letter below. The significance and importance of this letter...
  • FDA Stayed Silent As Internal Reports About Potential Tylenol Risks Piled Up

    10/22/2025 4:03:25 PM PDT · by CFW · 9 replies
    Daily Caller ^ | 10/21/25 | Emily Kopp
    The Food and Drug Administration (FDA) defied the advice of its own drug safety experts to warn pregnant women about Tylenol for nearly a decade, internal reports and presentations obtained by the Daily Caller News Foundation reveal. FDA rank-and-file scientists repeatedly recommended the agency release information about Tylenol in pregnancy across three scientific reviews conducted in 2016, 2019, 2022 and two memos, one from the FDA’s maternal health division in 2016 and one from the FDA’s urological health division in 2017. The scientific literature posits many plausible drivers of autism, the most well-established of which are genetic, and the FDA...
  • Republicans Demand Answers From FDA on Approval of Generic Abortion Pill

    10/16/2025 4:01:52 PM PDT · by Morgana · 1 replies
    Life News ^ | October 16, 2025 | Anna Callahan
    On the heels of last week’s letter from 51 U.S. senators to the Food and Drug Administration and Department of Health and Human Services, HELP Committee Chairman Bill Cassidy sent an oversight letter today demanding answers from Secretary Robert F. Kennedy and Commissioner Marty Makary. Lawmakers are turning up the pressure after the FDA approved a new generic abortion drug in the wake of the Biden administration’s rollback of commonsense safeguards that required in-person doctor visits. The Biden FDA’s mail-order abortion policy, which is inexplicably still in effect, recklessly endangers women and unborn children while undermining state pro-life laws. All...
  • Republicans Want FDA Staff Fired for Approving Generic Abortion Pill

    10/15/2025 8:32:17 PM PDT · by Morgana · 8 replies
    Life News ^ | October 14, 2025 | Steven Ertelt
    House conservatives and a coalition of 51 Republican senators are demanding the firing of top Food and Drug Administration officials who approved a new generic version of the abortion drug mifepristone. The Republicans say the decision endangers women and undermines state laws protecting unborn children. The push escalated after the FDA greenlit the generic on October 1 from Evita Solutions LLC, the third U.S. company authorized to produce the dangerous abortion drug, which now account for 63% of all abortions that kill babies. Critics, including pro-life advocates and GOP lawmakers, argue the approval floods the market with a dangerous chemical...
  • FDA Approves New Generic Version of the Abortion Pill Mifepristone

    10/02/2025 5:41:00 PM PDT · by Kevin C · 12 replies
    Wall Street Journal ^ | 10/2/2025 | Jennifer Calfas
    The Food and Drug Administration approved a new generic version of a pill used to terminate pregnancies, a decision that comes as the Department of Health and Human Services reviews the drug’s safety. The FDA authorized a generic form of mifepristone, a 200-milligram oral tablet, on Tuesday from Evita Solutions, according to a letter posted on the agency’s website. Medication abortion is the most common form of abortion in the U.S. and has faced heightened scrutiny from antiabortion groups and lawmakers who have sought to limit its use.
  • The story blowing up around Oprah and Gwyneth-endorsed ‘The Tell’ is more eye-opening than the book itself

    09/27/2025 11:21:07 AM PDT · by nickcarraway · 34 replies
    New York Post ^ | Sep. 27, 2025 | Kirsten Fleming
    If Reese Witherspoon, Oprah Winfrey, Drew Barrymore and Gwyneth Paltrow are peddling a memoir from their billionaire investor pal, who has a mind-blowing tale of self-actualization — maybe just maybe, there’s a little more to the story. We learned just how much more this week, in a blockbuster New York Times piece that dug into the narrative behind Amy Griffin’s bestselling memoir, “The Tell.” And the article is far more compelling than the book itself. SNIP However, her memories were recovered during therapy sessions while under the influence of the drug MDMA — a practice that is illegal and was...
  • FDA: Some imported cookware may leach lead into food

    09/15/2025 7:04:49 PM PDT · by fluorescence · 19 replies
    NewsNation ^ | Sep 12, 2025 | Michael Ramsey
    Certain brands of imported cookware are likely to leach “significant levels” of lead into food, the U.S. Food & Drug Administration said in a consumer warning Friday. Officials tested a number of cookware products made from aluminum, brass and aluminum alloys known as “Hindalium” and “Indalium” and determined that they may release lead into food during the cooking process, the FDA said. No level of lead is safe for human ingestion. Young children, women of childbearing age and mothers who are breastfeeding face the highest health risks in eating food tainted with the toxic metal, officials said. The FDA said...
  • Trump directs FDA to limit DTC drug advertising, with legal challenges sure to follow

    09/10/2025 7:17:17 PM PDT · by E. Pluribus Unum · 28 replies
    Fierce Pharma ^ | Sep 10, 2025 11:28am | Kevin Dunleavy
    President Donald Trump has delivered another blow in his ongoing battle with the pharma industry, signing a memorandum on Tuesday that directs the FDA to rein in direct-to-consumer (DTC) drug advertising.The initiative, which has long been a priority for Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., is designed to roll back a 1997 policy shift that gave drugmakers a greater ability to advertise their products on television by relaxing the requirements on the information they must reveal about a treatment’s side effects.In his directive, Trump cited the power of the FDA—vested by Congress in 1962—to regulate drug...
  • I promised 4 things: 1. to end covid vaccine mandates. 2. to keep vaccines available to people who want them, especially the vulnerable. 3. to demand placebo-controlled trials from companies. 4. to end the emergency.

    08/27/2025 12:57:23 PM PDT · by E. Pluribus Unum · 24 replies
    X.com ^ | 11:35 AM · Aug 27, 2025 | Secretary Kennedy✓ @SecKennedy
    In a series of FDA actions today we accomplished all four goals. The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded. FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors. The American people demanded science, safety, and common sense. This framework delivers all three. Thank you @DrMakaryFDA for your leadership.
  • FDA Investigating Possibly Radioactive Shrimp Sold at Walmart, Warns Public Not to Eat

    08/19/2025 12:43:48 PM PDT · by nickcarraway · 52 replies
    ABC7 ^ | Tuesday, August 19, 2025
    Officials said, at this time, no product that has tested positive or alerted for Cesium-137 (Cs-137) has entered the U.S. commerceThe FDA is warning the public about possibly radioactive shrimp that may have been sold at Walmart in 13 states. The warning is for some Great Value raw frozen shrimp because it may be contaminated with Cesium-137, a radioactive isotope, the FDA announced on Tuesday. The products include the following product names, lot codes, and best by dates: Great Value brand Frozen Raw Ez Peel Tail-On Farm-Raised White Vannamei Shrimp, 2lb bag, lot code: 8005540-1, Best by Date: 3/15/2027 Great...
  • Senate confirms Susan Monarez as CDC director. Here's what she's said about vaccines, fluoride and more

    08/10/2025 9:55:25 AM PDT · by CondoleezzaProtege · 9 replies
    CDC ^ | July 29, 2025 | Sara Moniuszko
    The U.S. Senate voted… along party lines, 51 to 47, to confirm Susan Monarez as the new director of the Centers for Disease Control and Prevention. Monarez has been serving as the acting head of the CDC since January, and previously worked as the head of the Advanced Research Projects Agency for Health. At her confirmation hearing before the Senate's Health, Education, Labor and Pension (HELP) committee on July 9, Monarez garnered praise from the Republican chairman, Sen. Bill Cassidy, who is a physician, for her commitment to rebuilding public trust in the wake of the COVID-19 pandemic. Democratic Sen....
  • Vinay Prasad returns to the FDA, weeks after his ouster

    08/09/2025 7:38:54 PM PDT · by GrootheWanderer · 12 replies
    Stat ^ | Aug. 9, 2025 | Lizzy Lawrence
    Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene therapy, and blood product regulation. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and Human Services spokesman Andrew Nixon told STAT on Saturday.
  • President Trump has just ORDERED all federal agencies to DELETE employees’ COVID-19 vaccination statuses

    08/08/2025 6:09:30 PM PDT · by george76 · 94 replies
    X ^ | Aug 8, 2025 | Nick Sortor
    President Trump has just ORDERED all federal agencies to DELETE employees’ COVID-19 vaccination statuses They also must delete any records of vaccine non-compliance and exemptions FINALLY! NOBODY should be discriminated against for refusing the vax! .... never forget the amount of evil that took place during Covid ... It turned neighbors and family members against each other. . ... Crimes against humanity ... Never forget. ... US Employers must do the same. And any Employer who enforced the mandate must pay all vaccine injury related medical bills of past and present employees they forced to get a jab
  • Mercury BANNED in US Vaccines

    08/05/2025 5:46:39 AM PDT · by delta7 · 24 replies
    Armstrong Economics ^ | 5 Aug 25 | Martin Armstrong
    HHS Secretary Robert F. Kennedy Jr.’s next step toward making America Healthy again is an outright ban on thimerosal, a mercury-based preservative, found in common vaccines. “I’m proud to finally deliver on a long-overdue promise: protecting our most vulnerable from unnecessary mercury exposure,” Kennedy stated on a video posted on X, noting that the chemical is a known neurotoxin that has been administered to millions of Americans. The former director of the FDA, Willian Egan, admitted in 2001 that the safety of this preservative had never been studied. The government simply allowed the pharmaceutical agencies to incorporate it in vaccines...
  • 'Hidden hand': MAGA Republicans slam Laura Loomer as a Big Pharma 'plant'

    08/05/2025 8:31:56 AM PDT · by CondoleezzaProtege · 9 replies
    NewsBreak ^ | August 4, 2025 | Adam Lynch
    ...Some of Loomer’s erstwhile political allies are starting to wonder if there might be a hidden hand behind some of her most influential denunciations. Sommer says the firing in question involves last Tuesday’s ouster of Dr. Vinay Prasad as the head of a key treatment-approval division of the Food and Drug Administration. Prasad was a hero in Secretary of Health and Human Services Robert F. Kennedy Jr.’s MAHA movement because of his criticism of pandemic measures. But Loomer accused Prasad of disloyalty to Trump — even claiming that Prasad had admitted to having a Trump voodoo doll. Stat News reports...
  • US FDA's top vaccine official Vinay Prasad leaves agency after 3 months

    08/05/2025 8:21:06 AM PDT · by CondoleezzaProtege · 10 replies
    Reuters ^ | July 30, 2025 | Bhanvi Satija
    The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as Director of the Center for Biologics Evaluation and Research, a government spokesperson said. Prasad, an oncologist who was a fierce critic of U.S. COVID-19 vaccine and mask mandates, had been appointed in May by FDA Commissioner Marty Makary. Together they had promised to speed regulatory action and pilot new review pathways. In recent days, criticism of Prasad's tenure has intensified around the agency's handling of a gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics (SRPT.O), opens new tab. The...
  • Avoiding discussion of vaccine side effects isn’t pro-vaccine. It’s anti-science.

    07/21/2025 9:47:38 AM PDT · by CondoleezzaProtege · 10 replies
    Harvard Journal of Public Health ^ | Oct 2024 | Anthony Flint
    “I wear no tin-foil hat. I’m asking for the ability to officially document what happened to me.” Three and a half years ago I contracted Guillain Barre Syndrome after getting the Jansen-J&J viral vector vaccine for COVID-19. The neurological disorder has left me hobbled by numb hands and feet, staggering around imbalanced, and battling debilitating fatigue. It has also left me, and thousands of others, feeling ignored and unheard by the government and the public health establishment. I wrote about the experience in 2021 in The Boston Globe, after the FDA attached a warning to the J&J shot, citing an...