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Keyword: fda

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  • FDA Commissioner Marty Makary Will Conduct Full Review of Dangerous Abortion Pill

    06/03/2025 1:00:44 PM PDT · by Morgana · 1 replies
    Life News ^ | June 3, 2025 | Steven Ertelt
    In a letter to pro-life Senator Josh Hawley of Missouri, FDA Commissioner Marty Makary has committed to conducting a full review of the dangerous abortion pill – which has killed and injured countless women. Makary made the commitment after Senator Josh Hawley sent a letter highlighting new research showing greater risks than the FDA currently acknowledges and urging Makary to reconsider his earlier statement that he had “no plans to take action.” “As Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone,” the FDA chief said in a letter to the senator, who highlighted it...
  • FDA Updates Tomato Recall To Most Serious Classification, “Serious Adverse Health Consequences Or Death”

    06/03/2025 1:21:33 PM PDT · by Red Badger · 32 replies
    100 Percent Fed Up ^ | May 30, 2025 | Staff
    The Food and Drug Administration (FDA) issued a Class I recall, the most serious designation, for tomatoes potentially containing deadly bacteria. Class I recalls indicate a potential for “serious adverse health consequences or death.” Williams Farms Repack LLC recalled multiple tomato sizes due to potential salmonella contamination. The FDA updated the recall to Class I designation on Wednesday. Williams Farms Repack LLC Recalls Tomatoes Due to Possible Salmonella Contamination https://t.co/VZrbo0NEfQ pic.twitter.com/whsBY5IZTD — U.S. FDA Recalls (@FDArecalls) May 2, 2025 Daily Mail reports: The recall covers shipments from April 23 to April 28 sold in Georgia, North Carolina and South Carolina....
  • Sarah Brenner, the No. 2 at the FDA, refused the COVID vax

    05/22/2025 8:30:08 AM PDT · by SeekAndFind · 17 replies
    American Thinker ^ | 05/22/2025 | Benjamin Rushe
    Sara Brenner, worked as a career employee at the FDA until she was recently promoted to the No. 2 position under the new FDA Commissioner. Marty Makary. Brenner has recently stated that she never took the COVID vaccine despite it being a requirement for federal employees.Brenner’s reasoning was that she was pregnant and concerned about the safety of the vaccine for both her and her child. Perhaps she arrived at that conclusion because she’s an expert on nanobiotechnology (although the picture she provided at the link is a curious choice), and therefore had serious and fully legitimate clinical reservations.The question...
  • FDA says Covid boosters will now need clinical trials to prove effectiveness in healthy people under 65

    05/20/2025 12:31:43 PM PDT · by Red Badger · 42 replies
    Not The Bee ^ | May 20, 2025 | Staff
    Welcome to the age of reason, my friends. In a bid to stop beta-testing vaccine variations on everyday citizens, the new Federal Drug Administration (FDA) leaders are rolling out rules that pharmaceutical companies need to actually prove the effectiveness of Covid boosters for people under 65 without co-morbidities using randomized clinical trials. For people over 65 and with co-morbidities, the FDA says that there's ample evidence they have a healthy immune response from the boosters. But for healthy young people, FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine: We...
  • FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say

    05/20/2025 11:46:03 AM PDT · by ChicagoConservative27 · 34 replies
    statnews ^ | 05/20/2025 | By Helen Branswell, Matthew Herper, and Lizzy Lawrence
    The Food and Drug Administration announced Tuesday that it will limit access to Covid-19 vaccines going forward to people 65 years of age and older and others who are at high risk of becoming seriously ill if they are infected, and will require manufacturers to conduct clinical trials to show whether the vaccines are of benefit to healthy younger adults and children. After weeks of signaling a shift in thinking, the new leaders of the FDA and the agency’s division that regulates vaccines published a commentary in the New England Journal of Medicine laying out their plan for future use...
  • FDA Clears First Blood Test for Alzheimer's Diagnosis

    05/16/2025 1:52:40 PM PDT · by nickcarraway · 13 replies
    MEDPAGE TODAY ^ | May 16, 2025 | Judy George
    Plasma assessment is not intended as a screening or stand-alone diagnostic test, agency saysThe FDA cleared the first blood-based in vitro diagnostic test for Alzheimer's disease, the agency announcedopens in a new tab or window Friday. The blood test, known as the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, can be used to detect amyloid plaques associated with Alzheimer's in people ages 55 and older who have signs and symptoms of the disease, the agency said. "Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined," FDA Commissioner Martin Makary, MD, MPH, said in a statement....
  • Weight Loss Drugs Have "No End Game" Amid Lack of Data on Long-Term Use, Former FDA Commissioner Warns

    05/16/2025 1:01:55 PM PDT · by nickcarraway · 6 replies
    CBS News ^ | 5/14 | Sara Moniuszko
    HealthWatch Weight loss drugs have "no end game" amid lack of data on long-term use, former FDA commissioner warns healthwatch By Edited By May 13, 2025 / 1:03 PM EDT / CBS News Weight loss drugs have transformed how Americans lose weight, including former commissioner for the U.S. Food and Drug Administration Dr. David Kessler. But, Kessler warns there are unknowns about long-term use of the drugs and how to get people off them. "There is no end game," he said on "CBS Mornings Plus" Tuesday. "FDA allowed these medicines out without a long-term strategy." Kessler faced unexpected weight gain...
  • ‘The label should be changed’: HHS Sec Kennedy pledges to review FDA approval of abortion drug

    05/15/2025 10:13:29 AM PDT · by Morgana · 4 replies
    Catholic Vote ^ | May 14, 2025 | Joshua Mercer
    CV NEWS FEED // Health and Human Services Secretary Robert F. Kennedy, Jr. said Wednesday that he has ordered a top-down review of the abortion drug mifepristone in light of “alarming” research showing the Food and Drug Administration (FDA)-approved pill does far more harm to women than previously reported. The latest research is “alarming,” Kennedy said during a hearing before the Senate Health, Education, Labor and Pensions Committee. “And clearly it indicates at the very least the [FDA] label should be changed.” “I’ve asked Marty Makary, who’s the director of the FDA, to do a complete review and to report...
  • FDA to ban fluoride prescription products for kids, citing evidence it can lower child IQs

    05/14/2025 5:12:28 PM PDT · by Twotone · 13 replies
    The Blaze ^ | May 13, 2025 | Andrew Chapados
    The U.S. Food and Drug Administration is taking action to remove ingestible fluoride prescription drugs for children off the market. In a press release, the FDA said products that are swallowed offer significant risk to infants and toddlers, unlike toothpaste with fluoride or fluoride rinses. The FDA also said the ingestion of fluoride products comes with risks like problems with the early development of the gut microbiome in childhood, thyroid disorders, weight gain, and decreased IQ. The federal agency provided links to several studies that point to worrying effects in children, especially in regard to their IQ. A meta-analysis of...
  • Government Admits it Knew Covid Vax Shots were Fraud – Karen Kingston

    05/07/2025 4:42:14 AM PDT · by Tom Tetroxide · 156 replies
    USAWatchdog.com ^ | 7MAY2025 | Greg Hunter
    Karen Kingston is a biotech analyst and former Pfizer employee who is back with some grotesque news about what the US government knew about the CV19 bioweapon vax. They knew it was not safe at all, and the FDA also knew Pfizer committed fraud to get the CV19 injections approved. Kingston says, “This is the government’s words exactly: ‘The FDA was aware of the protocol violations.’ So, the FDA was aware of the fraud that was reported . . . before it granted emergency use authorization (EUA) for its vaccine. They were aware of the fraud. Second, the government said...
  • Politics Trump administration urges judge to toss states' lawsuit over access to abortion pill mifepristone

    05/06/2025 7:41:32 AM PDT · by Coronal · 5 replies
    CBS News ^ | May 5, 2025 | Melissa Quinn
    Washington — The Trump administration on Monday urged a federal district court to dismiss a lawsuit challenging the Food and Drug Administration's actions expanding access to the widely used abortion pill mifepristone. Justice Department lawyers wrote in a filing with the U.S. district court in Amarillo, Texas, that the three states pursuing the lawsuit — Missouri, Idaho and Kansas — should not be able to do so in that court. The administration is pursuing a request initially made by the Biden administration last year in the closely watched challenge to mifepristone, a drug used to terminate an early pregnancy, that...
  • Largest-Ever Study of Abortion Pill Reveals Shocking Number of Adverse Events

    04/29/2025 3:31:47 PM PDT · by Morgana · 21 replies
    Ethics and Public Policy Center ^ | April 28, 2025 | staff
    New study reveals an adverse event rate 22 times higher than the FDA-approved drug label reports. (Washington, DC): In a first-of-its-kind study, “The Abortion Pill Harms Women”, the Ethics and Public Policy Center (EPPC) reveals that serious adverse events from mifepristone are approximately 22 times more frequent than the Food and Drug Administration (FDA) currently recognizes. The study shows that, following a mifepristone abortion, 10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious or life-threatening adverse event. That is, over one in ten patients experience at least one serious adverse event. The study, authored by Jamie Bryan Hall,...
  • Exclusive — Shocking Data Suggests Abortion Pill Complications 22 Times Higher Than Previously Reported: ‘FDA Must Reinstate Stronger Safeguards

    04/28/2025 8:09:01 AM PDT · by bimboeruption · 21 replies
    Breitbart ^ | 4-28-25 | Katherine Hamilton
    While the abortion pill is touted as “safe and effective,” shocking new data suggests complications are 22 times higher than previously reported. A study from the Ethics and Public Policy Center released on Monday found that 10.93 percent of women who had mifepristone abortions — the first drug used in a two-drug medication abortion regimen — experienced severe complications including sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following the abortion. This percentage is significantly higher than the less than 0.5 percent in clinical trials reported on the FDA-approved drug label. The study is the “largest-known study...
  • MAHA – Petroleum-Based Food Dye Ban

    04/24/2025 5:54:22 AM PDT · by delta7 · 22 replies
    Armstrong Economics ^ | 24 Apr 25 | Martin Armstrong
    The Food and Drug Administration and the US Department of Health and Human Services have announced a ban on all petroleum-based synthetic food dyes beginning in 2026. Robert F. Kennedy has warned for years that America’s food supply has been compromised with chemicals that have aided in causing America to be the sickest nation in the developed world. The FDA is taking the following actions: Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives. Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within...
  • FDA Suspends Milk Testing: What It Means for Your Health

    04/23/2025 3:25:01 AM PDT · by EBH · 52 replies
    Men's Journal ^ | 4/23/25
    The U.S. Food and Drug Administration (FDA) has suspended its quality control program for testing fluid milk and other dairy products, citing reduced capacity in its food safety and nutrition division. This decision follows the termination and departure of 20,000 employees from the Department of Health and Human Services (HHS), part of a broader federal workforce reduction initiative. ​ Reuters reported, effective April 21, the U.S. Food and Drug Administration has suspended its quality testing program for Grade A milk and other dairy products, citing massive staffing losses tied to federal budget cuts. While the move may seem bureaucratic, it...
  • Pharma Employees Removed From FDA Advisory Committees, FDA Commissioner Announces

    04/17/2025 8:26:27 PM PDT · by Beave Meister · 8 replies
    100% Fed Up.com ^ | 4/17/2025 | Danielle
    U.S. Food and Drug Administration (FDA) Commissioner Martin Makary announced a new policy directive limiting employees of companies the agency regulates, such as pharmaceutical companies, from serving as official members of FDA advisory committees. “While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” Makary said. “Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans,”...
  • I Survived Leukemia Because of a Clinical Trial. Will Future Patients Be So Lucky?

    04/15/2025 11:35:40 AM PDT · by nickcarraway · 23 replies
    MEDPAGE TODAY ^ | April 15, 2025 | Robert L. Dilley, MD, PhD
    Sustained research funding is essential to progressI don't usually talk about my cancer diagnosis. But as a physician-scientist who survived leukemia at 18 years old and now cares for people facing their own cancer diagnoses, I feel compelled to share my story -- because it speaks directly to what's at stake in medicine today. The clinical trial that saved my life wouldn't have existed without robust investment in biomedical research. And as debates over federal research funding continue, I think about whether future patients will have access to the same life-saving opportunities I did. It was the summer of 2007....
  • FDA Grants Fast Track Designation for Potential Bird Flu Vaccine

    04/14/2025 7:38:04 AM PDT · by dynachrome · 50 replies
    Drug Topics ^ | 4-11-25 | Ashley Gallagher
    The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024. The FDA granted fast track designation for a self-amplifying mRNA vaccine candidate (ARCT-2304) for active immunization to protect against influenza A H5N1 subtype, also known as bird flu. The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial (NCT06602531) of the vaccine was initiated in November 2024. H5N1, Influenza, Bird flu, Immunization The designation addresses the unmet need for prevention...
  • EXCLUSIVE: What Has HHS Withheld on COVID-19 Vax? Sen. Ron Johnson Is About to Find Out

    12/15/2024 1:06:53 PM PST · by george76 · 14 replies
    Daily Signal ^ | December 12, 2024 | Fred Lucas
    A new letter from Sen. Ron Johnson, R-Wis., puts federal health agencies on notice that he plans to subpoena unredacted records withheld by the Biden administration on potential adverse effects of the COVID-19 vaccines. “It appears that even in the waning days of the Biden administration, your agencies will remain defiant in providing the public with complete information about the COVID-19 vaccines,” writes Johnson, incoming chairman of the Senate’s Permanent Select Subcommittee on Investigations, in the Dec. 5 letter shared with The Daily Signal. “If it becomes necessary to subpoena these and other requested records in the next Congress when...
  • Why Hasn't RFK Jr. Paused Drug Ads?

    04/05/2025 1:46:56 PM PDT · by nickcarraway · 36 replies
    MEDPAGE TODAY ^ | April 3, 2025 | Lao-Tzu Allan-Blitz, MD, MPH, and Jeffrey D. Klausner, MD, MPH
    Reports of over-prescribing and excess drug spending make regulation necessaryDrug commercials have become commonplace in the U.S. The average American watches more than nine drug advertisements a day, or more than 16 hours a yearopens in a new tab or window. Only two countries in the world, the U.S. and New Zealandopens in a new tab or window, permit direct-to-consumer marketing of prescription medications. Since the practice became routine in the 1990s, concerns have been voiced about how such marketing creates unhelpful and even harmful pressures on patients, doctors, and communities. And while those concerns are not new, recent reports...