Keyword: fda
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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...
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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...
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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,...
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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...
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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...
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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...
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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,”...
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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....
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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...
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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...
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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...
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Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week in support staff. Around 170 workers were cut from the FDA's Office of Inspections and Investigations, according to two federal health officials who were not authorized to speak publicly. One of the biggest immediate impacts on the agency's inspectors stems from the elimination of the office's travel operations division, one official said. The team's work ranged from booking flights to coordinating with the State Department to secure translators...
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Dr. Marty Makary has been confirmed as the new head of the Food and Drug Administration (FDA). Makary, a Johns Hopkins University surgeon and researcher, was confirmed by the Senate with a 56-44 vote. During his Senate hearing, Makary said "common sense" should be used in health care alongside science. - While he is generally supportive of vaccines, in the past Makary has opposed blanket vaccine mandates for people other than health care workers. -He has previously made headlines for his comments during the COVID-19 pandemic, which included looking at natural immunity and questioning the requirement for booster shots in...
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Dr. Peter Marks, the agency’s top vaccine official and a key figure in the first Trump administration’s Operation Warp Speed, has been ousted from his post. Dr. Peter Marks is an American hematologist-oncologist who has served as the director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) since 2016. As CBER director, Marks was responsible for reviewing and providing advice during product development, evaluating applications, and making approval decisions based on safety and effectiveness data. He oversaw the FDA’s vaccine programs and played a pivotal part in the rapid development and...
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The Food and Drug Administration’s top vaccine official, Dr. Peter Marks, abruptly resigned Friday, saying in a searing letter that Health Secretary Robert F. Kennedy Jr.’s aggressive stance on vaccines was irresponsible and posed a danger to the public... Dr. Marks resigned under pressure, according to a person familiar with the matter who said an official with the Department of Health and Human Services told Dr. Marks on Friday that he could either resign or be fired...
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Florida's controversial surgeon general, Dr. Joseph Ladapo, and a former Texas Republican congressman, Dr. Michael Burgess, are each being backed by some of President Trump's allies to be the next head of the Centers for Disease Control and Prevention. The White House is searching for a replacement after the nomination of Dr. Dave Weldon, a former Florida congressman, was abruptly pulled last week. White House officials have said internally that they are trying to "get it right" with their next pick, multiple administration officials said, seeking to address concerns about a prolonged vacancy at the agency or the prospect of...
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President Trump’s second term in office has been off to a frenzied start, with much of his actions revoking Biden-era proposals and policies. The 46th president exceeded expectations for the depths he was willing to go with last-minute, perplexing decisions such as the one to advance a Food and Drug Administration proposal to establish nicotine limits for tobacco products. It was a final disappointment in a presidency full of them and a final parting gift to cartels and lawbreakers.However, President Biden’s blunder allows Mr. Trump to fix this mistake and chart a more productive path.The proposed regulation would mandate a...
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WASHINGTON (AP) — Thousands of employees returned to the Food and Drug Administration’s headquarters Monday to find overflowing parking lots, long security lines and makeshift office spaces without chairs and other basic supplies. The FDA is the latest agency scrambling to meet the Trump administration’s return-to-office mandate, part of a flurry of actions — including firings and buyouts — intended to radically shrink the federal workforce. Monday was the first day that all rank-and-file FDA staffers were required to report to offices, including the agency’s 130-acre campus just outside Washington. The Associated Press spoke with more than a half-dozen FDA...
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READ: https://t.co/Iw9Hszlfdt
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In a pro-life victory, the lawyer who defended abortion pills in court for the Biden administration has resigned as Chief Counsel for the FDA. Acting general Sean Keveney in the Department of Health and Human Services (HHS) picked an attorney as the agency’s top lawyer who defended the abortion pill during the Biden administration. Perkins defended the availability of abortion pills that have killed millions of babies in court as an attorney for the DOJ during the Biden administration. After just two days on the job and following pro-life criticism when news of Perkins’ selection became public news, Perkins has...
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