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    Keyword: fda
    
   
  
  
    
    
      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...
    
  
  
    
    
      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...
    
  
  
    
    
      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...
    
  
  
    
    
      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.
    
  
  
    
    
      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...
    
  
  
    
    
      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...
    
  
  
    
    
      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...
    
  
  
    
    
      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. 
    
  
  
    
    
      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...
    
  
  
    
    
      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 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 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
    
  
  
    
    
      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...
    
  
  
    
    
      ...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...
    
  
  
    
    
      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...
    
  
  
    
    
      “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...
    
  
  
    
    
      The Food and Drug Administration’s chief medical and scientific officer, Dr. Vinay Prasad, rejected two COVID-19 vaccines in May due to unknown risks despite experts’ confidence that they were safe, documents revealed.While both the Novavax vaccine and the newest generation of the mRNA Moderna vaccines had been signed off on by about 30 FDA vaccine officials, Prasad ended up writing overrides for each, restricting their use. Prasad argued that the threat of COVID-19 had decreased, changing the cost-benefit weight of receiving such a vaccine.“Even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits...
    
  
  
    
    
      The U.S. Food and Drug Administration (FDA) under the Trump administration has formally updated the safety labeling on all mRNA COVID-19 vaccines to reflect what many Americans have been warning about for years: a disturbingly high risk of myocarditis—particularly in young men—and the possibility of long-term, irreversible heart damage. The revised warnings apply to both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines and follow months of mounting pressure over transparency and accountability regarding the true risks of these experimental injections. The update stems from new studies and data showing persistent cardiac abnormalities months after vaccination—especially among males aged 12 to 24....
    
  
  
    
    
      Moderna on Monday said its experimental mRNA-based flu vaccine produced a stronger immune response than a currently available shot in a late-stage trial, clearing a path forward for the product and the company’s separate combination flu and Covid jab. Moderna in May voluntarily withdrew an application seeking approval of its combination shot targeting Covid-19 and influenza, saying it had plans to resubmit it with efficacy data from the phase three trial on its stand-alone flu vaccine. That decision came after discussions with the Food and Drug Administration, which is grappling with a massive overhaul under Health and Human Services Secretary...
    
  
  
    
    
      One of the most powerful figures at the US Food and Drug Administration (FDA) has admitted she refused the Covid-19 mRNA vaccine while pregnant—even as her agency promoted it as “safe and effective” for all pregnant women. Dr Sara Brenner’s explosive disclosure, made on 15 May 2025 at the MAHA Institute Round Table in Washington, DC, is as revealing as it is troubling. A preventive medicine physician, Brenner has worked at the FDA since 2019. As the FDA’s Principal Deputy Commissioner—and briefly its Acting Commissioner—Brenner was at the centre of decision-making. [snip] Brenner explained that her decision was driven by...
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