Tag Archives: FDA

“We’ve got to talk about environmental toxins that cause cancer, not just the chemo to treat it. And maybe we need to treat more diabetes with cooking classes, not just throwing insulin at people. You know, scientists have been waving the flag for years, saying you’ve got to look at this body of scientific data, and the modern medical establishment …

CBS News reports: The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily in teen boys and young men, citing findings from a study published last year and new agency data. Orders to expand the …

The Guardian reports: Moderna said on Wednesday it had withdrawn an application seeking approval for its flu and Covid combination vaccine candidate after discussions with the US Food and Drug Administration. The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine, which it expects to …

Reuters reports: The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability this fall to older adults and those with a higher risk of developing severe illness, FDA leaders said on Tuesday. FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad …

The Hill reports: The Food and Drug Administration (FDA) announced Tuesday it will be moving to take ingestible prescription fluoride products for children off the market, citing concerns that the mineral alters the gut microbiome of children. Ingestible fluoride products are prescribed for children who are at a high risk of tooth decay. The majority of municipal water systems in …

USA Today reports: If you’ve recently purchased tomatoes, you may want to check the label. There have been two separate recalls affecting tomatoes sold across 14 states. Ray & Mascari Inc. was notified by Hanshaw & Capling Farms of Florida that they were recalling the lot of tomatoes it sent to be repackaged into the 4 Count Vine Ripe Tomatoes …

NBC News reports: The Food and Drug Administration confirmed Monday it was requiring drugmaker Novavax to run another clinical trial as part of the approval process for its Covid vaccine, which has been available under emergency use authorization since 2022. Dr. Marty Makary, the FDA’s commissioner, said the company is asking the agency to approve “a new product” based on …

Semafor reports: Food and Drug Administration Commissioner Martin Makary said Thursday he has “no plans to take action” to restrict the availability of mifepristone, the pill used in most medication abortions in the US. Speaking at the Semafor World Economy Summit, Makary took a firmer stance on the issue than he did in his Senate confirmation hearing last month, when …

Axios reports: Food and Drug Administration databases that physicians and public health experts rely on for key drug safety and manufacturing information have been neglected due to DOGE-directed layoffs, leaving health professionals flying blind on basic questions about certain drugs they’re prescribing, current and former FDA officials tell Axios. Information gaps that have become a hallmark of the workforce reductions …

Reuters reports: The Food and Drug Administration is suspending a quality control program for testing of fluid milk and other dairy products due to reduced capacity in its food safety and nutrition division, according to an internal email seen by Reuters. The suspension is another disruption to the nation’s food safety programs after the termination and departure of 20,000 employees …

CBS News reports: The Food and Drug Administration is drawing up plans that would end most of its routine food safety inspections work, multiple federal health officials tell CBS News, and effectively outsource this oversight to state and local authorities. The FDA is ultimately responsible for the safety of much of the U.S. food supply that’s distributed over state lines, …

CBS News reports: The Food and Drug Administration is finalizing plans to replace some of the employees it laid off with contractors, three FDA officials tell CBS News, after steep cuts to the agency’s workforce disrupted drug and food safety inspections. The contractors would effectively replace most of the work done by more than 50 laid-off federal employees who handled …

Politico reports: HHS Secretary Robert F. Kennedy Jr.’s visit to the FDA Friday was supposed to introduce him as a trusted leader to agency employees. It did anything but. Over the course of 40 minutes, Kennedy, in largely off-the-cuff remarks, asserted that the “Deep State” is real, referenced past CIA experiments on human mind control and accused the employees he …

Reuters reports: The Trump administration has fired staff who were working on the U.S. Food and Drug Administration’s bird flu response as part of its mass layoffs at the Department of Health and Human Services, according to a source familiar with the situation. The Tuesday firings, which many employees learned of as they attempted to enter office buildings and were …

Fast Company reports: Poppers have always operated in a legal gray zone. Now the Food and Drug Administration (FDA) is cracking down on their production. This week, many major poppers brands began wiping their websites and social media presences. On Friday, Double Scorpio, a popular isobutyl nitrite brand, posted a statement on its website. “Double Scorpio has stopped all operations …

The New York Times reports: A panel of scientific experts that advises the Food and Drug Administration on vaccine policy — and that has been the target of criticism from Health Secretary Robert F. Kennedy Jr. — learned on Wednesday that its upcoming meeting to discuss next year’s flu vaccines had been canceled. The F.D.A. sent an email to members …

Reuters reports: U.S. Food and Drug Administration scientists have been told to stop using the words “woman,” “disabled” and “elderly” in external communications, part of a list of banned terms that a White House spokesman said had misinterpreted Trump’s executive order. A list with the file name “Prohibited words” has been circulating since at least last week in official work …

The New York Times reports: Jim Jones, the director of the Food and Drug Administration’s food division, resigned on Monday, citing what he called “indiscriminate” layoffs that would make it “fruitless for him to continue.” In his resignation letter, Mr. Jones estimated that 89 people of the 2,000 in his division were fired over the weekend, many of them freshly …

Reuters reports: Food and Drug Administration employees reviewing Elon Musk’s brain implant company Neuralink were fired over the weekend as part of a broader purge of the federal workforce, according to two sources with knowledge of the matter. The cuts included about 20 people in the FDA’s office of neurological and physical medicine devices, several of whom worked on Neuralink, …

The Washington Post reports: A federal judge on Tuesday ordered the nation’s premier health agencies to restore online access to several websites that monitor HIV, health risks for youths, and assisted reproductive technologies, which were abruptly taken offline to ensure they complied with Trump’s recent executive order on gender. U.S. District Judge John D. Bates granted a temporary restraining order …