Tag Archives: FDA

FDA Asked To Probe Musk’s Brain Implant Company

Reuters reports: A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans. Reuters reported last month that FDA inspectors found problems with record keeping and quality controls for animal experiments at Neuralink last June, less than …

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Feds Fine Family Dollar $41 Million For Rat Infestations

NBC News reports: Family Dollar Stores was this week ordered to pay $41.6 million for using a rodent-infested warehouse to distribute food, cosmetics and medical devices to more than 400 stores across the South. The largest criminal penalty of its kind comes after a U.S. Food and Drug Administration investigation found “live rodents, dead and decaying rodents, rodent feces, urine, …

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FDA Allows Florida To Import Drugs From Canada

Axios reports: The Food and Drug Administration on Friday approved a plan allowing Florida to import cheaper prescription drugs from Canada, opening the door for states to buy direct from pharmacies there to stock their state-run health programs. The approval, the first of its kind, allows the Biden administration to show it’s addressing a major voter concern in an election …

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Politicians Shrug At US Decline In Life Expectancy

The Washington Post reports: Americans’ life expectancy decline remains a pressing public health problem — but not a political priority. The Washington Post spoke with more than 100 public health experts, lawmakers and senior health officials, including 29 across the past three presidential administrations, who described the challenges of attempting to turn around the nation’s declining life expectancy. Those challenges …

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High Lead Levels Found At Ecuador Applesauce Plant

The Washington Post reports: A U.S. inspection of a plant in Ecuador that manufactured pouches of contaminated applesauce linked to at least 125 cases of suspected lead poisoning in children found “extremely high” levels of the metal in a key ingredient: cinnamon. The Food and Drug Administration said Monday that samples of cinnamon from the plant that were tested contained …

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FDA: Applesauce Lead Poisonings May Be Intentional

NBC News reports: The lead contamination in recalled cinnamon applesauce pouches that potentially poisoned at least 65 children may have been intentional, the Food and Drug Administration said on Friday. The FDA has been investigating the lead contamination in the cinnamon-flavored applesauce products from Florida-based food manufacturer WanaBana since October. The agency has homed in on the cinnamon specifically as …

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GOP To Investigate FDA Over Ruling On Decongestants

Axios reports: Republicans on a House oversight panel will investigate the Food and Drug Administration’s handling of a common decongestant ingredient that the agency recently concluded was ineffective, the committee told Axios first. Rep. Lisa McClain (R-Mich.), chairwoman of the House Oversight subcommittee on health care and financial services, in a letter being sent today will request a briefing with …

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FDA Approves Eli Lilly Diabetes Drug To Treat Obesity

The New York Times reports: The decision by the Food and Drug Administration on Wednesday to approve the weight loss drug tirzepatide adds a potent new tool to the fast-growing arsenal of obesity drugs. The drug, which will go by the brand name Zepbound, contains the same compound in the sought-after diabetes drug Mounjaro. Many people have used Mounjaro off-label …

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CVS Pulls Decongestants As FDA Says They Don’t Work

The Insider reports: CVS this week said it is pulling many popular decongestants from its shelves after advisors to the Food and Drug Administration said the active ingredient simply does not work. In September, an advisory panel to the FDA ruled that phenylephrine, when taken orally, is no better than a placebo despite being on the market for more than …

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Feds To Again Offer Free At-Home COVID Tests By Mail

The New York Times reports: The Biden administration, looking ahead to a possible winter surge of Covid-19, announced on Wednesday that it was reviving its program of offering Americans free coronavirus tests through the mail and would spend more than $600 million to buy tests from a dozen domestic manufacturers. The website for the program, covidtests.gov, will begin accepting orders …

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FDA Advisors: Popular Oral Decongestants Don’t Work

The Associated Press reports: The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in …

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FDA Approves New Pfizer And Moderna Boosters

Via press release from the FDA: Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and …

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FDA: Your COVID Test Might Not Be Expired After All

Changing America reports: Is it safe to use a COVID-19 test that is past the expiration? The answer, it turns out, depends on what brand of test you have. The FDA has extended that date for a number of different at-home COVID-19 tests. The expiration date for multiple lots of BinaxNow COVID-19 antigen tests that were sold at CVS, for …

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FDA Approves First Over-The-Counter Birth Control Pill

The New York Times reports: The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception. The medication, called Opill, will become the most effective birth control method available over the counter — more effective at …

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FDA Asked To Probe Very High Caffeine Energy Drink

NBC News reports: An influencer-backed energy drink that has earned viral popularity among children is facing scrutiny from lawmakers and health experts over its potentially dangerous levels of caffeine. On Sunday, Sen. Charles Schumer called on the Food and Drug Administration to investigate PRIME, a beverage brand founded by the YouTube stars Logan Paul and KSI that has become something …

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FDA Approves Drug That May Slow Down Alzheimer’s

NPR reports: The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer’s disease. The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who are in the early stages of the disease …

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FDA Issues Guidance For Psychedelic Drug Trials

Axios reports: Federal regulators are laying out guidance for psychedelic drug trials for the first time, in a move that could encourage the mainstreaming of substances like magic mushrooms and LSD as behavioral health treatments. Psychedelics are turning into a multi-billion industry and gaining widespread acceptance after decades of concerns about recreational use of the products — and the high …

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FDA Panel Recommends COVID Vaccine Booster For Fall

NBC News reports: Advisers to the Food and Drug Administration on Thursday recommended updating the Covid vaccines to target a circulating strain of the virus, while pushing for newer vaccines that provide longer-lasting protection. The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously in support of tweaking the shots to target an XBB strain, as well as dropping …

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FDA Warns: People Are Accidentally Drinking Poppers

Via press release from the FDA: A single mistake can prove fatal. We continue to receive reports of people dying or being severely injured after consuming poppers that resemble, and often mistaken for, popular energy shots. Drinking or inhaling poppers seriously jeopardizes your health. Health care providers are reporting increases in deaths and hospitalizations related to intentional ingestion or inhalation …

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FDA Loosens Restrictions On Gay/Bisexual Blood Donors

The Associated Press reports: Gay and bisexual men in monogamous relationships can donate blood in the U.S. without abstaining from sex, under a federal policy finalized Thursday by health regulators. The Food and Drug Administration guidelines ease decades-old restrictions designed to protect the blood supply from HIV. The agency announced plans for the change in January and said this week …

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