FDA Spells Out Its 2027 Plans for Regulating AI Medical Devices
FDA lays out 2027 AI guidance plans, aiming to clarify how developers build, test, and submit AI-powered medical devices.
CLAY TRIBUNE / THE ARCHIVE
Tag: FDA
FDA approves PTSD drug developed overseas for US veterans
Trump's FDA brings a PTSD treatment back to America, ending the need for veterans to travel abroad for care.
The Technology to Eradicate Mosquito-Borne Disease Exists — the FDA Just Won’t Approve It
A gene drive can wipe out disease-carrying mosquitoes. The FDA has stalled approval for over a decade while outbreaks rage.
Over 122K Cases of Gatorade Recalled Over Undeclared Food Dyes
Gatorade pulls over 122,000 cases from shelves after FDA finds undeclared food dyes in Lemon Lime, Orange, and Zero flavors.
Stem Cell Advocates See RFK Jr.’s Influence Driving the Next Wave of Regenerative Medicine
Stem cell advocates see the FDA's openness toward peptides as a sign the agency may finally host public roundtables on their industry.
FDA Finds Cyclospora in Environment Where Recalled Lettuce Was Grown and Processed
FDA finds Cyclospora in wastewater and ditch where Taylor Farms grew recalled lettuce, confirming link to nationwide outbreak.
Invivyd’s bid to replace the Covid vaccine gets funding, though FDA approval still hangs over it
A small biotech firm's antibody rival to the vaccine holds promise, yet a bar set by the FDA may still stand before it.
Mezzetta Recalls Peperoncini After Dead Rodent Found in Jar
Mezzetta recalls a single batch of Golden Greek Peperoncini after a TikTok user found a dead baby mouse inside a jar.
UniQure Reports Gene Therapy Slows Huntington’s Disease Progression Over Four Years
UniQure's gene therapy slows Huntington's progression for four years, but data lacks statistical significance ahead of FDA review.
Medicare Ends Special Treatment for FDA ‘Breakthrough’ Devices This Month
Medicare ends special payments for FDA 'breakthrough' devices, closing a door opened in 2020 that now has a final list of devices grandfathered in.
FDA Nominee Heidi Overton Dances Around Mifepristone at Senate Hearing
FDA nominee Overton dodges senators' questions on abortion drug mifepristone, raising fears she'll cave to anti-abortion pressure.
How Big Tobacco Flooded the FDA With 175,000 Form Letters to Kill a Menthol Cigarette Ban
How Big Tobacco flooded the FDA with form letters to sink a menthol cigarette ban, and what the data reveals.