News

FDA to undo some layoffs, after cuts to inspections and drug safety
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment ...
Medscape2h
FDA Approves First One-Time Topical Treatment for Recessive Dystrophic Epidermolysis Bullosa Wounds
In a phase 3 trial, 81% of wounds treated with autologous cell sheet-based gene therapy showed ≥ 50% healing at 6 months, ...
DOGE Fired Drug Testing Experts. The FDA Needs Volunteers to Finish Their Work
Cutting staff is quick way to lower your costs, but a haphazard approach like DOGE's could cost your company if you ...
US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...
STAT1h
How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
JD Supra2h
FDA Food Chemical Regulation After the MAHA Executive Order
Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive ...
Wegovy Recalled as FDA Warns Weight Loss Product 'Inappropriately Released'
A batch of the drug is under a limited voluntary recall after a shipping error exposed certain doses to improper temperatures.
Could changes at the FDA call the kosher status of milk into question? Many are asking.
According to halacha, or traditional Jewish law, milk is only kosher if it comes from a kosher animal. One way to ensure that ...
FDA Will Phase Out Food Dyes Used In Skittles, Gatorade And Froot Loops: What To Know
Food and drink companies will have to stop using petroleum-based dyes by the end of 2026, Health and Human Services officials ...
JD Supra3h
AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a ...
FDA announces voluntary recall of Trader Joe's sesame miso salad with salmon in multiple states, including Pa.
The FDA announced Monday that limited quantities of the product was voluntarily recalled because the topping packet may ...