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 ...
STAT1m
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.
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 ...
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 ...
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 ...
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 ...
Medscape1h
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, ...
Bread sold in six states recalled over ‘glass fragments’: FDA
The rolls were sold at the retail level in Pennsylvania, California, Connecticut, Maryland, Delaware, and Ohio, according to ...
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 ...
JD Supra1h
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 ...
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 Supra1h
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 ...