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 ...
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 ...
FDA Chief Says He Won’t Reorganize Agency After Mass Layoffs
The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...
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 ...
Medscape4h
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 ...
STAT2h
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.
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 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 Supra4h
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 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 Supra4h
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 ...