FDA warns the South Miami, FL-based Larkin Community Hospital institutional review board about failing to adhere to statutory and regulatory requireme...
After three failed submissions, FDA accepts for review a Fabre-Kramer Pharmaceuticals NDA resubmission for Exxua (gepirone HCl) extended-release table...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Acacia Pharmas Byfavo (remimazolam).
The Service Employees International Union United Healthcare Workers West asks FDA to order five changes to certain Fresenius USA hemodialysis machine...
Five King & Spalding attorneys review the nine advertising and promotion enforcement letters FDA issued in 2022.
FDA clears a Tidepool 510(k) for its Tidepool Loop, an automated insulin dosing app intended for managing Type 1 diabetes in patients aged six years a...
An FDA clarifying notice says the agency will continue to make orphan drug exclusivity decisions based on a drugs specific approved uses/indications a...
FDA plans to discuss 1/26 a new strategy to annually select Covid-19 strains in June for immunizations beginning no later than September each year.
