Two Argent Fox Schiff attorneys describe an FDA proposed rule that would change how some drug manufacturers register their facilities and list their p...
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vuso...
FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal...
FDA posts the following user fee rates for medical product programs for fiscal year 2027.
FDA releases the form FDA-483 with nine observations from an inspection at the Edison, NJ-based Bentley Laboratories over-the-counter drug manufacturi...
Resmed recalls its Astral 100/150 ventilator system due to the potential for a supercapacitor electrolyte leakage on the printed circuit board assembl...
Bloomberg reports that Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administration as the leading c...
FDA issues Dr. Reddys a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspection at the companys...
