FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
FDA posts the following user fee rates for medical product programs for fiscal year 2027.
FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
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 manufacturing facility.
Resmed recalls its Astral 100/150 ventilator system due to the potential for a supercapacitor electrolyte leakage on the printed circuit board assembly that may lead to interruption of ventilation therapy.
