A Friends of Cancer Research survey report documents bottlenecks in U.S. oncology clinical trial site scale-up activation and suggests ways to address...
FDA issues Gasco Industrial Corp. a Form 483 for significant and repeat GMP deficiencies following a 2/17-27 inspection of the company's over-the-coun...
Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug and biologic trials a...
FDA releases the form FDA-483 with three observations from an inspection at the Hayward, CA-based Allure Labs drug manufacturing facility.
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...
