FDA clears a Zetta Medical Technologies 510(k) for its Zoom software, an MRI software algorithm for image quality enhancement and image optimization o...
Federal Register notice: FDA announces a 7/12 Antimicrobial Drugs Advisory Committee meeting to review a GlaxoSmithKline NDA.
FDA Review posts the Federal Register notices for the week ending 6/22/18.
Federal Register notice: FDA makes available a draft guidance for industry entitled Major Depressive Disorder: Developing Drugs for Treatment.
A Trump Administration government reorganization proposal aims to rename FDA the Federal Drug Administration and remove and reassign all food-related ...
FDA accepts for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for treating first-line advanc...
Draeger Medical Systems begins a Class 1 recall of its Jaundice Meter JM-103 and JM-105 models which are used to measure bilirubin in newborn infants.
FDA permits the de novo marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney ...