FDA clears a SpineEX 510(k) for its Sagittae Lateral Lumbar Interbody (LLIF) Fusion System.
FDA issues Sun Pharmaceutical (Gujarat, India) a three-page Form 483 after a February inspection cited GMP deviations for finished pharmaceuticals.
FDA Review posts the Federal Register notices for the week ending 3/22/2019.
FDA issues a safety alert about cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronics im...
FDA makes available a draft guide entitled Rare Diseases: Natural History Studies for Drug Development.
FDA clears a Genetesis 510(k) clearance for its cardiac imaging platform, which pairs its CardioFlux Magnetocardiograph with the integrated Faraday An...
CDERs Office of Clinical Pharmacology (OCP) says that in 2019 it will focus on current health issues related to the opioid epidemic, antimicrobial res...
Federal Register notice: FDA announces a 4/26 Antimicrobial Drugs Advisory Committee meeting to discuss the safety and effectiveness of bacitracin for...