FDA clears an OrthoGrid Systems 510(k) for its application PhantomMSK Trauma for use in orthopedic surgery.
New Government Accountability Office findings on FDAs foreign inspection program acknowledge improvements pointing up persistent remaining challenges,...
FDA releases its latest batch of Warning Letters that includes OHM Pharma and Teligent Pharma.
Sesen Bio begins a rolling BLA for vicinium for treating BCG-unresponsive non-muscle invasive bladder cancer.
Federal Register notice: FDA makes available a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treat...
FDA clears a LimaCorporate and TechMah Medical 510(k) for the Smart Space Shoulder 3D Planner & 3D Positioner for shoulder arthroplasty.
Genus Medical Technologies wins a court decision against FDA to have its contrast agent Vanilla SilQ products regulated as devices as opposed to drugs...
FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and ranitidine have now s...