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.
Federal Register notice: FDA makes available a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treat...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...
Sesen Bio begins a rolling BLA for vicinium for treating BCG-unresponsive non-muscle invasive bladder cancer.
FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and ranitidine have now s...
Federal Register notice: FDA releases a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Performance Based Pathway....