Federal Register notice: FDA determines that dextrose in plastic container injectable, 30g/100mL, 40g/100mL, 60g/100mL, and 70g/100mL, were not withdr...
FDA approves a Mainstay Medical Holdings PMA for ReActiv8, an implantable neurostimulation system to treat intractable chronic low back pain.
FDA releases its latest batch of Warning Letters that includes BHP Holdings, KBMO Diagnostics and Nanobots Healthcare.
FDA commissioner Stephen Hahn and CBER director Peter Marks say the agency has been taking compliance and enforcement actions against unapproved regen...
The FDA Oncology Center of Excellence launches the pilot of a Project Patient Voice Web site with patient-reported symptoms from cancer trials for mar...
FDA warns Nanobots Healthcare about violations in its production of sterile drugs.
FDA warns BioPure Healing Products that its dietary supplements are adulterated and misbranded.
Due to an inspection moratorium, FDA sends Nabriva Therapeutics a complete response letter on its NDA resubmission seeking marketing approval of Conte...