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...
FDAs Center for Veterinary Medicine launches its Export Certification Application and Tracking System, a new online system that allows U.S. animal foo...
Hyman, Phelps & McNamara asks FDA to provide examples to clarify specific items in the agencys draft guidance on emergency-use injectors, while the Jo...
FDA approves a Karyopharm Therapeutics supplemental NDA for Xpovio (selinexor), a selective inhibitor of nuclear export compound for treating adult pa...