FDA warns Indias Intas Pharmaceuticals about CGMP and other violations at its drug manufacturing facility in Sanand, India.
FDA warns Alvin, TX-based Iso-Tex Diagnostics about CGMP violations in its production of finished drugs.
FDA warns Baxters Ahmedabad, India-based drug manufacturing facility about CGMP and other violations.
FDA clears a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device mild and moderate bleeding in cardiac surgical procedures a...
FDA approves a GSK supplemental BLA for Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by single-agent Jemperli for t...
FDA clears a Numares Health 510(k) for the Axinon LDL-p Test System, a test physicians can use to measure lipoproteins for patients at risk for cardio...
FDA announces the FY 2024 user fee rates for medical device submissions.
Federal Register notice: FDA announces the rates for prescription drug/biologic user fees for fiscal year 2024.
