FDA clears a Spinal Simplicity 510(k) for its Wolffs Law Anterior Cervical Plate System.
FDA warns Malaysias TCT Neutraceuticals about CGMP violations in its manufacturing of OTC drugs.
Federal Register notice: CDER announces the Emerging Drug Safety Technology Meeting program for stakeholders to discuss the use of artificial intellig...
Insulet recalls (Class 1) its Omnipod DASH Insulin Management Systems Personal Diabetes Manager after receiving reports battery issues.
FDA warns Boca Raton, FL-based Cosmetic Solutions about CGMP and unapproved new drug violations in its manufacturing of finished drugs.
The Office of Pharmaceutical Quality FY 2023 annual report says drug quality assurance inspections were up 40% over FY 2022 and mutual recognition agr...
FDA lists three planned 2024 enhancements to the CDRH electronic medical device reporting system.
Medline Industries recalls its Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube.
