FDA warns about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compounded semaglutide inj...
FDA issues a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin (XXX DE-ITALICIZE XXX)and its use in improving glycemic...
A new CDRH blog post outlines key activities that should be taking place during the lifecycle of artificial intelligence-enabled medical devices.
FDA clears a bioMrieux 510(k) for its Biofire Spotfire Respiratory/Sore Throat Panel Mini for detecting five of the most common viral and bacterial ca...
FDA says Aurobindo has recalled one lot of its OTC Healthy Living migraine medication that was distributed through Amazon without the FDA-approved lab...
FDA publishes a Veterinary International Conference on Harmonization revised guidance on residual solvents used in animal drugs.
Federal Register notice: FDA makes available a final guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...
Medtronics Xomed unit recalls (Class 1) its NIM Vital Nerve Monitoring system due to the potential for false negative responses.
