Two former Insys sales executives are sentenced to federal prison sentences for their role in a bribery and kickback scheme to promote use of the comp...
FDA approves a Medtronic PMA for the Micra AV, which it describes as the worlds smallest pacemaker with atrioventricular synchrony.
FDA warns Chinas Zhuhai Aofute Medical Technology Co. about CGMP and other violations in its manufacturing of finished drugs.
CDER launches its Drug Risk Management Board to facilitate rapid analysis and resolution of drug safety issues throughout the Center.
FDA publishes a guidance on computer-assisted detection devices applied to radiology images and radiology device data.
FDA releases its latest batch of Warning Letters that includes CGA Limited, Curewave Lasers, Tismor Health and Wellness, Vevazz and Zhuhai Aofute Medi...
FDA approves a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease.
A Government Accountability Office report describes six policy options for overcoming challenges to increasing the use of machine learning in drug dev...