Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.

US Food and Drug Administration layoffs appear to be affecting programs that track drug safety. Fired workers from the Division of Drug Information, which conducts safety monitoring, say the DDI team ...

Harvard Pilgrim Health Care Inc. will develop a prototype of the Food and Drug Administration’s Sentinel national drug safety monitoring system under a contract potentially worth $72 million over five ...

The update now reduces the frequency of liver function monitoring to every 3 months from the onset of treatment. The Food and Drug Administration (FDA) has updated the risk evaluation and mitigation ...

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. The FDA has removed the Risk Evaluation and ...

FDA lowers echo monitoring to every 6 months for select Camzyos patients in maintenance phase. Camzyos label update removes prior contraindications with certain CYP inhibitors. See the trading ...

PARIS--(BUSINESS WIRE)--DentalMonitoring®, the leader in AI-powered remote monitoring for orthodontic treatment, has received De Novo approval from the U.S. Food and Drug Administration (FDA) for the ...

From a global regulatory perspective, Cytokinetics is expanding its footprint rapidly. The drug received approval in China on ...