Please provide your email address to receive an email when new articles are posted on . Two FDA committees overwhelmingly voted to strike down monitoring requirements under a Risk Evaluation and ...
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the ...
The Food and Drug Administration received more than 100 comments after seeking responses on how to monitor the real-world performance of artificial intelligence in medical devices. The feedback ...
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 ...
The FDA has eliminated REMS for BCMA- and CD19-directed CAR T-cell therapies, improving access and reducing provider burden. Hospitals no longer need special certification or immediate access to ...
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 ...
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 ...
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