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 FDA eliminated the REMS program and shortened both the post-infusion driving restriction and the required duration of proximity to a healthcare facility. The Food and Drug Administration (FDA) has ...
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 ...
Continuous monitoring systems support regulatory compliance through automated environmental tracking and real-time alert capabilities.
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 ...
More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...
FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
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