The US Food and Drug Administration (FDA) has been using the Risk Evaluation and Mitigation Strategies (REMS) program as a way to mitigate adverse events stemming from opioid misuse and abuse, but ...

US regulators removed a special safety program intended to monitor for certain heart risks with vandetanib (Caprelsa), a drug first approved in 2011 to treat medullary thyroid cancer in patients whose ...

The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.

Risk evaluation and mitigation strategy (REMS) programs help ensure that the benefits of certain high-risk medications outweigh their risks. With the routine use of REMS programs, however, concerns ...

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 ...

Using chimeric antigen receptor (CAR) T-cell therapies for blood cancer should be less burdensome following labeling updates from the FDA. In a June 26 letter to Janssen explaining the move, the ...

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 ...

Health care providers will no longer need to do extra monitoring beyond what is expected with standard clinical care. The Food and Drug Administration (FDA) has deemed the Risk Evaluation and ...