Most physicians said the positives of clozapine's REMS outweighed its negatives. Most also said that mandatory blood testing was necessary, but it created a burden and medication delays. In 2024, an ...

A joint FDA advisory committee on Tuesday overwhelming voted to eliminate the risk evaluation and mitigation strategy (REMS) program designed around the risk for severe neutropenia associated with ...

We have previously reported on the Risk Evaluation and Mitigation Strategy (REMS) program, its effect on generic development, and the FDA’s guidance on how to prevent brands from using the REMS ...

The FDA still recommends prescribers monitor patients’ ANC levels according to the prescribing information. The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation ...

The FDA’s REMS policy, designed to ensure drug safety, is instead harming individuals with treatment-resistant schizophrenia by imposing burdensome requirements on clozapine, the only FDA-approved ...

According to the FDA, the labeling alone should be adequate to communicate the risk of embryofetal toxicity. The Food and Drug Administration (FDA) has removed the Risk Evaluation and Mitigation ...

The Food and Drug Administration’s requirements for e-prescribing and risk evaluation for controlled substances can be burdensome for pain physicians, according to a MedPage Today news report. Under ...

For 35 years, the FDA has placed onerous restrictions on the only drug it has ever approved for treatment-resistant schizophrenia, and the only one it recognizes as reducing the risk of suicide. This ...

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 ...