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 ...
Test for pregnancy in medical setting before starting isotretinoin, then can be done at ho ...
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 ...
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 ...
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 ...