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    Considering Risk Evaluation and Mitigation Strategies (REMS)

    Every drug comes with some risk. The key issue for regulators, drugmakers, healthcare professionals and patients alike is whether the likely benefit is greater than the risk. This is the question reviewers at the US Food and Drug Administration (FDA) must grapple with in determining whether or not to approve a new product or to leave an already approved product on the market in light of new information about adverse events or other potential negative consequences. In some...