But now there is the option of something stronger, known as a risk mitigation and evaluation strategy (REMS).
The Risk Evaluation and Mitigation Strategy (REMS) targets extended-release (ER) and long-acting (LA) opioid drugs, including prescription medications containing oxycodone hydrochloride.
There were fears that FDA would saddle Merck with an onerous Risk Evaluation and Mitigation Strategy (REMS) program, which could reduce sales.
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Because vandetanib affects the electrical activity of the heart, potentially lethally, it is being sold under a Risk Evaluation and Mitigation Strategy (REMS).
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In order to get approved, Qnexa will probably need a risk evaluation and mitigation strategy (REMS), post-market studies, and warnings in its label, Carr says.
Because of the risk of liver toxicity, JUXTAPID is available only through a restricted program called the JUXTAPID Risk Evaluation and Mitigation Strategy (REMS) Program.
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The FDA approved Kynamro with a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription.
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Investors are expecting that there will not be a black box warning on the drug, and that any Risk Evaluation and Mitigation Strategy (REMS) plan these are special plans designed to limit who gets a medicine will be relatively lights.
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The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class.
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