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But the most effective new power has been the risk evaluation and mitigation system (REMS).
FORBES: The End Of Drug Withdrawals?
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The FDA has just released the actual Risk Evaluation and Mitigation System (REMS) for Avandia and companion drugs Avandaryl and Avandamet.
FORBES: Avandia -- When A Drug Is On The Market, But Not Really
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But Sabril needed a Risk Evaluation and Mitigation System (REMS), FDA jargon for a plan that ensures drugs are only used when benefits outweigh risks.
FORBES: Magazine Article
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At first glance, it seems that this risk evaluation and mitigation system (REMS) is not as onerous as it might have been, and that may leave the FDA open to further criticism.
FORBES: Avandia Saved By The Power of REMS
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The Obama administration has required stricter evaluation systems as a condition for certain grants, and the city is at risk of losing hundreds of millions of dollars in federal funding if an evaluation system isn't put in place.
WSJ: Deadline on Evaluations
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State Commissioner of Education John King had asked for the information in a letter to the city last month, saying the city was at risk for losing more aid if it couldn't show that it was taking steps to prepare for a new evaluation system.
WSJ: NYC outlines teacher training, evaluation goals