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REMS Integration Initiative Aims to Standardize REMS and Encourage Better Integration into the Health Care System

September 12, 2013
By Terry Toigo, Office of the Center Director The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized FDA to require a Risk Evaluation and Mitigation Strategy (REMS) if it is determined — either during initial product review or at any point in the postmarketing period — that specific safety measures are needed to ensure that a drug’s benefits outweigh its risks. REMS serve to inform and educate patients and health care providers about the serious risks of a...

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