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

September 12, 2013 at 11:16 AM
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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