Leveraging Technology to Cut Through the REMS Confusion

The Risk Evaluation and Mitigation Strategies (REMS) program has taken center stage recently as the Food and Drug Administration (FDA), pharmacies and healthcare providers seek ways to improve and streamline its administration. Created in 2007 as part of the FDA Amendments Act, REMS was designed to ensure that the benefits of a drug or biological product outweigh its risks, as well as for post-marketing surveillance of medication safety. While providers agree with these goals, many are also concerned with issues they believe are preventing REMS from achieving its objectives.

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