Monday, May 4, 2015

Topic: Risk Evaluation and Mitigation Strategies (REMS)

Risk Evaluation and Mitigation Strategies (REMS)

REMS are requirements set by the Food and Drug Administration (FDA) for pharmaceutical manufacturers to help ensure that the benefits outweigh the risks for certain drugs. There are several components of REMS that can be used by the pharmaceutical industry, including one or more of the following:

Medication Guides or Patient Package Inserts

FDA-approved instructions for appropriate use and instructions for patients focused on avoiding serious adverse events

Communication Plans

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