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MARCH 10, 2017

REMS Programs Help FDA, Stakeholders Work Together to Enhance Drug Safety

By Theresa Toigo, MBA, RPh, and Cynthia LaCivita, PharmD

When prescribing or dispensing a drug, you may be required to take specific safety steps prior to the patient receiving the medication. Those measures may be part of an FDA-required safety program called Risk Evaluation and Mitigation Strategies (REMS).

REMS programs are FDA-required drug safety measures designed to reduce a known or potential risk identified in a product’s prescribing information. Pharmaceutical companies must