World of Compliance Module

Risk Evaluation and Mitigation Strategies (REMS)

In December 2007, the Food and Drug Administration Amendments Act (FDAAA) gave FDA the authority to require sponsors to develop and comply with risk evaluation and mitigation strategies (REMS).

Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

REMS apply to prescription drugs, biologics and generics with special limitations.

Before a drug is approved, FDA may determine a REMS is needed to ensure that the benefits of the drug outweigh the risks of the drug.