Postmarket Drug Safety Information for Patients and Providers > Approved Risk Evaluation and Mitigation Strategies (REMS)

Approved Risk Evaluation and Mitigation Strategies (REMS)

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. The table below provides a list of REMS that have been approved by FDA.

Postmarket Drug Safety Information for Patients and Providers > Approved Risk Evaluation and Mitigation Strategies (REMS)