The Complicated World of REMS
Unwinding Risk Mitigation
IN 2007, with the passage of the Food and Drug Administration (FDA) Amendments Act, the FDA was granted new authority to require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug outweigh its risks. An REMS, which can be required at the time a drug is approved and/or once it has gone to [...]


