Why 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. Additional REMS Information.
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. Additional REMS Information.
The three tables below provide separate lists for:
- Currently Approved Shared System REMS
-- Buprenorphine Transmuscosal Products for Opioid Dependence (BTOD) REMS
-- Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS
-- Isotretinoin iPLEDGE REMS
-- Mycophenolate REMS
-- Rosiglitazone REMS
-- Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS
