The iPLEDGE program is a risk evaluation and mitigation strategy (REMS). The Food and Drug Administration (FDA) may require a REMS to help ensure that a medication’s benefits outweigh its risks. A ...
The long-awaited modifications for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) system for the teratogenic acne drug isotretinoin, previously scheduled to go into effect August 8, 2026, ...