iPLEDGE Risk Evaluation and Mitigation Strategy (REMS)

[FDA]

The iPLEDGE REMS was originally implemented in early 2005. The goals of the iPLEDGE REMS are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions. It is a “shared system” REMS, meaning that it incl


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