Simplifying Global Compliance
Isotretinoin REMS Proving Effective, Drugmaker Complaints Muted
Washington Drug Letter
Drugmakers have cited the risk evaluation and mitigation strategy (REMS) for acne drug isotretinoin as one of the FDA’s more burdensome REMS, but industry officials and experts are now applauding the program, with some calling it a perfect pilot candidate for standardization.
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