Summary

It has been more than a decade since the Food and Drug Administration Amendments Act (FDAAA) was signed into law in September 2007. The Act enabled the FDA to mandate Risk Evaluation and Mitigation Strategy (REMS) programs for products that are approved but require specific steps be taken to assure safe use. Since then, REMS programs have evolved in both scope and complexity but the use of new technologies to relieve the burden a REMS can place on prescribers, pharmacists, other healthcare providers (HCPs) and/or patients has not kept pace. 

 

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