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Four common missed opportunities when designing and developing a REMS program

A Risk Evaluation and Mitigation Strategy (REMS) is a complex and evolving safety program. Although the US Food and Drug Administration (FDA) ultimately determines if a REMS program is necessary, there may be more opportunities than you might realize to shape the development of your program. Proactive engagement with the FDA, for example, can make a critical difference in reducing timelines, limiting confusion, and agreeing to reasonable requirements. Here we discuss four common missed opportunities when developing a REMS program.

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