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The 2007 Food and Drug Administration Amendments Act gave the agency authority to require a manufacturer to submit and carry out a Risk Evaluation Mitigation Strategy (REMS) for selected biologics or drugs to ensure a product’s benefits outweigh its risks as a condition of the product’s approval. FDA issued its first guidance under this authority in 2009. The elements of a REMS included a variety of communication devices to help inform the patient about using the therapy, such as medication guides and patient package inserts; a communication plan for the healthcare provider; and other elements to ensure safe use of the product aimed at the prescriber, dispenser, and the patient. The draft guidance addressed the format and content of the REMS, its assessment, and a timetable for submitting it.

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