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The agency streamlines risk and mitigation information.
FDA has launched its new Risk Evaluation and Mitigation Strategies (REMS) website. REMS controls were created as part of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which gave FDA the authority to require REMS from manufacturers so the agency could ensure that the benefits of a drug product outweigh the potential risks. A REMS creates a strategy for managing serious risks associated with a drug. FDA may require a REMS for approval of a new drug or when there is new safety information on an already approved drug.
The new website has streamlined REMS information into one easy-to-use table that includes currently approved and shares-system REMS, instead of the multiple tables and databases previously found on FDA’s website. The searchable table includes the medication guide, communication plan, ETASU (Elements to Assure Safe Use), and implementation system for each drug or biologic. Historical and released REMS can be downloaded from the website.