The REMS in Practice: Recent Trends

| 01 July 2010

In the drug approval process, the US Food and Drug Administration (FDA) must balance the demand for approval of new therapies with the need to ensure the safety of products that have only been tested in clinical trials studying a limited number-hundreds to thousands-of patients. The 2007 Food and Drug Administration Amendments Act (FDAAA)1 grants FDA the authority to require Risk Evaluation and Mitigation Strategies (REMS) to be implemented postapproval when deemed necessary for a favorable risk/benefit balance for a product.


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