The Food and Drug Administration risk evaluation and mitigation strategy.

摘要

The Food and Drug Administration Amendments Act of 2007 extended the agency's regulatory authority over drug products that have been shown to place patients at risk. This Act authorizes the FDA to require pharmaceutical manufacturers and distributors to ensure that the safety of their products continue to outweigh the risks. This article discusses in more detail the proposed elements of an acceptable Risk Evaluation and Mitigation Strategy (REMS) for any drug product, including extended-release opioid analgesics.