Question:

What is the Drug Safety Oversight Board?

Answer:

The Drug Safety Oversight Board (DSB), created in 2005 and mandated by law in the Food and Drug Administration (FDA) Amendments Act of 2007, advises the Center for Drug Evaluation and Research (CDER) Center’s director on the handling and communicating of important and often emerging drug safety issues. The DSB meets monthly and provides a forum for discussion and input about how to address potential drug safety issues.

The DSB is composed of representatives from two FDA centers and other federal government agencies including the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS. An important role of the DSB is to help the FDA assess the impact of their safety decisions on the healthcare systems of its federal partners. The board, with its broad representation from federal healthcare organizations, provides valuable input and allows the FDA to hear other perspectives on drug-safety issues.

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