The DSB, created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the CDER Center 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 eight other federal government agencies, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Department of Veterans Affairs (VA). An important role of the DSB is to help 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, can provide valuable input and allows FDA to hear other perspectives on drug safety issues.